Use of Virtual Reality (VR) in Pain and Anxiety Reduction in Inpatient Paediatric Venepuncture and Cannulation
Conditions: Pain, Fear, Child, Only
Sponsor: Manchester University NHS Foundation Trust

 
Virtual Reality for Pain and Anxiety in Children 
 
   
 
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Research Protocol V4, 30/06/2020. IRAS no 275354 
 
 
 
Use of Virtual Reality (VR) in pain and anxiety reduction in 
inpatient paediatric venepuncture and cannulation 
 
Protocol. Version 4, 30/06/2020 
IRAS Number: 
Sponsors reference number:  
275354 
B00823 
 
 

 
Virtual Reality for Pain and Anxiety in Children 
 
   
 
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The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to 
the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory 
requirement. 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the investigation without the prior written 
consent of the Sponsor 
I also confirm that I will make the findings of the study publicly available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent 
account of the study will be given; and that any discrepancies from the study as planned in this 
protocol will be explained. 
 
For and on behalf of the Study Sponsor: 
Signature:    
 
...................................................................................................... 
 
Date: 3006/2020 
Name (please print): 
Indi Banerjee 
 
 
Position:  
Consultant Paediatric Endocrinologist 
 
 
 
 
Chief Investigator: 
Signature:   
...................................................................................................... 
 
Date: 
30/06/2020 
Name: (please print): 
Indi Banerjee 
 
 
 
 
 
 
 
 
 
 

 
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LIST of CONTENTS 
GENERAL INFORMATION 
Page No. 
TITLE PAGE  
i 
RESEARCH REFERENCE NUMBERS 
 
i 
SIGNATURE PAGE 
ii 
LIST OF CONTENTS  
iii 
KEY STUDY CONTACTS 
iv 
STUDY SUMMARY 
iv 
FUNDING 
 
v 
ROLE OF SPONSOR AND FUNDER 
v 
ROLES & RESPONSIBILITIES OF STUDY STEERING GROUPS AND INDIVIDUALS   
v 
STUDY FLOW CHART 
 
viii 
SECTION  
1. BACKGROUND 
 
1 
2. RATIONALE 
 
2 
3. THEORETICAL FRAMEWORK 
2 
4. RESEARCH QUESTION/AIM(S)  
2 
5. STUDY DESIGN/METHODS 
2 
6. STUDY SETTING 
3 
7. SAMPLE AND RECRUITMENT 
3 
8. ETHICAL AND REGULATORY COMPLIANCE 
5 
9. DISSEMINATION  POLICY 
7 
10. REFERENCES 
7 
 
 

 
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KEY STUDY CONTACTS 
 
Chief Investigator 
Professor Indi Banerjee 
Indi.banerjee@mft.nhs.uk 
0044 161 701 1632 
Study Co-ordinator 
Dr Chris Worth 
Christophersimon.worth@mft.nhs.uk 
07837740913 
Sponsor 
Manchester University NHS Foundation Trust 
Oxford Road 
Manchester 
M13 9WL 
 
Funder(s) 
Manchester University NHS Foundation Trust 
Cobbett House 
Manchester Royal Infirmary 
Oxford Road 
Manchester 
M13 9WL 
Key Protocol Contributors 
Professor Indi Banerjee (as above) 
Dr Chris Worth (as above) 
Dr Tony Payton 
Tony.Payton@manchester.ac.uk 0161 2755714 
 
STUDY SUMMARY 
It may be useful to include a brief synopsis of the study for quick reference. Complete information and, 
if required, add additional rows. 
 
Study Title 
Virtual Reality for Pain and Anxiety in Children 
Internal ref. no. (or short title) 
B00823 
Study Design 
Feasibility/Acceptability study 
Study Participants 
Children aged 5-13 years who require cannulation or 
venepuncture as an inpatient 
Planned Size of Sample (if applicable) 32 
Follow up duration (if applicable) 
None 
Planned Study Period 
4 weeks 
Research Question/Aim(s) 
 
• 
Conduct initial acceptability/feasibility testing of VRH use 
with children undergoing venepuncture or cannulation in an 
acute, often unplanned inpatient setting in a children’s 
hospital. 
• 
Assess level of child and parent reported pain during 
procedure as well as change in heart rate. 

 
Virtual Reality for Pain and Anxiety in Children 
 
   
 
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• 
Generate pilot data to design software and develop methods, 
outcome measures and patient/family engagement for a 
large randomised control trial (RCT) in the same setting to 
establish efficacy of VRH in reduction of perceived pain.  
 
 
 
FUNDING AND SUPPORT IN KIND 
FUNDER(S) 
(Names and contact details of ALL organisations 
providing funding and/or support in kind for this 
study) 
FINANCIAL AND NON FINANCIALSUPPORT 
GIVEN 
Manchester University NHS Foundation Trust 
Contact details as above 
£9380 
VREvo 
Contact details as above 
Non-financial advice and support given in 
planning of study and in use of Virtual Reality 
Headsets.  
 
 
ROLE OF STUDY SPONSOR AND FUNDER 
Manchester Foundation Trust are the main sponsor. They will have joint responsibility with the study 
team for the design, conduct and management of the study. The study team will perform data 
interpretation and analysis and then write the manuscript. They will take responsibility for submission 
of the manuscript for publication dissemination of results. They will take responsibility for the planning 
of follow up studies. They and not the funder will control all final decisions over the study. 
 
VREvo are a Virtual Reality Education company part owned by the University of Manchester. They 
were involved in the planning of the study and will aid in the use of the technology during the study. 
They have provided training on how to use the technology. They will be involved in drafting the final 
manuscript and planning any follow up studies.  
 
ROLES AND RESPONSIBILITIES OF STUDY MANAGEMENT COMMITEES/GROUPS & 
INDIVIDUALS 
 
Patient & Public Involvement Group 
The study has been designed after taking feedback from 330 people in the University of Manchester, 
of whom 80% were medical and university students. To help with the study, a 12-year-old female and 
a 10-year old male were specifically asked to help with the design, questions and further feedback. 
The parents of these children were also invited for comments and suggestions. 
 

 
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PROTOCOL CONTRIBUTORS 
Professor Indi Banerjee – Consultant paediatric endocrinologist. Chief Investigator. Oversight of and 
involvement in the design, conduct, data analysis and interpretation, manuscript writing, and 
dissemination of results. 
Dr Chris Worth – Research fellow in paediatric endocrinology. Study co-ordinator. Primary 
responsibility for design, conduct, data analysis and interpretation, manuscript writing, and 
dissemination of results. 
Dr Anthony Payton – Senior Lecturer in Healthcare Sciences, i3HS lead, VREvo CEO. Involved in 
design, conduct, data analysis and interpretation, manuscript writing, and dissemination of results. 
As discussed above, children and their families were involved in the design of this study and pilot 
studies testing use of VRHs.  
 
KEY WORDS: 
Virtual Reality 
Painful Procedures 
Anxiety 
Pain 
Children 
Feasibility 
 

 
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STUDY FLOW CHART 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patients identified 
as requiring 
venepuncture or 
cannulation. 
Clinician performing 
procedure contacts 
study team. 
Parents and 
clinician complete 
acceptability 
questionnaires. 
Painful procedure 
performed by 
clinician. VRH 
supervised by parent. 
Study co-ordinator 
attends to explain study, 
answer questions and 
gain consent. 
Patient scores 
current pain and 
VRH and Fitbit are 
attached. 
VRH removed 
from patient. 
Patient scores pain 
and completes 
acceptability 
questionnaire. 
Questionnaires 
analysed and 
interpreted by 
research team. 

 
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STUDY PROTOCOL 
Virtual Reality for Pain and Anxiety in Painful Procedures 
1 
BACKGROUND 
Virtual reality (VR) technology is making rapid progress into many aspects of daily life and work and the 
potential applications within the field of medicine are huge, particularly amongst the paediatric 
population.  
 
Venepuncture and cannulation are common procedures in paediatrics and, despite developments in 
analgesic sprays and creams, it remains a procedure most children dread and which is uniquely 
distressing to patients, families and clinicians alike. Even children who undergo regular venepuncture 
often find this distressing. A lot of the pain and fear associated with venepuncture is psychological and 
secondary to the fact that most children become apprehensive before and distressed during the process. 
The sight of doctors, nurses, clinical environments and apparatus required for cannulation/venepuncture 
is frightening to young children. Distraction is very effective in reducing pain and anxiety in paediatric 
procedural pain1 but requires multiple members of skilled staff, cooperative, engaged parents and the 
time to coordinate all of this.  
 
The immersive nature of wearing a Virtual Reality Headset (VRH) in an outpatient or emergency 
department setting provides a very effective distraction to children, reducing the anxiety and pain 
associated with venepuncture and cannulation2. A number of studies have explored the application of 
VRH in children and young people and reported promising early outcomes. However, as these studies 
are variable in design, software application, setting and cultural context, it is not possible to extrapolate 
acceptability, satisfaction and positive gain between groups tested for VRH utility. There have been no 
VRH studies in children in the UK and no studies have evaluated the application in inpatient children 
with complex disease. 
 
In the University of Manchester, our group has engaged with children to assess feasibility of use and 
acceptability of different VRHs. VRHs were very well received and the Oculus Go was felt to be an 
appropriate size and fit for children aged 5 to 13 years. Initial and qualitative feedback has been 
overwhelmingly positive with 96% of over 300 people surveyed expressing enthusiasm about the use 
of VRHs.  
 
The majority of venepuncture and cannulation occurs in an inpatient setting and therefore often with 
minimal prior notice due to staff availability and the transient nature of cannulae in small children. This 
means that additional staff support for distraction is often not available during the day and almost never 
out of hours in busy hospitals with a stretched workforce. As children become older they are more aware 
of the hospital and often become more anxious and less easily distracted by standard play distraction 
techniques.  The use of a VRH could be easily employed at short notice by a single practitioner when 
venepuncture/cannulation is required and support staff are not available for distraction. Parents can be 
left to supervise their child using the VRH while clinicians focus on the clinical procedure. No studies 
have investigated the feasibility and acceptability of VRH use in a paediatric inpatient setting in a busy 
Children’s Hospital where distraction is often required at short notice. 
 
1Ali, PediatrEmergCare, 2016 
2Chan, JPediatr, 2019 
 
2 
RATIONALE  
We want to know if it is feasible to use VRH for distraction during painful procedures in paediatric 
inpatients. Utility of this cannot be extrapolated fromoutpatient/clinic/emergency department studies. 

 
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We want to know if this is acceptable to patients, parents and clinicians and if they would be keen for 
this to become routine practice for painful procedures in our hospital.  
 
Painful procedures are a source of significant stress and anxiety to children who are inpatients in 
hospital and it is our duty as clinicians to understand if there is a way in which we can reduce this 
stress and anxiety.  
If use of VRHs during painful procedures was found to be simple, effective and desirable this could be 
easily and quickly rolled out to all of our inpatient wards and later to other hospitals. This could have a 
significant impact upon the inpatient stay of children all over the country.  
 
This project will be conducted in accordance with the study protocol and the ethical principles outlined 
by Good Clinical Practice (GCP) and the Declaration of Helsinki in its most current version. 
 
3 
THEORETICAL FRAMEWORK 
The above approach is entirely appropriate to answer our research question. As there have been no 
studies using VRHs for painful procedures in children who are inpatients before, it would be 
inappropriate to conduct a randomised controlled trial looking in to relative pain and anxiety reduction 
without first conducting feasibility and acceptability trials. This is why we have chosen the above 
approach. This study will directly answer our study questions.  
 
4 
RESEARCH QUESTION/AIM(S) 
 
4.1 
Objectives 
 
1. Conduct initial acceptability/feasibility testing of VRH use with children undergoing venepuncture 
or cannulation in an acute, often unplanned inpatient setting in a children’s hospital. 
2. Assess level of child and parent reported pain during procedure as well as change in heart rate. 
3. Generate pilot data to design software and develop methods, outcome measures and 
patient/family engagement for a large randomised control trial (RCT) in the same setting to 
establish efficacy of VRH in reduction of perceived pain.  
 
4.2 
Outcome 
1. 
Perceived and reported pain/anxiety scores for children undergoing venepuncture or 
cannulation with VRH. 
2. 
Change in heart rate before, during and after painful procedure  
3. 
Clinicians’ feedback on the use of VRH in inpatient painful procedures 
 
 

 
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5 
STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYIS 
Practitioners will be encouraged to contact the research team each time they are to perform a procedure 
between 0830H and 1600H and, unless already with another child using VRH, the research team will 
come to speak to parents to consent to the study. If consent is obtained then the procedure will be 
performed using current standard care as well as use of a VRH. The Oculus Go is a cheap and quick to 
set up headset. Off the shelf software will be selected that will distract but not require the movement of 
both arms. Software such as The Blu, Ocean Rift and Pet lab will be selected, dependent upon the age 
of the patient. 
 
VRH will be brought to the room planned for procedure and set up for the child as part of the preparation 
for venepuncture/cannulation. Prior to application of VRH children will be asked to score their current 
pain score using the Wong Baker Faces Score (WBFS)1. This will be transcribed by the researcher. 
VRH use will be commenced at least 3 minutes prior to commencement of painful procedure. The 
procedure will then be performed by the practitioner and VRH supervised by parent(s). The researcher 
will not participate in the procedure beyond initial setup of the VRH to ensure real world feasibility is 
being tested for. Once the procedure is completed, the child will be allowed to continue using the VRH 
while clinicians and parents involved in the procedure fill in the feedback forms.  
 
Feedback forms for parents will focus on perceived pain score and short qualitative review regarding 
acceptability, whether they would consider repeat application at subsequent venepuncture procedures, 
if VRH was well tolerated and whether they felt it helped. Feedback from clinicians will focus on ease of 
use of VRH, if they felt it facilitated procedure or whether it was felt to prolong the procedure. Forms will 
be filled in by parents and clinicians themselves and then handed to the researcher.  
 
Children will then have the VRH removed and be asked to score their current pain again using the 
WBFS. Children’s WBFS will be compared pre and post procedure. Assessment of 
acceptability/feasibility for children will be based on 3 questions – 1. Do they like it, 2. Was VRH wear 
comfortable and 3. Did they feel unwell whilst wearing VRH. Questionnaire answers will also be used to 
design future trials and bespoke VR software.  
 
Questionnaires will then be pseudonymised and transcribed on to a secure computer for analysis of 
data. Interpretation of data will be performed by the clinical research team. Any statistical analysis 
required will be performed using SPSS Statistics 25 on pseydonymised datasets. Paper questionnaires 
will be kept in a locked drawer, in a locked room, on a locked research unit where access is only via 
swipe card. Access to paper questionnaires and digital data will only be for the immediate clinical 
research team of Professor Banerjee and Dr Worth.  
 
1 Wong-Baker FACES Foundation (2018). Wong-Baker FACES® Pain Rating Scale. Retrieved 
[11/10/19}] with permission from http://www.WongBakerFACES.org 
 
6 
STUDY SETTING 
The study will be performed on all paediatric inpatient wards at Royal Manchester Hospital. The 
research team will be based on the CCRF (Children’s Clinical Research Facility) and will move to each 
ward as required to provide VRH for procedures. Participants will be accessed via identification by 
clinicians performing painful procedures.  
Royal Manchester Children’s Hospital is the busiest children’s hospital in the UK. Venepuncture and 
cannulation are routinely performed by a wide variety of staff including doctors, nurses and the IV 
access team. It is therefore an ideal location to conduct this study. Participants will undergo 
recruitment, discussion with the research team, consent and procedure all in the same location within 

 
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Royal Manchester Children’s Hospital. Participation in the study will not impact upon patient care and 
will not require patients or parents to move anywhere or do anything they would not already be doing 
as part of their inpatient stay.  
 
7 
SAMPLE AND RECRUITMENT 
7.1  
Eligibility Criteria 
 
7.1.1 Inclusion criteria  
Any child of age 5-12 years who are an inpatient in Royal Manchester Children's Hospital over a 4 
week study period will be considered for consent if they require venepuncture or cannulation for a 
medical reason as determined by their lead medical team. 
 
All individuals will be considered for inclusion in this study regardless of age, disability, gender 
reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, 
and sexual orientation except where the study inclusion and exclusion criteria EXPLICITLY state 
otherwise. 
 
7.1.2 Exclusion criteria  
Children under the age of 5 years (may not fit the headset, may become upset) and over the age of 12 
years (pubertal, more mature understanding and expectations) will be excluded. 
 
Children not needed venepuncture or cannulation will not be invited. 
 
Children who have worn VRH previously and recognise dizziness/sickness or other ill health 
symptoms will not be asked to consent. 
 
Parent/ guardians of children who are unsure about VRH will be excluded.  
 
Parents will not be excluded if their first language is not English. As far as possible a translator will be 
arranged to translate child/parent responses and give feedback. 
 
7.2  
Sampling 
 
7.2.1  Size of sample 
For this feasibility study, we aim to recruit 32 children during a 4 week period. Using the primary outcome 
acceptability of patient use, 32 children will enable us to identify our acceptability target of 75% of patients 
with 95% CI 56.6-88.5% (Clopper-Pearson exact). This number will also provide meaningful 
representation of a spread of gender, age groups, complexity of underlying illness, cultural and ethnic 
backgrounds to design future studies. 
7.2.2  Sampling technique 
All children who are identified as eligible by clinicians will be considered for the study. If they meet the 
inclusion criteria and consent to the study they will be included. As this is purely a feasibility study no 
sampling technique beyond this will be required.  
7.3 
 Recruitment 

 
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The study will be advertised a month and two weeks prior to the start via email targeting all doctors, IV 
practitioners and nurses within Royal Manchester Children’s Hospital informing them of the availability 
of VRH headsets for distraction during venepuncture/cannulation. Posters detailing similar information 
will be distributed across all paediatric wards and in treatment rooms. Information will also be available 
on the trust intranet.  
 
7.3.1 Sample identification 
Clinicians who regularly undertake venipuncture and cannulation in the hospital will be made aware of 
the study two weeks ahead of the beginning of data collection via posters and emails. Clinicians will 
be responsible for informing the research team of eligible patients for the study. All patients who meet 
the eligibility criteria and are highlighted to the research team will be included.  
 
7.3.2 Consent 
Informed consent will be taken from parents of patients recruited to the study. Both patients and 
parents will be given a written information sheet to read prior to consent. Once they have read this 
they will have the opportunity to ask any questions of the research team. If they agree to take part 
then parents will be asked to sign a consent form. Children will be given the option to sign an assent 
form if they wish but this will not be compulsory.  
 
8 
ETHICAL AND REGULATORY CONSIDERATIONS 
8.1 
Assessment and management of risk 
Some children may not prefer to keep the Virtual Reality Headsets over their faces. They may also 
feel dizzy and be sick. If so, the headsets will be immediately removed and not re-applied. The child 
will continue to have the routine procedure without application of VRH. 
If parents or children are uncomfortable with the application of technology, they will not be consented 
and VRH will not be applied. 
8.2  
 Research Ethics Committee (REC) and other Regulatory review & reports 
• 
Before the start of the study, a favourable opinion will be sought from the Research 
Ethics Committee( REC) and Health Research Authority (HRA)  
Regulatory Review & Compliance  
• 
Before we enrol patients into the study, the Chief Investigator will ensure that 
appropriate approvals from participating organisations are in place. 
• 
For any amendment to the study, the Chief Investigator or designee, in agreement with 
the sponsor will submit information to the appropriate body in order for them to issue 
approval for the amendment. The Chief Investigator or designee will work with  the 
R&D department) so they can put the necessary arrangements in place to implement 
the amendment to confirm their support for the study as amended. 
• 
The study will be subject to the annual Self-Assessment questionnaire, for completion 
by a member of the research team 
Amendments  

 
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If amendments to the protocol are required, this will be determined by the Chief Investigator who will be 
ultimately responsible for this. This will be discussed with the Sponsor before submission to the ethics 
committee  
8.3  
Peer review 
The study protocol has been reviewed by the funder who are Manchester University NHS Foundation 
Trust.  The process for funding approval involved an independent peer review by at least two experts. 
This review was part of the application for funding under the DiTA funding offered by Manchester 
University NHS Foundation Trust.  
 
 
8.5 
Protocol compliance  
One of the strengths of our protocol is its simplicity and this will significantly improve compliance. 
Accidental protocol deviations can happen at any time and in this circumstance it would be reported 
immediately to the Chief Investigator and Sponsor. Any recurrent deviations from the protocol will not be 
considered acceptable and will be actioned immediately.  
 
8.6 
Data protection and patient confidentiality  
Only the direct clinical care team will have access to the patients' personal data. The research team 
(comprising of doctors in the Children's hospital) will not review medical/surgical data for the patient as 
this is irrelevant to the study and will contravene Data Protection and Confidentiality regulations as per 
standard clinical practice.  
The study data will be analysed by our research fellow at the Royal Manchester Children's Hospital. 
The results will be discussed with the senior statistician who is also based in the same NHS Trust. 
Data will be stored in the department of Paediatric Endocrinology at the Royal Manchester Children's 
hospital, on a departmental server kept secured by username and passwords. Access to the 
department is swipe card controlled and the room where the NHS computers with departmental drives 
are based is secured by a combination lock. Storage of research data will be overseen by the 
research team. Paper data will be stored in fire proof filing cabinets and kept under lock and key. 
Storage and destruction of research data will be carried out in line with trust archiving policies  
This is a feasibility and pilot study upon which a formal clinical trial will be launched. While this is an 
intervention related study, the primary aim is feasibility and applicability rather than efficacy. 
The data custodian is the Chief Investigator.  
 
8.7 
Indemnity 
NHS indemnity applies as this is a trust sponsored study. 
Equipment will be purchased using funding money and will be stored securely. There is no insurance in 
place for damage or loss to the equipment but this is considered to be very unlikely. If equipment was lost 
or damaged then replacement equipment could be borrowed from VREvo so as to allow completion of 
the study.  
 
8.8 
Access to the final study dataset 

 
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Research will not be registered on a public database and data will be kept locally. Identifiable personal 
data will only used at the time of the venepuncture/cannulation procedure and will not be used at any 
other time. We will pseudonymise data for analysis and anonymise data when sharing with the 
statistician, thereby breaking the link between patient identity and relevant data. Publication of data 
will only include high level outcomes with no patient identifiable information. The only people with 
access to the original data will be Professor Banerjee and Dr Worth. Pseudoanonymised data will be 
shared with the statistician.  
 
Parents and children will be asked to contact the research team by e-mail to arrange separate 
occasions to discuss results. As the study does not collect patient identifiable information the research 
team will be unable to contact the family after acquisition of data. 
 
The study team will prepare a manuscript with the final study results and this will be submitted to a 
peer review journal for publication and subsequent dissemination of results.  
 
 
9 
DISSEMINIATION POLICY 
9.1  
Dissemination policy 
Study data will be written up as a manuscript and submitted to a peer review journal for publication. 
Ownership of the data will rest with the main sponsor.  
 
10 
REFERENCES 
Ali S et al. An evidence based approach to minimizing acute procedural pain in the emergency 
department and beyond. Pediatr Emerg Care. 2016. 32 (1):36-42 
Chan E et al. Virtual Reality for pediatric needle procedural pain: two randomized clinical trials. J 
Pediatr. 2019. 209: 160-167.