Does Virtual Reality Technology Reduce Pain and Anxiety During Outpatient Hysteroscopy? A Randomised Controlled Trial
Phase: NA
Conditions: Anxiety, Pain
Sponsor: Imperial College Healthcare NHS Trust

 
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Does Virtual Reality Technology Reduce Pain and Anxiety During Outpatient 
Hysteroscopy? A Randomised Controlled Trial 
 
 
 
 
Version 2 
Date 14/02/22  
IRAS no 306610 
 
 
 
 
MAIN SPONSOR: Imperial College Healthcare NHS Trust  
FUNDERS: N/A 
NRES reference:  
 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Study Management Group 
 
Chief Investigator: Mr Stephen  Quinn  
 
 
Co-investigators: Mr Thomas Sewell  
 
Study Management: Mr Thomas Sewell  
 
 
Study Coordination Centre  
 
For general queries, supply of study documentation, and collection of data, please contact: 
 
Study Coordinator: Mr Thomas Sewell  
Address: Dept. of O&G, Ground Floor, Mint Wing, St Mary’s Hospital, South Wharf Road, 
Paddington, W2 1NY  
 
 
 
 
Registration: GMC  
E-mail:  thomas.sewell2@nhs.net 
 
 
 
 
 
 
 
 
Clinical Queries 
 
Clinical queries should be directed to Mr Thomas Sewell who will direct the query to the 
appropriate person 
 
 
Sponsor 
 
Imperial College Healthcare NHS Trust is the main research Sponsor for this study.  For 
further information regarding the sponsorship conditions, please contact the Head of 
Regulatory Compliance at: 
 
 
 
Joint Research Compliance Office 
Imperial College London & Imperial College Healthcare NHS Trust 
2nd Floor Medical School Building 
St Mary’s Hospital 
Praed Street 
London 
W2 1NY 
Tel: 020759 41862 
Imperial College – Research Governance and Integrity Team (RGIT) Website 
 
 
 
Funder: N/A 

 
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No funding required (VR headset loaned by Sync VR Medical). 
 
This protocol describes the virtual reality technology during outpatient hysteroscopy study and 
provides information about procedures for entering participants. .  Every care was taken in its 
drafting, but corrections or amendments may be necessary. These will be circulated to 
investigators in the study.  Problems relating to this study should be referred, in the first 
instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the UK Policy Frame Work for Health and 
Social Care Research. It will be conducted in compliance with the protocol, the Data Protection 
Act and other regulatory requirements as appropriate.  
   
 
Table of Contents 
1. 
INTRODUCTION 
5 
1.1 BACKGROUND 
5 
2.  STUDY OBJECTIVES 
6 
3.  STUDY DESIGN 
7 
3.1 STUDY OUTCOME MEASURES 
9 
4. 
PARTICIPANT ENTRY 
9 
4.1 PRE-REGISTRATION EVALUATIONS 
9 
4.2 INCLUSION CRITERIA 
9 
4.3 EXCLUSION CRITERIA 
9 
4.4 WITHDRAWAL CRITERIA 
9 
5. 
ADVERSE EVENTS 
10 
5.1 DEFINITIONS 
10 
5.3 REPORTING PROCEDURES 
10 
6. 
ASSESSMENT AND FOLLOW-UP 
11 
7. 
STATISTICS AND DATA ANALYSIS 
11 
8. 
REGULATORY ISSUES 
11 
8.1 ETHICS APPROVAL 
11 
8.2 CONSENT 
11 
8.3 CONFIDENTIALITY 
11 
8.4 INDEMNITY 
11 
8.5 SPONSOR 
12 
8.6 FUNDING 
12 
8.7 AUDITS AND INSPECTIONS 
12 
9. 
STUDY MANAGEMENT 
12 
10. 
PUBLICATION POLICY 
12 
11. 
REFERENCES 
12 

 
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12. 
APPENDICES 
12 
                                                                                      
 
GLOSSARY OF ABBREVIATIONS 
3D US  
Three dimensional Ultrasound  
VR 
Virtual reality   
OPH 
Outpatient Hysteroscopy  
NHS 
National Health Service  
 
KEYWORDS 
Virtual reality technology, outpatient hysteroscopy, pain, anxiety. Endometrial receptivity; 
endometrial receptivity array; mRNA expression; uterine fibroids; uterine septum; recurrent 
miscarriage; subfertility; implantation; window of implantation; metroplasty; myomectomy  
 
 
STUDY SUMMARY 
 
TITLE Does Virtual Reality Technology Reduce Pain and Anxiety During Outpatient 
Hysteroscopy? A Randomised Controlled Trial 
DESIGN Randomised controlled trial  
AIMS To evaluate whether the use of virtual reality technology can reduce pain and 
anxiety during outpatient hysteroscopy procedures.   
OUTCOME MEASURES Primary outcome measures are patient reported NRS (numeric rating score) for 
pain and anxiety.  
Secondary outcome measures will be length of procedure, complication rate, 
reported side effects, procedure completion or if stopped, hysteroscopy findings 
and type of procedure performed. 
POPULATION Women aged referred from general gynaecology clinics for outpatient hysteroscopy 
procedures.  
ELIGIBILITY Inclusion criteria are age 18-70, capacity to give informed consent and cognitive and 
linguistic ability sufficient to understand and fill out the NRS questionnaire. Exclusion 
criteria are epilepsy or severe vertigo, blindness or significant hearing impairment and 
recent facial injury/burn 
 
DURATION 1 year 
 
 
 
 
 
 
 
 
 

 
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1. 
INTRODUCTION  
 
1.1 
BACKGROUND 
 
 
Hysteroscopy is a very common gynaecological procedure where a camera attached to a thin 
scope is passed into the uterus via the vagina and cervix in order to obtain views of the inside 
of the uterus. Hysteroscopy is used for the diagnosis and management of a variety of benign 
and conditions as well as the diagnosis of uterine cancer.  It can be performed under general 
anaesthetic or in an outpatient setting without formal anaesthetic. The latter has several 
advantages when compared to hysteroscopy with general anaesthesia as it avoids the 
additional risk of general anaesthesia, has a quicker recovery time, shorter hospital stay and 
reduced cost. Outpatient hysteroscopy (OPH) is generally well tolerated although some 
women will experience significant pain and pain is one of the most common reasons for failure 
to complete the procedure. 
 
 
As pain is one of the leading reasons for procedure failure, finding ways to reduce pain and 
anxiety is of critical importance. The optimal method of controlling pain and anxiety during 
outpatient hysteroscopy is poorly understood and hotly debated.  Options include sedation, 
local anaesthetic, analgesics including paracetamol, non-steroidal anti-inflammatory 
medication, opioids, Entonox and various distraction techniques.  There is a wide variation of 
clinical practice between different units within the UK due to a paucity of good quality evidence 
informing best practice. Conventional therapy, as recommended by the Royal College of 
Obstetricians and Gynaecologists, involves the use of simple pain killers taken prior to the 
procedure and sometimes local anaesthetic during the procedure if dilatation of the cervix is 
required (RCOG 2011).  
 
Virtual reality (VR) technology is a relatively new and promising technology which if used as a 
distraction technique, may be able to reduce pain and anxiety experienced from a wide range 
of medical procedures. Virtual reality (VR) is a human–computer interface that provides users 
with various physical sensations (e.g., visual, haptic, auditory) to increase realism in the virtual 
world (Seth et al. 2011). This heightened sense of realism produces a phenomenon known as 
“presence,” which refers to the user’s authentic experience of being in the virtual world as a 
result of visual or auditory displays generated by a computer (Barfield and Hendrix 1995). VR’s 
ability to provide users with highly realistic immersive experiences can be used to for a variety 
of medical indications including distraction from uncomfortable or painful procedures.  
 
 
To date VR has been used in a wide variety of inpatient and outpatient clinical scenarios to 
reduce pain and anxiety including simple blood tests, ENT procedures and minor 
gynaecological procedures such as hysterosalpingograms (Chan et al 2018, Wang et al 2020 
and Ahmadpoura et al 2019).  However, currently, to the best of our knowledge, there is only 
one relatively small-scale trial investigating the use of VR in an outpatient hysteroscopy setting 
(Deo et al 2020) meaning further studies are urgently needed to clarify the situation.  
 
 
 
 
 
 
 
 
 

 
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1.2 
RATIONALE FOR CURRENT STUDY 
 
The purpose of this study would be to determine if the use of VR technology can reduce pain 
and anxiety experienced by patients during outpatient hysteroscopy procedures when compared 
to standard pain management.  
 
The optimal method of controlling pain and anxiety during outpatient hysteroscopy is poorly 
understood and there is a wide variation in clinical practice. This study aims to test whether 
VR technology could reduce pain and anxiety as a relatively simple and safe adjunct to 
conventional pain management. Although VR has been used in a variety of clinical settings to 
date, there is only one previous study investigating the use of VR in an outpatient hysteroscopy 
setting (Deo et al 2020). This existing trial established that the use of VR is feasible in the OPH 
setting and that it was effective with significant improvements in patient reported anxiety and 
pain scores compared to conventional pain management.  However, as the authors themselves 
acknowledge, it involved relatively small numbers (20 patients in control and intervention 
group respectively). The rationale of this study would be to build upon this evidence by 
performing the first large scale adequately powered randomised control trial of the use of VR 
technology in this setting.  
 
We hypothesise that the use of VR technology will significantly improve pain and anxiety 
when compared to conventional pain management. Finding additional low risk ways of 
improving pain and anxiety during OPH is of critical importance in order to improve patient 
experience and the success rate of the procedure as pain is a major reason for unsuccessful 
OPH procedures.  
 
 
 
2.  STUDY OBJECTIVES 
The primary objectives of this study are to determine if:  
1) VR technology can reduce pain during outpatient hysteroscopy? 
2) VR technology can reduce anxiety during outpatient hysteroscopy? 
 
The secondary objectives of this study are to determine if: 
 
1)   The use of VR technology feasible during outpatient hysteroscopy? 
 
    2) The use of VR during outpatient hysteroscopy reduces the procedure failure rate? 
 
3) The use of VR increases the outpatient hysteroscopy appointment time? 
 
 
 
 
 
 
 
 
 

 
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3.  STUDY DESIGN 
 
 
 
The study design is an unblinded randomised controlled trial. This study design was chosen as 
it will provide the best quality of evidence with reduced bias compared to other study designs. 
A randomised controlled trial is also very feasible in this scenario. Neither the researchers nor 
the participants will be blinded as to which study arm they are in, as it would be impractical to 
do so with a VR  headset used in the intervention group. The study will be adequately powered 
with a power calculation based upon findings from previous studies, meaning at least 40 
patients will be included in each arm (at least 80 patients in total).  
 
Patients will be randomly allocated by computer allocation to either the intervention or the 
control group. The intervention group will undergo OPH with standard care plus the use of VR 
technology administered through a headset with the option of wearing headphones (at the 
patient’s discretion) or having the accompanying sound played aloud. The control group will 
undergo outpatient hysteroscopy with standard care. Standard care in this unit is in line with 
the RGCOG guidelines and involves advising patients to take ibuprofen and/or paracetamol 
one hour prior to their procedure unless there are contraindications. Local anaesthetic 
intracervical block is used at the discretion of the operator and is usually used if dilatation of 
the cervix is required.  
 
The primary outcome measure will be the reported NRS (numeric rating score) score which is 
validated score to assess pain and anxiety levels with values from 0-11. The patient will be 
asked to fill out the NRS score prior to the hysteroscopy and following the hysteroscopy prior 
to leaving the clinic.  
 
Secondary outcome measures will be length of procedure, complication rate, reported side 
effects, procedure completion, hysteroscopy findings and type of procedure performed (for 
example if purely diagnostic or if any operative procedures are performed).   
 
Participants will be recruited from the general gynaecology clinics. Only patients who have 
already opted to undergo outpatient hysteroscopy will be invited to take part in the study and 
they will be made aware of the study at the time of the clinic appointment or shortly after. 
Interested parties will then be contacted by the research team to discuss the study in more detail 
at a time which is convenient for the patient. Written consent to enter the study will be sought 
from the participant in advance of their procedure and only after a full explanation has been 
given.  The patient will be offered a study information leaflet. Whilst waiting for their 
hysteroscopy procedure, the patient will be offered a face-to-face appointment with a member 
of the research team to discuss the study and sign the written consent form if they wish to 
participate in the study. If it is more convenient for the patient, and to avoid unnecessary 
additional appointments for the patient, they may prefer to discuss the study and go through 
the consent by phone before confirming consent on the day of the procedure.  Patients will have 
time to consider whether to take part in the study prior to their procedure day and will be 
informed that they can withdraw consent for participation in the study at any time. Participating 
or not participating in the study will have no effect on the timing of the outpatient hysteroscopy 
or the type of procedure performed.  Patients will have the opportunity to choose which virtual 
reality scenario they wish to experience during the procedure (choice of 4 scenarios from beach, 
space, underwater and zen four seasons).  

 
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At the time of their hysteroscopy. The patient will fill out the pre-procedure NRS score prior 
to entering the hysteroscopy room. The patient will then enter the outpatient hysteroscopy room 
where there will be the hysteroscopy team consisting of the lead hysteroscopist and the 
assistant, and also a single member of the research team who will have taken the study consent 
from the patient prior to their procedure. Following discussion with the hysteroscopist as usual, 
the patient will prepare for the procedure and position themselves on the procedure couch. 
Once comfortable, the member of the research team will help the patient to put on the VR 
headset (See appendix 1), and if the patient wishes, headphones. The virtual reality software 
will then start running and is controlled by the research team member, the software will run for 
the length of the procedure. The hysteroscopy team will be preparing the equipment as the 
virtual reality software is running. The member of the research team will remain in the room 
throughout the procedure to troubleshoot any issues with the headset or software and if 
necessary to stop the VR program. Following completion of the procedure the patient will fill 
out a NRS score prior to going home. 
 
The VR software involves breathing exercises, relaxing music and a distracting immersive 
walk through a virtual environment. The scenario will be started and subsequently controlled 
by a member of the research team operating a tablet device. The hysteroscopy team will 
perform the procedure in exactly the same way as they would normally and any clinical 
decisions regarding potential procedures such as polypectomy, discontinuing or proceeding 
with the hysteroscopy will be made by the hysteroscopy team along with the patient in the 
usual way without any input from the research team member.  
 
Maintaining appropriate clinical hygiene is of critical importance as the same headset will be 
used for different patients. The headset can be easily and effectively cleaned between use and 
the manufacturer (VR medical) provides a recommended cleaning regimen which we will use 
for the trial. After use, the VR device and controller should be cleaned with a damp microfibre 
cloth and disinfectant wipe, both the parts that have been in contact with the skin and the 
headbands. 
 
 
The timetable for the project is expected to run as follows. Three months for preparation and 
obtaining ethical approval. Recruitment is expected to start following this and we would expect 
to obtain the required number of participants by 3 months based on the average referral rate for 
outpatient hysteroscopy in the unit being 150 patients per month and a 20% study participation 
rate. Data analysis and preparing the final report would take a further 3 months. 
 
 
Results will be recorded onto a pseudoanonymised database. Information will be collected 
from patients notes and imaging reports. Each patient will be allocated a study number and 
for each the following will be recorded:  
Age  
Parity  
Symptoms and duration  
Past medical history and co-morbidities  
BMI 
Previous surgery  
Current medication and medication used within the last 6 months  
Pain NRS (numeric rating score)  
Anxiety NRS 

 
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Length of hysteroscopy procedure 
Time in Outpatient Procedure room 
Procedure successfully completed (or not) and reason for failure if appropriate 
Complications 
Hysteroscopy findings 
Type of hysteroscopic procedure performed 
 
 
 
3.1 
STUDY OUTCOME MEASURES 
The primary outcome measure will be the reported NRS (numeric rating score) score which is 
validated score to assess pain and anxiety levels with values from 0-11. The patient will be 
asked to fill out the NRS score prior to the hysteroscopy and following the hysteroscopy prior 
to leaving the clinic.  
 
Secondary outcome measures will be length of procedure, complication rate, reported side 
effects, procedure completion, hysteroscopy findings and type of procedure performed (for 
example if purely diagnostic or if any operative procedures are performed).   
 
 
4. 
PARTICIPANT ENTRY  
 
4.1 
PRE-REGISTRATION EVALUATIONS  
Women opting to undergo outpatient hysteroscopy 
 
4.2 
INCLUSION CRITERIA 
1. Age 18-70 
2. Patients undergoing outpatient hysteroscopy for any indication 
3. Capacity to give informed consent 
4. Cognitive and linguistic ability sufficient to understand and fill out the NRS questionnaire.  
 
 
4.3 
EXCLUSION CRITERIA 
1. Epilepsy 
2. Severe vertigo 
3. Significant hearing impairment 
4. Blindness 
5. Current facial injury /burn  
6. Patients who have not given informed consent 
7. Patients aged less than 18 or more than 70. 
 
 
4.4 
WITHDRAWAL CRITERIA 
 
Participant request  
 
 
 
5. 
ADVERSE EVENTS 
 

 
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5.1 
DEFINITIONS   
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect 
that: 
• 
Results in death 
• 
Is life-threatening – refers to an event in which the subject was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe 
 
• 
Requires 
hospitalisation, 
or 
prolongation 
of 
existing 
inpatients’ 
hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
 
Medical judgement should be exercised in deciding whether an AE is serious in other 
situations.  Important AEs that are not immediately life-threatening or do not result in death or 
hospitalisation but may jeopardise the subject or may require intervention to prevent one of 
the other outcomes listed in the definition above, should also be considered serious. 
 
5.3 
REPORTING PROCEDURES 
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.   
 
5.3.1 Non serious AEs 
All such events, whether expected or not, should be recorded.   
 
5.3.2 Serious AEs 
An SAE form should be completed and faxed to the Chief Investigator within 24 hours.   
 
All SAEs should be reported to the Greater Manchester East Research Ethics Committee 
where in the opinion of the Chief Investigator, the event was: 
• 
‘related’, i.e. resulted from the administration of any of the research procedures; 
and 
• 
‘unexpected’, i.e. an event that is not listed in the protocol as an expected 
occurrence 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP studies.  
The Chief Investigator must also notify the Sponsor of all related and unexpected SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
Contact details for reporting SAEs 
RGIT@imperial.ac.uk 
CI email (and contact details below) 
 
6. 
ASSESSMENT AND FOLLOW-UP  
 

 
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Definition of end of study: when final participant has been recruited within 1 year study 
period and has had filled out their post procedure NRS questionnaire. Incidental findings are 
not expected in this study. Any clinically relevant incidental findings that do occur during 
this study will be reported to the GP for ongoing care as necessary. 
 
 
7. 
STATISTICS AND DATA ANALYSIS 
 
Normally distributed data will be analysed using IBM SPSS software. Comparisons will be 
done with between intervention group and controls with a p value less than 0.05 used to 
indicate statistical significance.  
Means NRS scores will be compared between the 2 groups using the unpaired student's T 
test. 
Data and all appropriate documentation will be stored for a minimum of 5 years after the 
completion of the study, including the follow-up period.   
 
 
8. 
REGULATORY ISSUES 
 
8.1 
ETHICS APPROVAL 
The Study Coordination Centre has obtained approval from the Greater Manchester East 
Research Ethics Committee Research Ethics Committee (REC) and Health Research Authority 
(HRA). The study must also receive confirmation of capacity and capability from each 
participating NHS Trust before accepting participants into the study or any research activity is 
carried out. The study will be conducted in accordance with the recommendations for 
physicians involved in research on human subjects adopted by the 18th World Medical 
Assembly, Helsinki 1964 and later revisions. 
 
 
8.2 
CONSENT  
Consent to enter the study must be sought from each participant only after a full explanation 
has been given, an information leaflet offered and time allowed for consideration.  Signed 
participant consent should be obtained.  The right of the participant to refuse to participate 
without giving reasons must be respected.  After the participant has entered the study the 
clinician remains free to give alternative treatment to that specified in the protocol at any stage 
if he/she feels it is in the participant’s best interest, but the reasons for doing so should be 
recorded.  In these cases the participants remain within the study for the purposes of follow-up 
and data analysis.  All participants are free to withdraw at any time from the protocol treatment 
without giving reasons and without prejudicing further treatment. 
 
 
8.3 
CONFIDENTIALITY 
The Chief Investigator will preserve the confidentiality of participants taking part in the study 
and is registered under the Data Protection Act. 
 
Data will be psuedoanonymised.  
 
8.4 
INDEMNITY 
Imperial College Healthcare NHS Trust holds standard NHS Hospital Indemnity and 
insurance cover with NHS Resolution for NHS Trusts in England, which apply to this study. 
 

 
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8.5 
SPONSOR 
Imperial College Healthcare NHS Trust will act as the main Sponsor for this study.  
Delegated responsibilities will be assigned to the NHS trusts taking part in this study.   
 
8.6 
FUNDING 
No additional funding is necessary for this study. The VR device is being loaned by Sync VR 
Medical (Padualaan 8, 3584CH Utrecht Inc).  
  
8.7 
AUDITS  
The study may be subject to inspection and audit by Imperial College London under their remit 
as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS Research 
Governance Framework for Health and Social Care (2nd edition).  
 
 
9. 
STUDY MANAGEMENT 
 
The day-to-day management of the study will be co-ordinated through Mr Thomas Sewell.    
 
 
 
 
10. 
PUBLICATION POLICY 
Data from the study will be published in peer-reviewed publications as well as presented at 
national and international conferences. All data will be anonymised. 
 
 
11. 
REFERENCES 
 
1. Royal College of Obstetricians and Gynaecologists. Green Top Guideline No. 59: 
Best Practice in Outpatient Hysteroscopy.London: Royal College of Obstetricians and 
Gynaecologists; 2011. 
2. Seth, A., Vance, J.M. & Oliver, J.H. Virtual reality for assembly methods prototyping: 
a review. Virtual Reality 15, 5–20 (2011). https://doi.org/10.1007/s10055-009-0153-y 
3. Barfield, W., Hendrix, C. The effect of update rate on the sense of presence within 
virtual environments. Virtual Reality 1, 3–15 (1995). 
https://doi.org/10.1007/BF02009709 
4. Chan E, Foster S, Sambell R, Leong P. Clinical efficacy of virtual reality for acute 
procedural pain management: A systematic review and meta-analysis. PLoS One. 
2018 Jul 27;13(7): e0200987. doi: 10.1371/journal.pone.0200987. PMID: 30052655; 
PMCID: PMC6063420. 
5. Wang Y-L, Gao H-X, Wang J-S, Wang J-H, Bo L, Zhang T-T, et al. Immersive virtual 
reality as analgesia for women during hysterosalpingography: study protocol for a 
randomized controlled trial. Trials 2020;21:102. 
6. Ahmadpour N, Randall H, Choksi H, Gao A, Vaughan C, Poronnik P. Virtual Reality 
interventions for acute and chronic pain management. Int J Biochem Cell Biol. 2019 
Sep;114:105568. doi: 10.1016/j.biocel.2019.105568. Epub 2019 Jul 12. PMID: 
31306747. 
7. Deo N, Khan KS, Mak J, Allotey J, Gonzalez Carreras FJ, Fusari G, Benn J. Virtual reality 
for acute pain in outpatient hysteroscopy: a randomised controlled trial. BJOG. 2021 
Jan;128(1):87-95. doi: 10.1111/1471-0528.16377. Epub 2020 Jul 22. PMID: 32575151. 
 

 
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12. 
APPENDICES 
 
 
12.1 Appendix 1 VR headset and controller as supplied by Sync VR Healthcare.  
 
17.1 Figure VR  
left: VR headset top view, right: controller  
 
 
 
 
 
 
 
 
 
 
 
VR headset view from behind