R E S E A R CH A R T I C L E
Adaptation and validation of the Physical Restraint-Theory
of Planned Behaviour Questionnaire to the paediatric context
Alejandro Bosch Alcaraz PhD, RN, MSc1,2 | Pedro Piqueras Rodríguez RN, MSC3,4 |
Jesús Corrionero Alegre RN, MSC5 | José Miguel García Piñero PhD, RN, MSc6 |
Sylvia Belda Hofheinz PhD, MD7 | Sonia Gil Domínguez RN7 |
Esperanza Zuriguel Pérez PhD, RN, MSc8,9 |
Patricia Luna Castaño PhD, RN, MSc10,11 | M. A´ngeles Saz Roy PhD, RN, MSc1,2 |
Marta Martínez Oliva RN5 | Susana González Rivas RN5 |
Nerea Añaños Montoto RN5 | María José Espildora González RN6 |
Elena Martín-Peñasco Osorio RN6 | Eva Carracedo Muñoz RN7 |
Eduardo López Fernández MD7 | Gema Lozano Almendral RN3 |
Alicia Gomez Merino RN3 | David Morales Cervera RN3 |
Rocío Fernández Lorenzo RN, MSc12 | María Mata Ferro RN, MSc12 |
Ainhoa Martín Gómez RN12 | Marta Serradell Orea RN12 |
Cristina Esquinas López PhD, RN, MSc1 | Gemma Via Clavero PhD, RN, MSc13,14,15,16
1Department of Public Health, Mental Health and Maternal and Child Health Nursing, Faculty of Nursing, University of Barcelona (UB), Barcelona, Spain
2Mental Health, Psychosocial and Complex Nursing Care Research Group-NURSEARCH, University of Barcelona, Barcelona, Spain
3Pediatric Intensive Care Unit, La Paz Hospital, Madrid, Spain
4Health Research Institute, La Paz Hospital – IdiPAZ, Madrid, Spain
5Pediatric Intensive Care Unit, Vall Hebron Hospital, Barcelona, Spain
6Pediatric Intensive Care Unit, Carlos Haya Hospital, Málaga, Spain
7Pediatric Intensive Care Unit 12 de Octubre Hospital, Madrid, Spain
8Department of Knowledge Management and Evaluation, Vall d'Hebron Hospital, Barcelona, Spain
9Multidisciplinary Nursing Research Group, Vall d'Hebron Research Institute (VHIR), Barcelona, Spain
10Alfonso X el Sabio University, Madrid, Spain
11Health Care and Services Research Unit (Investén-ISCIII), Madrid, Spain
12Pediatric Intensive Care Unit, Sant Joan de Déu Hospital, Barcelona, Spain
13Hospital Universitari de Bellvitge, Barcelona, Spain
14Faculty of Nursing, University of Barcelona (UB), Barcelona, Spain
15Nursing Research Group (GRIN), Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain
16International Research Project for the Humanization of Health Care, Proyecto HU-CI, Madrid, Spain
Received: 1 November 2023 Revised: 7 March 2024 Accepted: 11 March 2024
DOI: 10.1111/nicc.13066
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any
medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
© 2024 The Authors. Nursing in Critical Care published by John Wiley & Sons Ltd on behalf of British Association of Critical Care Nurses.
Nurs Crit Care. 2024;1–14. wileyonlinelibrary.com/journal/nicc 1
Correspondence
Alejandro Bosch Alcaraz and M. A´ngeles Saz
Roy, Department of Public Health, Mental
Health and Maternal and Child Health Nursing,
School of Nursing, Faculty of Medicine and
Health Sciences, University of Barcelona (UB),
Barcelona, Spain
Email: alejandrobosch@ub.edu; masazroy@
ub.edu
Abstract
Objective: To create and test psychometrically a paediatric version of the Physical
Restraint-Theory of Planned Behaviour Questionnaire to assess paediatric critical
care nurses' intention to use physical restraint.
Design: A psychometric study.
Setting: Five medical-surgical Paeditric Intensive care Units from five hospitals in
Spain.
Methods: The study took place in three phases. In phase 1, the questionnaire was
adapted. In phase 2, the content validity of each item was determined, and a pilot
test was conducted. In phase 3, we administered the questionnaire and determined
its psychometric properties.
Results: The assessment of the intention to use physical restraint was extended to
all critical paediatric patients, two items were eliminated from the initial question-
naire, four new items were included, and the clinical scenarios of the intention sub-
scale were expanded from three to six. Overall content validity index for the full
instrument of 0.96 out of 1. The Paediatric Physical Restraint-Theory of Planned
Behaviour Questionnaire is made up of four subscales (attitude, subjective norms
(SN), perceived behavioural control (PBC), and intention) subdivided into 7 factors
and 51 items. The internal consistency for the attitude subscale obtained a Cron-
bach's Alpha of 0.80 to 0.73, for the SN it was 0.72 to 0.89, for the PBC it was from
0.80 to 0.73 and for the intention subscale it was 0.75.
Conclusions: The Paediatric Physical Restraint-Theory of Planned Behaviour Ques-
tionnaire is an instrument composed of seven factors and 51 items that validly and
reliably assesses the intention of paediatric nurses to apply PR in PICUs.
Relevance for Clinical Practice: Having this instrument will help health centres
move towards restraint-free care by allowing managers to assess professionals' atti-
tudes, beliefs, and intentions around the use of PR in PICUs.
K E YWORD S
intensive care unit, nursing, paediatric, psychometric studies, restraint physical
1 | INTRODUCTION
The comprehensive care of paediatric patients, in any clinical context
(primary, hospital and/or specialized care), requires the performance
of various diagnostic and/or therapeutic procedures that, in addition
to causing pain and physical discomfort, cause great psychological
stress. When the child's behaviour, as a result of a lack of understand-
ing about the intervention being carried out, prevents the application
of a treatment and the achievement of the therapeutic goals, care pro-
fessionals consider the exceptional use of physical restraints (PR) or
pharmacological restraints, with the aim of guaranteeing safety.1,2
Paediatric intensive care units (PICUs), in particular, provide care
for children whose condition puts their lives at real or potential risk.
The comprehensive management of these patients is usually invasive,
requiring numerous diagnostic and therapeutic procedures.3 Some
authors report that for this reason PR is applied in PICUs to carry out
certain painful procedures1,4–8 and to ensure the maintenance and
continuity of life support devices, such as endotracheal tubes, vascular
catheters, catheters, or drains. In this way, care professionals try to
prevent unplanned adverse effects related to patient safety.9–11 Even
so, the effectiveness of PR with these objectives is still uncertain, so it
should only be used when collaborative alternatives have been
exhausted.12,13
1.1 | Background
The concept of PR in paediatrics is ambiguous.14,15 It is sometimes
called clinical or supportive holding or restraint. The first refers to
“positioning a child so that a medical procedure can be carried out in a
safe and controlled manner, wherever possible with the consent of
child and parent/carer.”16 In contrast, “restraint is used to administer
2 BOSCH ALCARAZ ET AL.
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
medication or carry out a procedure to which the child objects, and is
carried out in what is considered to be in the child's best interest.”17
At the same time, it is essential to differentiate between PR and physi-
cal restriction which is standard practice for certain procedures. Physi-
cal restriction is applied in paediatrics to perform invasive procedures,
such as safely placing a peripheral venous catheter. Even so, and
despite the fact that physical restriction lasts less time than PR, stud-
ies by Brenner et al. conclude that its use is very stressful and not
beneficial for the child, in addition to leading to feelings of helpless-
ness and vulnerability.18 Therefore, the shorter duration of physical
restriction does not appear to protect against related physical and
psychological adverse events.
Demir et al.1 observed in a study in Turkey that the use of
restraints was less common in accompanied patients, in line with
another carried out in 40 hospitals in the United States that concludes
that the use of PR in PICUs is much less common than that of adult
critical care units, where round-the-clock accompaniment by family is
not permitted.19
Health professionals working in PICUs should be aware that PR
leads to adverse physical and psychological events in the paediatric
patient, and for this reason, experts are committed to minimizing its
use and implementing strategies to practice restraint-free care.9,12–14
Research shows that informing and involving the family and the child
in all decisions and therapeutic procedures—a key function of
nurses—is essential to ensure patient collaboration and reduce the use
of PR.20 Even so, there is a gap between the recommendations of clin-
ical practice guidelines and the practices of professionals, especially
when it comes to ceasing a specific behaviour, such as the use of
PR. For this reason, it is necessary to analyse the factors that influ-
ence the behaviour or intention to apply PR. We propose doing so
using the framework of the theory of planned behaviour.9,21
In the late 1960s, after the realization that a person's attitudes
alone cannot predict their behaviour, psychologists began to generate
predictive models such as the theory of reasoned action and its exten-
sion, the theory of planned behaviour.6,22 The theory of reasoned
action poses that intention is the antecedent to behaviour and that
intention is influenced by attitude, by subjective norms, by beliefs
about the consequences of the conduct in question, and by the nor-
mative beliefs perceived by the individual.9,22,23 Ajzem & Fishbein
(1980) signalled that the theory of reasoned action was useful to
describe conducts that are under the control of the person, assuming
that the person has absolute control without external pressure to
adopt a certain behaviour. Yet, Ajzen (1985) observed that many con-
ducts do not follow this pattern because people's perception of their
degree of control over a given behaviour can range from no control to
total control. For this reason, Ajzan developed the theory of planned
behaviour as an extension of the theory of reasoned action, adding to
the original model the notion of perceived behavioural control. One
application is in evaluating health professionals' adherence to clinical
guidelines or in conducting a procedure with a specific population
group.9,24–26
This approach has only been used in adult critical patients in
Spain,14 in nurses in Malaysia,27 and in a study in nursing homes
in Israel that evaluates intention through the theory of reasoned
action.28 An advantage of the theory of planned behaviour approach
is that behaviour is evaluated according to the TACT principle (target,
action, context, and time). Because the original instrument was cre-
ated for the adult context,9 it requires adaptation and validation for
use in paediatric critical care nurses.
2 | THE STUDY
2.1 | Aim
To create and test psychometrically a paediatric version of the Physi-
cal Restraint-Theory of Planned Behaviour Questionnaire9 to assess
paediatric critical care nurses' intention to use PR.
2.2 | Materials and methods
2.2.1 | Design
A psychometric, analytical, correlational, and prospective study was
carried out from October 2021 to January 2023 in which five PICUs
from five hospitals in Spain participated: Sant Joan de Déu Children’s
Hospital (Barcelona), Vall d'Hebron Hospital (Barcelona), La Paz Uni-
versity Hospital (Madrid), 12 Octubre Hospital (Madrid) and Carlos
Haya Regional University Hospital (Málaga) The study took place in
three phases. In phase 1, the questionnaire was adapted to critically ill
paediatric patients. In phase 2, the content validity of each item was
What is known about the topic
• The comprehensive management of critically ill paediatric
patients is usually invasive, requiring numerous diagnostic
and therapeutic procedures.
• Physical restraint is applied in Paediatric Intensive Care
Units to carry out certain painful procedures and to
ensure the maintenance and continuity of life support
devices.
• Physical restraint leads to adverse physical and psycho-
logical events in critically ill paediatric patients.
What this paper adds
• This is the first study to adapt and validate an instrument
to assess nurses' intentions to use physical restraint in
the paediatric context.
• The availability of this tool will help health centres to
move towards restraint-free care by enabling managers
to assess the attitudes, beliefs and intentions of profes-
sionals regarding the use of physical restraint in PICUs.
BOSCH ALCARAZ ET AL. 3
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
determined, and a pilot test was conducted. In phase 3, we adminis-
tered the questionnaire and determined its psychometric properties. It
was conducted following the Strengthening the Reporting of Obser-
vational Studies in Epidemiology (STROBE) statement29 and the Con-
sensus-Based Standards for the Selection of Health Measurement
Instruments (COSMIN) guideline.30,31
2.2.2 | Study population and sample
To conduct phases 1 and 2 of the study, we recruited small groups of
paediatric nurses from a single centre with a minimum of 5 years
working in paediatric critical care. In phase 1, six participants adapted
the questionnaire to the context of paediatric critical care and in
phase 2, eight participants validated the content and 10 filled out the
questionnaire in a pilot test.
For the subsequent psychometric analysis (phase 3), all nurses
from the five collaborating centres who met the following selection
criteria were asked to fill out the questionnaire:
Inclusion criteria:
• Documented training in paediatrics (master's degree, speciality
and/or continuing education courses).
• Minimum work experience in PICU of 2 years.
• Complete informed consent document.
Exclusion criteria:
• Working <30% of full time.
• On sick leave, disability, or leave of absence.
2.2.3 | Study variables
For participants in the psychometric study (phase 3), the following
sociodemographic and occupational characteristics were recorded:
(i) age (in years); (ii) level of studies (undergraduate, master's, specialty,
doctorate); (iii) experience as a nurse (years); (iv) experience in paedi-
atrics (years); (v) experience in PICU (years); (vi) type of contract (fixed
term, full-time interim, part-time interim [weekends], temporary or
other), (vii) work shift (morning, afternoon, day [12 h], evening
or rotating) and (viii) specific training in PR (yes [specify] / no). At the
same time, participants' responses to the items of the Physical
Restraint-Theory of Planned Behaviour Questionnaire were recorded.
2.2.4 | Data collection tools
The main instrument was the Physical Restraint-Theory of Planned
Behaviour Questionnaire on the intention of ICU nurses to use PR in
the adult intubated patient from the perspective of the theory of
planned behaviour.9
The original questionnaire, composed of 48 items, is organized
into four subscales according to the constructs of the theoretical
model of the theory of planned behaviour (attitudes, subjective
norms, perceived behavioural control, and intention to use PR in the
intubated adult patient). After the psychometric analysis, adequate
reliability and validity data were obtained, with an internal consistency
determined by Cronbach's Alpha >0.60 in all its subscales and dimen-
sions and good temporal stability, except for the indirect subjective
norm. In addition, confirmatory factor analysis showed a good fit with
the theoretical model with nine factors organized in seven dimen-
sions.9 We adapted and validated the subscales related to attitudes,
subjective norms, and perceived behavioural control for use in the
PICU, and we designed and validated the intention subscale for use in
the PICU.
The scales for attitudes, subjective norms, and perceived beha-
vioural control are formed by a reflective indicator and a correspond-
ing composite formative indicator of beliefs. Each dimension is
evaluated individually and, therefore, the scores are specific to each.
2.2.5 | Data collection procedure
The adaptation and validation process was carried out in three
phases.
Phase 1: Adaptation of the instrument to the PICU.
To carry out this phase, we used the Delphi method.32 Participat-
ing in this phase were nurses who were experts in the management of
paediatric critical patients, with a minimum of 5 years' work
experience in the PICU. Potential participants were contacted by
email, telephone or in person. Participation was voluntary. Before the
first meeting, those who had agreed to participate received via email
or post the questionnaire to be evaluated and the informed consent
document. Considering that Polit and Beck33 recommend a minimum
of five experts, a total of six participants were selected.
Three meetings were held. The main objective of the first meeting
was to qualitatively assess the items to adapt them to the PICU and
to design the clinical cases for the intention subscale. These cases
were designed based on the clinical situations that motivate the most
uses of PR in PICUs, according to our literature review. We included
participants of different ages, sex, reason for admission, number of
clinical devices, and clinical evolution (sedated patients, those in the
process of weaning, unaccompanied and accompanied patients, etc.).
Subsequently, a second meeting was held in which the main author of
the original instrument was invited to reassess the modified question-
naire. Finally, a third meeting was held in which the information was
synthesized, the proposed changes to the instrument were made, and
the definitive paediatric questionnaire was developed.
During the content validation process through expert opinions
and Delphi methodology, the assessment of the intention to use PR
was extended to all critical paediatric patients (not just intubated
ones), two items were eliminated from the initial questionnaire, four
new items were included, and, in addition, the clinical scenarios of the
intention subscale were expanded from three to six (Table 1).
Phase 2: Content validation and pilot testing.
Once the paediatric instrument was created, its content was vali-
dated. To this end, we developed an ad hoc document containing all
4 BOSCH ALCARAZ ET AL.
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
TABLE 1 Semantic and item differences between the Physical Restraint-Theory of Planned Behaviour Questionnaire and the paediatric
version.
Physical Restraint-Theory of Planned Behaviour Questionnaire items Paediatric versiona
1. In my opinion, the use of physical restraints in intubated patients is
unsafe/safe
1. In my opinion, the use of physical restraints in critically ill paediatric
patients is unsafe / safe
2. In my opinion, the use of physical restraints in intubated patients is
unnecessary/necessary
2. In my opinion, the use of physical restraints in critically ill paediatric
patients is unnecessary / necessary.
3. In my opinion, the use of physical restraints in intubated patients is
harmful/beneficial
3. In my opinion, the use of physical restraints in critically ill paediatric
patients is harmful / beneficial.
4. In my opinion, the use of physical restraints in intubated patients is
unacceptable/acceptable
4. In my opinion, the use of physical restraints in critically ill paediatric
patients is unacceptable/acceptable
5. If I use physical restraints in an intubated patient, I will prevent self-
extubation.
5. If I use physical restraints in a critically ill paediatric patient, I will
prevent self-extubation.
6. If I use physical restraints in an intubated patient, I will prevent self-
removal of catheters/tubes.
6. If I use physical restraints in a critically ill paediatric patient, I will
prevent self-removal of catheters/tubes.
7. If I use physical restraints in an intubated patient, I will prevent falls. 7. If I use physical restraints in a critically ill paediatric patient, I will
prevent falls.
8. If I cannot permanently monitor an intubated patient, I will feel more
relieved when they are wearing physical restraints.
8. If I cannot permanently monitor a critically ill paediatric patient, I will
feel more relieved when they are wearing physical restraints.
9. If I use physical restraints, I will have more time to perform my tasks. 9. If I use physical restraints, I will have more time to perform my tasks.
10. If I use physical restraints, the intubated patient becomes more
agitated.
10. If I use physical restraints, the critically ill paediatric patient becomes
more agitated.
11. The use of physical restraints in an intubated patient can cause skin
injuries.
11. The use of physical restraints in a critically ill paediatric patient can
cause skin injuries.
12. The use of physical restraints in intubated patients upsets me. 12. The use of physical restraints in critically ill paediatric patients upsets
me.
13. In my opinion, preventing self-extubation is extremely undesirable/
extremely desirable.
13. In my opinion, preventing self-extubation in critically ill paediatric
patients is extremely undesirable / extremely desirable.
14. In my opinion, preventing self-removal of catheters and probes is
extremely undesirable/extremely desirable.
14. In my opinion, preventing self-removal of catheters and probes in
critically ill paediatric patients is extremely undesirable/extremely
desirable.
15. In my opinion, preventing intubated patients from falling is
extremely undesirable / extremely desirable.
15. In my opinion, preventing intubated critically ill paediatric patients
from falling is extremely undesirable/extremely desirable.
16. In my opinion, feeling relieved whenever I cannot monitor an
intubated patient is extremely undesirable / extremely desirable.
16. In my opinion, feeling relieved whenever I cannot monitor a critically ill
paediatric patient is extremely undesirable/extremely desirable.
17. In my opinion, having more time to perform my tasks is extremely
undesirable / extremely desirable.
17. In my opinion, having more time to perform my tasks is extremely
undesirable/extremely desirable.
18. In my opinion, if an intubated patient becomes more agitated as a
result of the use of physical restraints, it is extremely undesirable/
extremely desirable.
18. In my opinion, if a critically ill paediatric patient becomes more
agitated as a result of the use of physical restraints, it is extremely
undesirable/extremely desirable.
19. In my opinion, if physical restraints injure a patient's skin, it is
extremely undesirable/extremely desirable.
19. In my opinion, if physical restraints injure a critically ill paediatric
patient's skin, it is extremely undesirable / extremely desirable.
20. In my opinion, if using physical restraints in intubated patients
makes me feel unease, it is extremely undesirable/extremely
desirable.
20. In my opinion, if using physical restraints in critically ill paediatric
patients makes me feel unease, it is extremely undesirable/extremely
desirable.
21. I use physical restraints in intubated patients because professionals
with whom I work think that they must be used.
21. I use physical restraints in critically ill paediatric patients because
professionals with whom I work think that they must be used.
Not included 22. I feel under social pressure when I don't use mechanical restraints in
critically ill paediatric patients.
Not included 23. Other professionals in my place use mechanical restraints on
paediatric critical patients.
22. I am expected to use physical restraints in intubated patients. 24. I am expected to use physical restraints in critically ill paediatric
patients.
23. My nursing colleagues disapprove of me using physical restraints in
intubated patients.
25. My nursing colleagues disapprove of me using physical restraints in
critically ill paediatric patients.
(Continues)
BOSCH ALCARAZ ET AL. 5
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
TABLE 1 (Continued)
Physical Restraint-Theory of Planned Behaviour Questionnaire items Paediatric versiona
24. My unit supervisor disapproves of me using physical restraints in
intubated patients.
26. My unit supervisor disapproves of me using physical restraints in
critically ill paediatric patients.
25. My doctor colleagues disapprove of me using physical restraints in
intubated patients.
27. My doctor colleagues disapprove of me using physical restraints in
critically ill paediatric patients.
26. Patients' relatives disapprove of me using physical restraints in
intubated patients.
28. Patients' relatives disapprove of me using physical restraints in
critically ill paediatric patients.
27. My nursing colleagues' approval of my practice towards the use of
physical restraints is important to me.
29. My nursing colleagues' approval of my practice towards the use of
physical restraints is important to me.
28. My nursing supervisor's approval of my practice towards the use of
physical restraints is important to me.
30. My nursing supervisor's approval of my practice towards the use of
physical restraints is important to me.
29. My doctor colleagues' approval of my practice towards the use of
physical restraints is important to me.
31. My doctor colleagues' approval of my practice towards the use of
physical restraints is important to me.
30. Patients' relatives' approval of my practice towards the use of
physical restraints is important to me.
32. Patients' relatives' approval of my practice towards the use of physical
restraints is important to me.
31. I am confident that I could use physical restraints in intubated
patients if I decide to.
33. I am confident that I could use physical restraints in critically ill
paediatric patients if I decide to.
32. It is easy for me to make the decision to use physical restraints in
intubated patients.
34. It is easy for me to make the decision to use physical restraints in
critically ill paediatric patients.
33. The decision to use physical restraints in intubated patients is
entirely up to me.
35. The decision to use physical restraints in critically ill paediatric patients
is entirely up to me.
Not included 36. The age of the critically ill paediatric patient reduces the use of
mechanical restraints. (Eliminated as a result of low factorial load in
confirmatory factor analysis)
34. When an intubated patient cooperates, it reduces the use of
physical restraints.
37. When a critically ill paediatric patient cooperates, it reduces the use of
physical restraints.
35. Whenever a patient is undergoing a weaning or an awakening trial, it
increases the use of physical restraints.
38. Whenever a patient is undergoing a weaning or an awakening trial, it
increases the use of physical restraints.
36. Family presence at the bedside reduces the use of physical restraints
in an intubated patient.
39. Family presence at the bedside reduces the use of mechanical
restraints in a critically ill paediatric patient.
37. Pharmacological management of agitation avoids having to use
physical restraints in an intubated patient.
40. Pharmacological management of drug withdrawal syndrome reduces
the use of mechanical restraints in a critically ill paediatric patient.
38. The reassessment of the patient's medical situation reduces the use
of physical restraints.
Item deleted
39. Communication between the multidisciplinary team reduces the use
of physical restraints in an intubated patient.
41. Communication between the multidisciplinary team reduces the use of
physical restraints in a critically ill paediatric patient.
Not included 42. I am more likely to use physical restraints if the patient is younger.
(Eliminated as a result of low factorial load in confirmatory factor
analysis)
40. I am more likely to use physical restraints if the intubated patient
cooperates.
43. I am more likely to use physical restraints if the critically ill paediatric
patient cooperates.
41. I am more likely to use physical restraints if the patient is
undergoing a weaning or an awakening trial.
44. I am more likely to use physical restraints if the critically ill paediatric
patient is undergoing a weaning or an awakening trial.
42. I am more likely to use physical restraints if a family member is
accompanying the patient.
45. I am more likely to use physical restraints if a family member is
accompanying the critically ill paediatric patient at the bedside.
43. I am more likely to use physical restraints if I can administer a drug
to manage the patient's agitation.
46. I am more likely to use physical restraints if I can administer a drug to
manage the critically ill paediatric patient's drug withdrawal syndrome.
44. I am more likely to use physical restraints if I reassess the patient's
clinical status.
Item deleted
45. I am more likely to use physical restraints if the patient's clinical
status is discussed among the multidisciplinary team.
47. I am more likely to use physical restraints if the patient's clinical status
is discussed among the multidisciplinary team.
46. Scenario 1
A 65-year-old male with a past medical history of high blood pressure
under treatment and dyslipidemia, who is admitted to the ICU (private
room) following a coronary artery triple bypass. Upon admission, he
48. Scenario 1
A 6-year-old male child with Down syndrome and a medical history of
atrioventricular canal defect is admitted to the PICU (private room)
following surgery to close a ventricular septal defect using sutures and
6 BOSCH ALCARAZ ET AL.
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
TABLE 1 (Continued)
Physical Restraint-Theory of Planned Behaviour Questionnaire items Paediatric versiona
has an orotracheal tube connected to mechanical ventilation, a central
venous catheter in the subclavian artery, radial arterial line,
nasogastric tube, urinary catheter, temporary pericardial pacing wires
and chest tubes connected to a suction system. The patient's
haemodynamic status is stable, and sedation is progressively titrated
in order to start weaning. The patient is able to open his eyes to
verbal stimulation for less than 10 seconds (RASS-2) and responds to
information with his head (yes/no).
an atrial septal defect using a patch. Upon admission, the patient is
equipped with an orotracheal tube connected to mechanical ventilation,
a central venous catheter inserted through the right jugular, a left radial
arterial catheter, a nasogastric tube, a urinary catheter, an external
pacemaker lead, and thoracic drains (pleural and pericardial) connected
to an aspiration system. Hemodynamically, the patient remains stable,
albeit supplemented with low-dose inotropic support. Upon admission
to the unit, the process of weaning is initiated with the progressive
withdrawal of analgo-sedation. The patient gradually emerges from
sedation, displaying responsive behaviours such as eye-opening and
consistent movement of all four limbs and the head. The patient
intermittently interacts with the orotracheal tube by tactile
manipulation and, during one instance, exhibits intentional grasp of the
pericardial drainage catheter. The parents are brought to the cubicle.
Despite their apprehension, they understand the situation and try to
help the patient relax.
47. Scenario 2
A 28-year-old male with a past medical history of smoking (one packet a
day) and moderate alcohol abuse, who is admitted to the ICU (private
room) with severe traumatic brain injury. During the previous
2 weeks, he has been administered analgo-sedation with midazolam
and morphine. In the last week and coinciding with the
discontinuation of the sedation, antipsychotic drugs were necessary
and he was administered haloperidol. The patient is currently
intubated with a tracheostomy tube and nasogastric tube. No central
venous catheters or arterial lines have been inserted. The patient
does not connect with his surroundings, he is calm, but he
continuously moves his arms and legs.
49. Scenario 2
A 16-year-old female patient with no history of pathology is admitted to
the PICU (private room) following ingestion of toxic substances and
alcohol and a fall from 5 metres. Subsequent imaging reveals a severe
head injury necessitating high-impact head trauma management, which
includes orotracheal intubation, mechanical ventilation, and a
combination of medical and surgical interventions spanning 10 days.
Over the past week, concurrent with the withdrawal of analgo-sedation
and the initiation of the weaning process, she has required
pharmacological intervention with chlorpromazine, diazepam, and
quetiapine to mitigate episodes of agitation and disorientation.
Presently she remains connected to mechanical ventilation through an
endotracheal tube, with parameters set at minimal levels. Additionally,
she is equipped with a nasogastric tube and a urinary catheter. While
central venous catheters and arterial catheters have not been inserted,
two peripheral venous catheters have been placed in the upper
extremities. The patient does not connect with her immediate
environment and oscillates between periods of agitation alternating and
moments of tranquillity.
48. Scenario 3
A 78-year-old female with a past medical history of diabetes mellitus
and virus-related liver cirrhosis, who was admitted to the ICU (private
room) 5 days ago with a diagnosis of hepatorenal syndrome. She has
an orotracheal tube connected to mechanical ventilation and a
peripheral intravenous central catheter (PICC), without the need to
administer vasoactive drugs. She was calm throughout the day shift
but during the night shift she presented acute confusion with lack of
attention (CAM-ICU positive), aggressiveness and she tried to get out
of bed. The nurse informed the doctor on call of the patient's clinical
status, who prescribes an antipsychotic drug. The patient continues to
be confused and has psychomotor agitation.
50. Scenario 3
A 12-year-old male patient with no history of pathology is admitted to the
PICU as a result of a moderate bronchospasm attack. He is equipped
with a peripheral venous catheter and a high concentration mask. Upon
admission, he is agitated and displays moderate effort during breathing.
In response, non-invasive mechanical ventilation is initiated, featuring
an inspiratory pressure of 12cmH2O, an expiratory pressure of
6cmH2O and a FiO2 of 35%. However, as a result of the patient's
agitation, the peripheral catheter becomes dislodged and the non-
invasive ventilation face mask experiences substantial leakage.
Consequently, a new intravenous device is introduced. The parents are
distressed by the situation. The attending paediatrician opts to abstain
from employing pharmacological interventions and instead endeavours
to reassure the patient.
Not included 51. Scenario 4
A 3-month-old female infant, born prematurely at 32 weeks of gestation
with a history of moderate bronchopulmonary dysplasia, necessitating a
tracheostomy for home respiratory management, is admitted to the
PICU presenting symptoms of vomiting, diarrhoea, water-electrolyte
imbalance and a Gorelick scale rating of 6, indicative of severe
dehydration. Upon admission, she has a 3.5 tracheostomy cannula with
an inflated balloon, remaining tethered to her home ventilator. She
receives a 4-litre oxygen intake and 35% FiO2 and is also equipped with
a urinary catheter, but it is not possible to perform blood tests or
peripheral catheter placement. After several attempts and employing
physical restraint, the procedure is performed successfully, and a
(Continues)
BOSCH ALCARAZ ET AL. 7
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
items of the questionnaire. Taking into account that Polit et al.
(2007)34 recommend involving a panel of 8–12 experts, eight nurses
(different from the six who collaborated in phase 1) participated in this
phase, scoring the relevance and wording of each item by means of a
Likert-type scale, with scores from 0 (not at all) to 4 (very). Once the
content validity of the instrument was established, a pilot test was
carried out in which another group of 10 nurses, with training in pae-
diatrics and with at least 5 years of experience in the management of
paediatric critical patients. The purpose was to confirm proper com-
prehension, categorization, and internal order of the items, as well as
to anticipate any resistance that potential respondents may have to fill
out the questionnaire and the time required to complete it32.
Phase 3: Psychometric evaluation.
Once the content validation process of the Paediatric Physical
Restraint-Theory of Planned Behaviour Questionnaire was completed,
the participating nurses from phases 1 and 2 were contacted so that
they could distribute it among the eligible PICU nurses at their hospi-
tals. Before participants filled out the questionnaire, they attended an
online training session in which we described the research objectives,
data collection procedure, questionnaire, and data collection docu-
ment. The sample size was determined taking into account that the
COSMIN recommendations suggest the inclusion of ≥100 patients.31
2.2.6 | Statistical analysis
The collected data were stored in a database created with Microsoft
Excel®, and patient privacy was preserved. For the management and
statistical analysis of all data, we used SPSS® version 23.0 software
(Armonk, NY: IBM Corp.).
The numerical variables were described using descriptive statis-
tics (mean, standard deviation, median and quartiles) and were
TABLE 1 (Continued)
Physical Restraint-Theory of Planned Behaviour Questionnaire items Paediatric versiona
catheter is placed in the right upper extremity. Intravenous rehydration
using serum therapy is initiated. However, 2 h after the start of this
treatment, the patient becomes agitated. The help of the parents is
requested in trying to calm the infant, but it is not very effective, and
the peripheral catheter and the tracheostomy cannula become
dislodged. The cannula is re-inserted without incident, and, after several
attempts, a new peripheral catheter is successfully inserted using
echocardiography. The patient continues to experience episodes of
agitation, heightening the risk of falls. The parents react with distress.
The attending paediatrician prescribes levopromazine drops to manage
the patient's agitation.
Not included 52. Scenario 5
A male neonate of 10 days is admitted from the emergency department,
presenting bronchiolitis. He is equipped with high-flow nasal goggles
delivering 8 litres of air per minute. Furthermore, a peripheral venous
catheter placed in the child's right hand. He displays signs of moderate
respiratory distress. Secretion aspiration is performed to acquire
specimens for subsequent microbiological culture. Subsequently, the
patient is subjected to non-invasive mechanical ventilation,
characterized by an inspiratory pressure of 10cmH2O, an expiratory
pressure of 5cmH2O and an FiO2 of 30%. Initially, the infant exhibits
agitation in response to the intervention. However, when the care team
stops handling him, he calms down and falls asleep with the assistance
of the parents.
Not included 53. Scenario 6
A 3-year-old female child, who has recently been extubated following
7 days of orotracheal intubation and invasive mechanical ventilation, is
currently managed with a right jugular central venous catheter featuring
two lumens. Additionally, she is equipped with a nasogastric tube and a
bladder catheter. She is receiving continuous administration of fentanyl
at 1mcg/kg/min, while diazepan drops have been discontinued. Within
hours of extubation, the patient manifests episodes of agitation, which
can be attributed to pharmacological withdrawal syndrome. A score of 8
on the Withdrawal Assessment Tool-1 (WAT-1) scale is recorded. The
parents are distressed because they have two more children, the father
has to work, and they lack childcare for the other children. For this
reason, the patient spends time alone in her cubicle.
aThe original Physical Restraint-Theory of Planned Behaviour Questionnaire was written and administered in Spanish and translated by a sworn translator
for publication in English. See Data S1 for the complete paediatric version of the scale, including instructions and scoring.
8 BOSCH ALCARAZ ET AL.
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
represented graphically using frequency histograms. Categorical vari-
ables were described in frequency tables with percentages and bar
graphs.
The content validity of the questionnaire was determined by cal-
culating the item level content validity index (I-CVI) and scale average
level content validity index (S/Ave-CVI), according to the recommen-
dations of Lynn (1986)35 and Polit and Tatano (2006).36 Values ≥0.8
were considered acceptable.
To establish construct validity, a confirmatory factor analysis of
all items was carried out to confirm that the structure corresponds to
the theory of planned behaviour model. The number of factors in the
instrument was determined using the comparative factor index (CFI
>0.90), the Tucker-Lewis index (TLI >0.90) and the root mean square
error of approximation (RMSEA <0.08). The adjustment indices were
considered satisfactory given the criteria established by Ullman
(2006).37 In addition, a goodness-of-fit analysis was carried out for
the latent factors, considering those raised in the original question-
naire, and the relationships between factors were established using
Spearman's correlation coefficient. Reliability was assessed
using Cronbach's alpha coefficient of each item, which was considered
valid >0.60.38 Finally, the validity of the criteria was established by
comparing the psychometric results obtained with those of the origi-
nal questionnaire. The results were considered statistically significant
with p ≤ .05.
2.2.7 | Ethical considerations
Prior to conducting the study, we obtained approval from the nursing
administration and the ethics and clinical research committees of the
five hospitals where the study was carried out. We also received
the authorization of the main author of the original questionnaire. This
research was performed according to the principles set out in the
Declaration of Helsinki and subsequent amendments (2009), as well
as those of the Belmont Report.
Participation in the study was voluntary, and participants in all
phases had sufficient information through oral and written informed
consent information. All the data were confidential and privacy was
preserved by assigning each participant a code for the statistical pro-
cessing of the data, as well as adhering to the principles set out in EU
Regulation 2016/679 of the European Parliament and of the Council
of April 27, 2016 on the protection of personal data and the free
movement of data “and Spain's Organic Law” Organic Law 3/2018 of
5 of December for the Protection of Personal Data and the Guarantee
of Digital Rights.
3 | RESULTS
3.1 | Sociodemographic and occupational
characteristics of the participants
A total of eight nurses participated in the content validation, with a
median age of 34.4 (IQR 25–52) years and a PICU experience of 14.5
(IQR 3–26) years. Content validity scores of the items between 0.75
and 1 were obtained, with an overall content validity index for the full
instrument of 0.96 out of 1. No problems emerged during the pilot
test and therefore the questionnaire was not modified before
phase 3.
A total of 230 paediatric nurses of the 268 that made up the total
population of eligible nurses at the five hospitals answered the ques-
tionnaire (phase 3), of which 87.7% (n = 201) were female with a
mean age of 35.56 ± 9.73 years and work experience in PICU of
10.54 ± 8.43 years (Table 2).
3.2 | Structure, content, and construct validity
The Paediatric Physical Restraint-Theory of Planned Behaviour Ques-
tionnaire is made up of four subscales (attitude, subjective norms, per-
ceived behavioural control, and intention) subdivided into 7 factors
and 51 items (File S1):
• Attitude subscale: 13 items (4 items that directly measure attitude
and 9 composite items corresponding to behavioural beliefs by
outcome value).
• Subjective norms subscale: 8 items (4 items that directly measure
subjective norms and 4 compound items corresponding to norma-
tive beliefs by motivation to comply).
• Perceived behavioural control: 7 items (3 items that directly mea-
sure perceived behavioural control and 4 composite items corre-
sponding to beliefs of control by the power of influence).
• Intention subscale: 6 clinical scenarios (items 48–53) that evaluate
the intention of nurses to apply PR.
After confirmatory factor analysis to determine the construct
validity of the 53 items initially included, we decided to eliminate the
composite item 36–42 because it had a factorial load of 0.05. At
the same time, we observed that the factorial load of the rest of the
items was close to or greater than 0.3, except for three items related
to behaviour beliefs (Table 3). This could be attributed to both posi-
tive and negative beliefs being evaluated. When establishing the
matrix of interrelationships between items and considering whether
the reliability of the factor would increase, we found that Cronbach's
alpha would increase slightly, and we, therefore, decided not to
remove the items from the instrument.
Adequate goodness-of-fit indices of the model related to the the-
ory of planned behaviour were observed (Table 4).
3.2.1 | Reliability
Internal consistency
The internal consistency for the attitude subscale obtained a Cron-
bach's Alpha of 0.80 to 0.73. For the subjective norms subscale inter-
nal consistency was 0.72 to 0.89. For the perceived behavioural
control subscale, it was from 0.80 to 0.73 and for the intention sub-
scale it was 0.75 (Table 5).
BOSCH ALCARAZ ET AL. 9
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Correlation between factors
The correlation between each of the factors that make up the instru-
ment was positive in all cases and significant, with the exception of
normative control beliefs and subjective norms and intention. Figure 1
shows a graphical representation of the structure of the Paediatric
Physical Restraint-Theory of Planned Behaviour Questionnaire. When
performing the multivariate analysis among all the main components
of the instrument, we observed that the model explained 42% of the
variance in intention of PICU nurses to use PR (Table 6).
4 | DISCUSSION
There are no other instruments that assess the intention of nurses to
apply PR in the paediatric context, so it has only been possible
to compare our results with those related to the original question-
naire. The use of PR in PICUs is not limited to a specific type of
patient or critical situation since it is associated with the age and non-
collaboration of the paediatric patient. Children usually do not under-
stand their clinical situation, which can lead them to view health pro-
fessionals' actions as hostile, causing them to feel fear and anxiety
and, sometimes, become agitated.10,14 For this reason, unlike the orig-
inal instrument, which is validated in intubated patients,9 our paediat-
ric version assesses the intention of nurses to apply PR in critically ill
children of any age and clinical situation. Because we wanted to
include the most common clinical situations for the use of PR in paedi-
atric critical patients, we expanded the last subscale of intention from
three to six clinical scenarios.9
The paediatric scale obtained Cronbach's alpha scores of 0.73 for
the attitude subscale, 0.78 for subjective norms, 0.69 for perceived
behavioural control, and 0.75 for intention. These scores are some-
what higher than those of the original questionnaire for three of the
four subscales, which were 0.81, 0.64, 0.68 and 0.60 respectively.9
The confirmatory factor analysis of the paediatric scale showed that it
is structured in seven factors with adequate goodness of fit. This con-
firms that the paediatric version is a valid and reliable instrument that
converges with the precepts raised in Ajzen's theory of planned
behaviour.21 In relation to the correlations between factors, lower
values were observed for normative control beliefs and subjective
norms and intention, unlike in the original instrument. In addition, in
the original instrument, the factor with the most weight was per-
ceived behavioural control, unlike in the paediatric version, in which it
was attitude, showing a significant relationship with behavioural
beliefs. This finding means that for paediatric nurses, considerations
about the safety of the patient and the professional shape attitudes
towards the use of PR. A possible explanation is that the difficulty of
inserting life support devices (e.g., venous catheters, endotracheal
tube, drains), whose accidental removal can cause serious complica-
tions,39 leads paediatric professionals to conclude that PR should be
used to increase patient safety.9,11,14 Finally, the intention to use PR
explained 42% of the variance in the paediatric version and a some-
what lower proportion in the original instrument (33%).9
The family is a key factor in the care of the paediatric critical
patient. When parents stay in the PICU throughout the day and
actively participate in the care of their child, anxiety is reduced both
for the parents and the child,40 which could reduce the use of PR. For
this reason, three items and some clinical situations described in the
intention subscale consider the presence and cooperation of
the patient's family.
TABLE 2 Sociodemographic and occupational characteristics of
the sample (n = 230).
Feature Value
Gendera
Female 201 (87.4%)
Male 28 (12.2%)
Missing 1 (0.4%)
Age (years)b 34.4 (25–52)
Experience as a PICU nurse (years)b 14.5 (3–26)
Highest academic qualificationa
4-year degree in nursing 119 (51.7%)
5-year degree 3 (1.3%)
Postgraduate/master's 71 (30.9%)
Official master's degree/nursing specialty 37 (16.1%)
Doctorate 0 (0%)
Type of employment contracta
Fixed term 111 (48.3%)
Full-time interim 55 (24%)
Part-time interim/weekends 3 (1.3%)
Temporary 51 (22.2%)
Other 8 (3.4%)
Missing 2 (0.8%)
Work shifta
Morning 40 (17.4%)
Afternoon 25 (10.9%)
12-hour daytime 22 (9.6%)
12-hour night-time 49 (21.3%)
Rotating 94 (40.9%)
Combination with care practicea
Care work only 173 (75.2%)
Teaching 35 (15.2%)
Research 5 (2.2%)
Teaching and research 15 (6.5%)
Management 2 (0.9%)
Specific training in physical restrainta
Yes 28 (12.2%)
No 199 (86.5%)
Missing 3 (1.3%)
aFrequency (percentage).
bMedian and interquartile range.
10 BOSCH ALCARAZ ET AL.
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Another key factor is analgo-sedation since it reduces the stress
of critically ill paediatric patients and facilitates nursing care and adap-
tation to mechanical ventilation. However, the prolonged use of
analgo-sedation entails a series of complications and side effects,
including withdrawal syndrome, with an overall incidence in some
studies of more than one-third of patients.14,41 Among the symptoms,
we find irritability, anxiety, tremors, insomnia, delirium, hallucinations,
and inconsolable crying41 which may lead, given the lack of patient
collaboration and the risk of accidental removal of health care devices,
to the use of PR. For this reason, it is essential that paediatric instru-
ments consider both the appropriate use of analgo-sedation and the
risk of withdrawal syndrome.
The Physical Restraint-Theory of Planned Behaviour question-
naire in clinical practice can help assess the intention to use PR in pae-
diatric care. Additionally, it can guide the development of quality
improvement plans through multi-component interventions to reduce
the use of PR and promote safe and high-quality care for critically ill
paediatric patients.
TABLE 3 Coefficients for each item within the corresponding factor of the questionnaire with the 7 factors.
Dimension
Attitude
towards
behaviour
Behavioural
belief 
 outcome
evaluation
Subjective
norms
Normative
belief 
 motivation
to comply
Perceived
behavioural
control
Control
belief 
 power
of control Intention
Item
Item 1 0.48
Item 2 0.63
Item 3 0.55
Item 4 0.59
Item 5–13 0.66
Item 6–14 0.65
Item 7–15 0.48
Item 8–16 0.31
Item 9–17 0.19
Item 10–18 0.19
Item 11–19 0.28
Item 12–20 0.17
Item 38–44 0.25
Item 21 0.49
Item 22 0.51
Item 23 0.29
Item 24 0.67
Item 25–29 0.83
Item 26–30 0.92
Item 27–31 0.87
Item 28–32 0.26
Item 33 0.70
Item 34 0.75
Item 35 0.45
Item 37–43 0.50
Item_39–45 0.78
Item_40–46 0.65
Item_41–47 0.34
Item 48: Scenario 1 0.44
Item 49: Scenario 2 0.52
Item 50: Scenario 3 0.27
Item: 51:Scenario 4 0.39
Item 52: Scenario 5 0.48
Item 53: Scenario 6 0.39
BOSCH ALCARAZ ET AL. 11
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
4.1 | Strengths and limitations
The two greatest strengths of this research are the rigorous process
by which we adapted the instrument and our multi-centre design.
Limitations include our use of convenience sampling and the fact that
reproducing the study would require specific training for participants
and researchers in the use and interpretation of the scale. It is also
important to note that responses may have been conditioned by
social desirability bias and participants' beliefs about the ethically
acceptable use of PR. Finally, we included eight experts to validate
the scale's content. Although Polit et al. (2007) suggest the inclusion
of a panel of 8–12 experts to establish the content validity of a scale
in the COSMIN Design Checklist, a number of 30–49 experts seems
appropriate. Therefore, this was another limitation of the study.
5 | CONCLUSION
The Paediatric Physical Restraint-Theory of Planned Behaviour Ques-
tionnaire is an instrument composed of seven factors and 51 items
that validly and reliably assesses the intention of paediatric nurses to
apply PR in PICUs. This is the first study to adapt and expand to the
paediatric context a questionnaire that measures this intention
through the theory of planned behaviour—a robust construct that has
been amply tested and validated in prior studies. Having this instru-
ment will help health centres move towards restraint-free care by
allowing managers to assess professionals' attitudes, beliefs, and
intentions around the use of PR in PICUs.
TABLE 5 Internal consistency according to the seven factors.
Factor
Cronbach's
alpha 95% CI
Attitude 0.73 0.68–0.78
Attitude towards behaviour 0.80 0.76–0.84
Behavioural belief 
 outcome
evaluation
0.73 0.67–0.78
Norms 0.78 0.73–0.82
Subjective norms 0.72 0.65–0.77
Normative belief 
 motivation to
comply
0.89 0.86–0.91
Control 0.69 0.63–0.75
Perceived behavioural control 0.80 0.75–0.84
Control belief 
 power of control 0.73 0.67–0.79
Intention 0.75 0.69–0.79
TABLE 4 Goodness-of-fit indices of the 7-factor paediatric
instrument.
Chi-square χ2 = 1989.15; GL = 506; p < .001
RMR 0.09
RMSEA 0.09
CFI 0.91
TLI 0.90
Abbreviations: CFI, comparative fit index; RMR, root mean square
residual; RMSEA, root mean square error of approximation; TLI, Tucker-
Lewis index.
F IGURE 1 Internal consistency and Pearson's R correlation between the 7 factors of the Paediatric Physical Restraint-Theory of Planned
Behaviour Questionnaire. r = Pearson's correlation.* The correlation is significant at 0.05 (bilateral). ** The correlation is significant at 0.001
(bilateral).
12 BOSCH ALCARAZ ET AL.
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
AUTHOR CONTRIBUTIONS
P.P-R; P.L-C; E.Z-P; J.C-A; J.M.G-P; S.B-H; S.G-D; M.A.S-R; C.E-L; G.
V-C and A.B-A made substantial contributions to the conception,
design, or acquisition, analysis and interpretation of data. M.M-A; S.G-
R; N.A-M; M.J.E-G; E.M-O; E.C-M; E.L-F; G.L-A; A.G-M; D.M-C; R.F-
L; M.M-F; A.M-G and M.S-O collaborated in the acquisition and inter-
pretation of data. All authors involved in drawing the manuscript,
revising it, and approve the final version.
ACKNOWLEDGEMENTS
We thank the hospitals and particularly nurses who participated in
this study.
DATA AVAILABILITY STATEMENT
Research data are not shared.
ETHICS STATEMENT
Prior to conducting the study, we obtained approval from the nursing
administration and the ethics and clinical research committees of the
five hospitals where the study was carried out: Sant Joan de Déu Chil-
dren's Hospital (ethical approval number: PIC-176-21; approved date:
04 November 2021); Vall d'Hebron Hospital (ethical approval number:
PR(AMI)07/2022; approved date: 28 January 2022); La Paz University
Hospital (ethical approval number: PI-5146; approved date: 10 Febru-
ary 2022); 12 October Hospital (ethical approval number: 22/016;
approved date: 17 January 2022) and Carlos Haya Regional University
Hospital (ethical ratification/acceptance of the coordinating centre
(Sant Joan de Déu Hospital) on 24 November 2021).
ORCID
Patricia Luna Castaño https://orcid.org/0000-0002-5317-5811
REFERENCES
1. Demir A. The use of physical restraints on children: practices and atti-
tudes of pediatric nurses in Turkey. Int Nurs Rev. 2007;17:367-374.
doi:10.1111/j.1466-7657.2007.00547.x
2. Dorfman P, Hardy M. The immobilization and restraint of pediatric
patients during plain film radiographic examinations. Radiography.
2004;10:23-31. doi:10.1016/j.radi.2004.01.002
3. Badia M, Vicario E, García Solanes L, Serviá L, Justes M, Trujillano J.
Atención del paciente crítico pediátrico en una UCI de adultos,
Utilidad del índice PIM. Med Intens. 2013;2013(37):83-90. doi:10.
1016/j.medin.2012.03.007
4. Dolz Alabau C, Martinez Dolz J, Soriano Prats MA. Contención física
y/o mecánica: plan terapéutico de seguridad en el paciente crítico pediá-
trico. Hospital Universitario Politécnico de la Fe de Valencia, Unidad
de Cuidados Intensivos Pediátricos; 2013. http://anecipn.org/pdf/
congresos/XXXIV/documentos/M23-4.pdf
5. Crutchfield P, Gibb TS, Redinger MJ, Ferman D, Livingstone J. The
conditions for ethical application of restraints. Chest. 2019;155:617-
625. doi:10.1016/j.chest.2018.12.005
6. Via Clavero G. Intención de usar contenciones mecánicas en las uni-
dades de cuidados intensivos: diseño y validación de un instrumento
y factores relacionados (Tesis doctoral). 2019. Barcelona: Universidad
de Barcelona. http://hdl.handle.net/10803/667920
7. Via Clavero G, Sanjuán Naváis M, Romero García M, de la Cueva
Ariza L, Martínez Estalella G, Plata Menchaca E, et al. Eliciting critical
care nurses’ beliefs regarding physical restraint use. Nursing Ethics.
2019;26:1458–1472. doi:10.1177/0969733017752547.
8. Zhang Y, Liu L, Hu J, et al. Assessing nursing quality in paediatric
intensive care units: a cross-sectional study in China. Nurs Crit Care.
2017;22:355-361. doi:10.1111/nicc.12246
9. Via Clavero G, Guàrdia Olmos J, Gallart Vivé E, Arias Rivera S, Casta-
nera Duro A, Delgado Hito P. Development and initial validation of a
Theory of Planned Behavior questionnaire to assess critical care
nurses’ intention to use physical restraints. J Adv Nurs. 2019;75:
2036-2049. doi:10.1111/jan.14046
10. Bosch Alcaraz A, Via Clavero G. Can we justify the use of physical
and mechanical restraint in pediatric patients admitted to the Inten-
sive Care Unit. Med Intens. 2020;44:192-195. doi:10.1016/j.medine.
2019.05.008
11. Moyano Hernández M. Sí a las contenciones mecánicas en las uni-
dades de Cuidados Intensivos Pediátricos. Tertulia Pro/contra. ¿Se
deben utilizar contenciones mecánicas? Libro de ponencias 33 Con-
greso Nacional de la Sociedad Española de Cuidados Intensivos
Pediátricos. Barcelona, Ergon. 2018. https://secip.com/wp-content/
uploads/2018706/12
12. Burry L, Rose L, Ricou B. Physical restraint: time to let go. Intensive
Care Med. 2018;44:1296-1298. doi:10.1007/s00134-017-5000-0
13. Devlin JW, Skrobik Y, Vice-chair F, et al. Clinical practice guidelines for
the prevention and Management of Pain, agitation / sedation, delirium,
immobility, and sleep disruption in adult patients in the ICU. Crit Care
Med. 2018;46:e825-e873. doi:10.1097/CCM.0000000000003299
14. Via Clavero G, Guàrdia Olmos J, Falcó Pegueroles A, Gil Castillejos D,
Lobo Cívico A, De La Cueva Ariza L, et al. Factors influencing critical
care nurses intentions to use physical restraints adopting the theory
of planned behaviour: A cross-sectional multicenter study. Austr Crit
Care. 2020;33:426-435. doi:10.1016/j.aucc.2019.09.003
15. De Hert M, Dirix N, Demunter H. Prevalence and correlations of
seclusion and restraint use in children and adolescents: a systematic
TABLE 6 Results of the multivariate analysis of the model.
Subscale Unstandardised β 95% CI Standardized β p-value
Attitude towards behaviour 0.42 0.22 to 0.62 0.27 <.001
Behavioural belief 
 outcome evaluation 0.03 0.02 to 0.05 0.32 <.001
Subjective norms 0.00 0.12 to 0.12 0.00 .99
Normative belief 
 motivation to comply 0.00 0.02 to 0.01 0.02 .66
Perceived behavioural control 0.23 0.08 to 0.38 0.16 .00
Control belief 
 power of control 0.07 0.02 to 0.11 0.16 .00
Abbreviations: β, beta coefficient; CI, confidence interval.
Note: Adjusted R2 coefficient of determination = 0.423.
BOSCH ALCARAZ ET AL. 13
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
review. Eur Child Adolesc Psychiatry. 2011;20:221-230. doi:10.1007/
s00787-011-0160-x
16. Lambrenos K, McArthur E. Introducing a clinical holding policy. Pae-
diatr Nurs. 2003;15:30-33. doi:10.7748/paed2003.05.15.4.30.c852
17. Jeffery K. Therapeutic restraint of children: it must be always justi-
fied. Paediatr Nurs. 2002;14:20-22. doi:10.7748/paed.14.9.20.s20
18. Brenner M. Child restraint in the acute setting of pediatric nursing: an
extraordinarily stressful event. Issues Compr Pediatr Nurs. 2007;30:
29-37. doi:10.1080/01460860701366658
19. Mion LC. Physical restraint in critical care settings: Physical restraint
in critical care settings: will they go away? Geriatr Nurs. 2008;29:421-
423. doi:10.1016/j.gerinurse.2008.09.006
20. Ofoegbu BN, Playfor SD. The use of physical restraints on paediatric
intensive care units. Pediatr Anesth. 2005;15:407-411. doi:10.1111/j.
1460-9592.2004.01551.x
21. Ajzen I. The theory of planned behavior: frequently asked questions.
Hum Behav Emerg Tech. 2020;2:314-324. doi:10.1002/hbe2.195
22. Ajzen I, Fishbein M. Understanding Attitudes and Predicting Social
Behaviour. Prentice Hall; 1980.
23. Fishbein M, Ajzen I. Belief, Attitude, Intention and Behaviour: an Intro-
ductory to Theory and Research. Addison-Wesley; 1975.
24. Godin G, Bélanger-Gravel A, Eccles M, Grimshaw J. Healthcare pro-
fessionals' intentions and behaviours: a systematic review of studies
based on social cognitive theories. Implement Sci. 2008;3:36. doi:10.
1186/1748-5908-3-36
25. Godin G, Kok G. The theory of planned behaviour: a review of its
applications to health-related behaviors. Am J Health Promot. 1996;
11:87-98. doi:10.4278/0890-1171-11.2.87
26. McEachan RRC, Conner M, Taylor NJ, Lawson RJ. Prospective
prediction of health-related behaviours with the theory of planned
behavior: a meta-analysis. Health Psychol Rev. 2011;5:97-144. doi:10.
1186/1748-5908-3-36
27. Eskandari F, Abdullah KL, Zainal NZ, Wong LP. Use of physical
restraint: Nurses' knowledge, attitude, intention and practice and
influencing factors. J Clin Nurs. 2017;26:4479-4488. doi:10.1111/
jocn.13778
28. Werner P, Mendelsson G. Nursing staff members' intentions to use phys-
ical restraints with older people: testing the theory of reasoned action.
J Adv Nurs. 2001;35:784-791. doi:10.1046/j.1365-2648.2001.01911.x
29. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC. Strength-
ening the reporting of observational studies in epidemiology
(STROBE): explanation and elaboration. Int J Surg. 2014;12:1495-
1499. doi:10.1016/j.ijsu.2014.07.014
30. Mokkink LB, Prinsen CAC, Bouter LM, de Vet HCW, Terwee CB. The
COnsensus-based standards for the selection of health measurement
INstruments (COSMIN) and how to select an outcome
measurement instrument. Braz J Phys Ther. 2016;20:105-113. doi:10.
1590/bjpt-rbf.2014.0143
31. Mokkink LB, Prinsen CAC, Patrick DL, et al. COSMIN study design
checklist for patient-reported outcome measurement instruments.
2019. https://www.cosmin.nl/wp-content/uploads/COSMIN-study-
designing-checklist_final.pdf
32. Ludwig B. Predicting the future: have you considered using the Del-
phi methodology? J Extens. 1997;35(5):35. http://www.joe.org/joe/
1997october/tt2.html
33. Polit D, Beck C. Essential of Nursing Research: Methods, Appraisal and
Utilization. 6th ed. Lippincott Williams and Wilkings; 2006.
34. Polit DF, Tatano Beck C, Owen SV. Is the CVI an acceptable indicator
of content validity? Appraisal and recommendations. Res Nurs Health.
2007;30:459-467. doi:10.1002/nur.20199
35. Lynn MR. Determination and quantification of content validity.
Nurs Res. 1986;35:382-385. doi:10.1097/00006199-198611000-
00017
36. Polit D, Tatano C. The content validity index: are you sure you know
what's being reported? Critique and recommendations. Res Nurs
Health. 2006;29:489-497. doi:10.1002/nur.20147
37. Ullman JB. Structural equation modeling: reviewing the basics and
moving forward. J Pers Assess. 2006;87:35-50. doi:10.1207/s153277
52jpa8701_03
38. Nunnally J, Bernstein I. Psychometric Theory. 3rd ed. McGraw-Hill;
1995.
39. Al-Abdwani R, Williams CB, Dunn C, et al. Incidence, outcomes and
outcome prediction of unplanned extubation in critically ill children:
an 11 year experience. J Crit Care. 2018;44:368-375. doi:10.1016/j.
jcrc.2017.12.017
40. Arona Olmo S, Rodriguez AM. La humanización de los cuidados enfer-
meros en unidades de críticos neonatales y pediátricos. Àgora de
Salut. 2022;8:189-203. doi:10.6035/AgoraSalut.2022.8.17
41. Fernández Carrión F, Pérez A. Síndrome de abstinencia en la UCIP
Protoc Diagnós Terapéut Pediatr. 2020;3:3-15. https://www.aeped.es/
sites/default/files/documentos/01_sindrome_ucip.pdf
SUPPORTING INFORMATION
Additional supporting information can be found online in the Support-
ing Information section at the end of this article.
How to cite this article: Bosch Alcaraz A, Piqueras
Rodríguez P, Corrionero Alegre J, et al. Adaptation and
validation of the Physical Restraint-Theory of Planned
Behaviour Questionnaire to the paediatric context. Nurs Crit
Care. 2024;1‐14. doi:10.1111/nicc.13066
14 BOSCH ALCARAZ ET AL.
 14785153, 0, D
ow
nloaded from
 https://onlinelibrary.w
iley.com
/doi/10.1111/nicc.13066 by Readcube (Labtiva Inc.), W
iley Online Library on [08/05/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on W
iley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License