Virtual Reality as a Distraction Technique for Management of Acute Pain at Outpatient Hysteroscopy.
Phase: NA
Conditions: Acute Pain, Hysteroscopy
Sponsor: Imperial College London

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Virtual Reality as a Distraction technique for management of acute pain at 
Outpatient Hysteroscopy. 
 
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MAIN SPONSOR: Imperial College London 
FUNDERS: not applicable 
STUDY COORDINATION CENTRE: Whipps Cross Hospital, Leytonstone, London, E11 1NR, 
Health NHS Trust 
IRAS Number: 245511 
 
 
Protocol authorised by: 
 
Name & Role 
Date 
Signature 
Mr Raj Rai 
 
26/3/18 
 
 
 
 
Study Management Group 
 
Chief Investigator: Mr Raj Rai 
 
Co-investigators:  
  
Nandita Deo (PI) 
Jonathan Benn,  
 
 
 
 
Gianopaulo Fusari 
 
 
 
 
Philip Pratt 
 
Statistician: Research team 
 
Study Management: Nandita Deo, PI 
 
 
Study Coordination Centre Imperial College London 

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For general queries, supply of study documentation, and collection of data, please 
contact: 
 
Study Coordinator: Ms Nandita Deo 
Address: Department of Obstetrics and Gynaecology, Whipps Cross University 
Hospital, London, E11 1NR 
nandita.deo@gmail.com 
Tel: 07939360357   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Queries 
 
Clinical queries should be directed to Ms Nandita Deo, Consultant Obstetrician and 
Gynaecologist, Whipps Cross Hospital, London, who will direct the query to the 
appropriate person. 
 
 
Sponsor 
 
Imperial College London 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 
 

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Funder 
 
There is no funder for the study as it is an MSc project 
 
This protocol describes ‘Virtual Reality as a Distraction technique for management of 
acute pain at outpatient hysteroscopy’ and provides information about the 
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 NHS Research Governance 
Framework for Health and Social Care (2nd edition). It will be conducted in 
compliance with the protocol, the Data Protection Act and other regulatory 
requirements as appropriate.  
 
Table of Contents 
1. 
INTRODUCTION 
6 
1.1 BACKGROUND 
6 
2.  STUDY OBJECTIVES 
10 
3.  STUDY DESIGN 
10 
3.1 STUDY OUTCOME MEASURES 
12 
4. 
PARTICIPANT ENTRY 
12 
4.1 PRE-REGISTRATION EVALUATIONS 
12 
4.2 INCLUSION CRITERIA 
12 
4.3 EXCLUSION CRITERIA 
12 
4.4 WITHDRAWAL CRITERIA 
12 
5. 
ADVERSE EVENTS 
12 
5.1 DEFINITIONS 
13 

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5.3 REPORTING PROCEDURES 
13 
6. 
ASSESSMENT AND FOLLOW-UP 
14 
7. 
STATISTICS AND DATA ANALYSIS 
16 
8. 
REGULATORY ISSUES 
16 
8.1 ETHICS APPROVAL 
17 
8.2 CONSENT 
17 
8.3 CONFIDENTIALITY 
17 
8.4 INDEMNITY 
18 
8.5 SPONSOR 
18 
8.6 FUNDING 
18 
8.7 AUDITS AND INSPECTIONS 
18 
9. 
STUDY MANAGEMENT 
18 
11. 
PUBLICATION POLICY 
18 
12. 
REFERENCES 
19 
EXAMPLE APPENDICES 
21 
APPENDIX 1. SUMMARY 
OF 
INVESTIGATIONS, 
TREATMENT 
AND 
ASSESSMENTS 
ERROR! BOOKMARK NOT DEFINED. 
 
GLOSSARY OF ABBREVIATIONS 
OPH 
Outpatient Hysteroscopy 
VR 
Virtual Reality 
 
 
 
 
 
KEYWORDS 
Distraction techniques 
Acute pain 
Outpatient Hysteroscopy 

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Virtual reality 
 
STUDY SUMMARY 
 
TITLE 
Virtual Reality as a Distraction technique for management of acute pain at 
Outpatient Hysteroscopy 
DESIGN 
Randomised Control Trial with Mixed methods – Qualitative and 
quantitative  
AIMS 
To study the role of distraction techniques for management of acute pain 
in Outpatient Hysteroscopy and to assess feasibility of using Virtual 
Reality for managing pain. 
 
OUTCOME 
MEASURES: 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
Primary objective:  
• Feasibility of using virtual reality as a distraction technique in 
management of acute pain in patients undergoing Outpatient 
Hysteroscopy.  
 
Secondary objectives:  
• Understanding 
the 
acceptability 
and 
effectiveness 
of 
VR 
interventions within the procedural groups and how these might 
vary as a function of different patient demographics.  
• Understanding the factors that might influence the willingness of 
patients to participate in a future formal trial of the technology.  
• Understanding how best to implement the technology and 
designing of the contents of the VR intervention. 
• Understanding the effective mechanisms for the analgesic effect of 
VR and explore how this could be tailored to individual patients. 
POPULATION 
Patients attending the Outpatient Hysteroscopy clinics 
ELIGIBILITY 
Patients undergoing Outpatient Hysteroscopy 

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DURATION 
6 months 
 
 
1. 
INTRODUCTION  
 
1.1 
BACKGROUND 
Performing procedures for investigation and treatment of gynaecological conditions 
in the office setting is becoming commonplace. Outpatient gynaecological 
procedures can reduce risks of general anaesthetic, decrease health care costs and 
make the procedure more convenient for the patient and provider. However, 
ensuring adequate pain relief and allaying anxiety during the procedure can prove to 
be challenging. Appropriate patient selection, counselling and adequate pain 
management during the procedure can improve patient experience and reduce the 
number of failed procedures.  
Common office gynaecological procedures include outpatient hysteroscopy, 
colposcopy and large loop excision of transformation zone, manual vacuum 
aspiration for treatment of miscarriages, intrauterine contraceptive device insertion, 
hysteroscopic sterilisation and endometrial biopsy.  
 
Pain in gynaecological procedures can originate from the cervix and uterus. The 
uterine fundus is innervated by sympathetic fibres from T10 to L2, which enter 
through the uterosacral ligaments via the inferior hypogastric plexus, and by nerves 
from the ovarian plexuses at the cornua. Parasympathetic fibres from S2 to S4 travel 
through the broad ligament to enter the cervix at the 3 0 clock and 9 o clock positions 
to provide innervation to the upper vagina, cervix and the lower uterine segment. The 
pudendal nerve (S 2,3, 4) supplies the lower vagina and vulva.  
 
Physical, psychological and social factors influence the intensity of pain experienced. 
Counselling the patients pre procedurally helps to better manage expectations and 
pain. 
 
Outpatient hysteroscopy is usually performed for patients having abnormal uterine 
bleeding and subfertility. Pain levels during this procedure can be influenced by the 

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diameter of the hysteroscope. Mini hysteroscopes with an outer diameter of 3.5 mm 
have been associated with lower pain scores. (Paulo et al., 2015) Additional 
procedures performed (like polypectomy or Coil insertions) could increase the 
duration of the procedure and the pain experienced during the procedure. Pain 
scores in the vaginoscopic approach have been noted to be 3.8 when compared to 
5.3 in the traditional group, which uses a speculum and tenaculum. (Sagiv et al., 
2006)  
Pain in hysteroscopy is significantly related to the presence of cervical synechiae, to 
the duration of the procedure, and to the use of normal saline; conversely, parity 
seems to have a protective role.(Mazzon et al., 2014) 
Previous vaginal deliveries, experience of the operator and quicker operative time 
are known to be associated with successful outcomes of the outpatient procedures. 
However, nulliparity, postmenopausal status, anxiety and anticipated pain and a 
history of dsymenorrhoea are known to be associated with higher perception of pain 
and reduced success rates. (Ireland and Allen, 2016, de Carvalho Schettini et al., 
2007) 
 
The type of pain relief offered can include various levels of sedation, local 
anaesthetic, analgesics and verbal support techniques through distraction by 
conversation, gentle language, music, guided imagery and positive suggestion. A 
Cochrane Review showed no consistent good quality evidence of a significant 
difference in safety or effectiveness between different types of pain relief compared 
with each other or with placebo/ no treatment. (Ahmad et al., 2010) There is no 
consensus on the choice of analgesia for outpatient hysteroscopy and rescue 
analgesia in the form of intracervical blocks is often used. (O'Flynn et al., 2011) 
 
 In the UK, most units offer analgesics either as NSAIDs, acetaminophen or oral 
opiods. NSAIDS such as ibuprofen decrease uterine activity and pain by inhibiting 
cyclooxygenase and thereby reduce circulating prostaglandins. They reduce pain 
levels especially postoperatively. Acetaminophen also inhibits the enzyme 
cyclooxygenase, but its action is in the central nervous system rather in the 
periphery. Hence is inferior to NSAIDS but is offered to women who cannot tolerate 
NSAIDS. Oral opiods act by interacting with endogenous opioid mu receptors. 
(Ireland and Allen, 2016) 

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The only pharmacological method that has demonstrated its effectiveness in 
reducing pain during and 30 minutes after hysteroscopy in several meta-analysis and 
reviews is paracervical block. (del Valle et al., 2016) However, it fails to anaesthetise 
the uterus for intrauterine procedures and a previous Cochrane review was unable to 
confirm this. (Tangsiriwatthana et al., 2009) The administration of the local 
anaesthetic itself may be uncomfortable, have side effects due to toxicity, may 
cancel the beneficial effect of performing a vaginoscopic hysteroscopy and does not 
anaesthetise the uterus. Addition of soda bicarbonate as a buffering agent to the 
local anaesthetic and using dental syringes with a 27-gauge needle has been seen 
to decrease the pain during the injection. Topical local anaesthetics on the cervix in 
the form of gel or sprays have not been shown to be effective.  
 
Women undergoing outpatient hysteroscopy experience significant levels of 
preoperative anxiety which is higher than patients attending the gynaecology clinic 
and comparable to those experienced before major surgery under general 
anaesthesia. (Gambadauro et al., 2015, Gupta et al., 2004) 
Anxiolytics help reduce anxiety, however they do not have a direct analgesic effect. 
Units often employ a trained person to engage with the patient to provide emotional 
support during the procedure.  
 
Distraction Techniques 
Type of distraction techniques range from active distraction techniques to passive 
techniques. Active distraction included interactive toys, virtual reality, guided imagery 
and relaxation and controlled breathing. Passive distraction techniques included 
auditory distraction in the form of music and audio-visual distraction through 
watching television. Intraoperative pain and anxiety rating have been noted to be 
lower by use of simple intraoperative distraction techniques e.g. interacting with 
nurses, watching DVDs or using stress balls. (Hudson et al., 2015) 
 
There has been limited research done on the role of distraction techniques in pain 
management in outpatient gynaecological procedures. Music has been used as a 
complementary method to control anxiety and reduce perception of pain by relaxing 
the patient and causing less discomfort during outpatient hysteroscopy. (Angioli et 

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al., 2014). However, a RCT showed no positive effect of music on patients' level of 
pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and 
colposcopy.(Mak et al., 2017). Watching the procedure on the screen at office 
hysteroscopy has not been shown to reduce pain scores.(Ogden et al., 2009) 
Women with high level of preprocedural state- trait anxiety are more likely to 
perceive higher levels of pain and discomfort during colposcopy. (Baser et al., 2013) 
Simple passive visual distraction during colposcopic examination was associated 
with a reduction in pain scores, however anxiety levels were unchanged. (Carwile et 
al., 2014) A Cochrane review in 2007 concluded that anxiety appears to be reduced 
by playing music during colposcopy.  Although information leaflets did not reduce 
anxiety levels, they did increase knowledge levels and helped with consenting for the 
procedure. (Galaal et al., 2007) 
 
Virtual reality is a relatively new intervention, which has been studied as a non-
pharmacological method for pain relief. (Loreto-Quijada et al., 2013, Loreto-Quijada 
et al., 2014). VR as a form of managing pain has been studied in paediatrics, 
dentistry, burns treatment, treatment of chronic pain. (Hoffman et al., 2000) It has not 
been studied in the management of pain of gynaecological procedures, which are 
increasingly being performed as office procedures.  
It acts as a method of distraction for pain relief by changing the activity of the body’s 
pain modulation system. This multisensory technology gives an immersive and 
engaging experience and serves as a distraction technique. Head tracking systems, 
visually stimulating scenery and audio and tactile feedback enable integration of 
many 
sensory 
experiences. 
Different 
psychological 
factors 
influence 
the 
effectiveness of the analgesic effect of VR. While sense of presence influence the 
effectiveness of VR as a distraction tool, anxiety as well as positive emotions directly 
affects the experience of pain. (Triberti et al., 2014) 
VR distraction has been associated with significant increases in pain threshold and 
pain tolerance and significant decreases in pain intensity, time spent thinking about 
pain, and self-reported anxiety, relative to baseline. Repeated exposure did not 
appear to affect the benefits of VR. (Rutter et al., 2009). Simultaneous exposure to 
VR and supplementary sound increases pain tolerance. (Johnson and Coxon, 2016) 
 

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Pain management in ambulatory procedures should be multimodal and should 
include both pharmacological and non-pharmacological interventions. Giving the 
patient a range of options will increase the number of successful procedures in the 
outpatient setting and improve patient experience.  
 
1.2 
RATIONALE FOR CURRENT STUDY 
 
To study the role of distraction techniques for management of acute pain in 
ambulatory gynaecology procedures and to assess feasibility of using Virtual Reality 
for managing pain. 
 
2.  STUDY OBJECTIVES 
 
Primary objective:  
• Feasibility of using virtual reality as a distraction technique in management of 
acute pain in patients undergoing Outpatient Hysteroscopy.  
 
Secondary objectives:  
• Understanding the acceptability and effectiveness of VR interventions within 
the procedural groups and how these might vary as a function of different 
patient demographics.  
• Understanding the factors that might influence the willingness of patients to 
participate in a future formal trial of the technology.  
• Understanding how best to implement the technology and designing of the 
contents of the VR intervention. 
• Understanding the effective mechanisms for the analgesic effect of VR and 
explore how this could be tailored to individual patients. 
 
3.  STUDY DESIGN 
 
The study is a randomised control trial involving mixed methods of qualitative and 
quantitative analysis. Participants will be recruited for the study at the Gynaecology 
Department at Whipps Cross University Hospital, Barts Health NHS Trust from June 

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2018 to October 2018. The patients will be identified from the gynaecology clinic by 
the clinicians who schedule them for Outpatient Hysteroscopy procedure. The study 
will include 40 patients attending the outpatient hysteroscopy clinic and randomised 
to either a VR intervention group or standard procedure by computer-generated 
randomisation. 
 
They will be given a study information sheet, an invitation to participate with a reply 
slip to indicate whether they would like to participate in the study. Patients will be 
given standard pre procedural information about the procedure as per standard 
practice. Written informed consent will be obtained from participants and the 
interview outputs will be anonymisied.  
 
 All patients will fill in a questionnaire before and after the procedure. Patients who 
have been randomised to the VR arm will have a semi-structured interview regarding 
their experience with VR. 
 
The staff in the clinic will include a clinician performing the procedure and a staff 
nurse supporting the clinic. They will be given a study information sheet regarding 
the study and a written informed consent for a questionnaire will be obtained from 
them if they agree to participate. The clinician performing the procedure will fill in a 
questionnaire per patient regarding the ease of the procedure and perceived pain 
levels of the patient. The Clinician performing the procedure and nursing staff’s 
perception regarding feasibility of using the VR equipment for each patient who had 
the intervention was also assessed through the questionnaire. The staff 
questionnaire responses will be anonymised by assigning a unique staff number for 
each of the staff. The list of the names of the staff and the study number allocated 
will be saved by the PI on a separate file.  
 
Patient follow up will not be routinely arranged for the purpose of the study. Routine 
follow up as per clinical requirements will be arranged as routine for the procedure 
performed.  
 
 
  

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3.1 
STUDY OUTCOME MEASURES 
Efficacy of VR in acute pain management 
Feasibility of VR implementation during office gynaecology procedures 
 
4. 
PARTICIPANT ENTRY  
 
4.1 
PRE-REGISTRATION EVALUATIONS  
Clinical indications for undergoing an office hysteroscopy will be confirmed. 
Staff in the outpatient hysteroscopy clinic. 
 
4.2 
INCLUSION CRITERIA 
Patients: Inclusion criteria will include all women of at least 18 – 70 years of age, 
planned for an office hysteroscopy. 
Staff: Inclusion criteria will include the clinician performing the outpatient 
hysteroscopy and the nurse supporting the clinic. 
 
4.3 
EXCLUSION CRITERIA 
Patients:  
• Hearing impairments and blindness  
• Any known anatomical characteristics that may make performing the office 
procedure more difficult (e.g., cervical conization, Manchester Fothergill). 
• The denial or withdrawal of oral informed consent 
Staff: The denial or withdrawal of informed consent 
 
4.4 
WITHDRAWAL CRITERIA 
Patients and staff can withdraw from the study if they so desire at any time and 
without giving a reason. A decision to withdraw at any time, or a decision not to take 
part, will not affect the standard of care / treatment that they receive.  
 
 
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 will 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, will also be 
considered serious. 
 
5.3 
REPORTING PROCEDURES 
All adverse events will be reported.  Depending on the nature of the event the 
reporting procedures below will be followed.  Any questions concerning adverse 
event reporting will be directed to the Chief Investigator in the first instance.   
 
5.3.1 Non serious AEs 
All such events, whether expected or not, will be recorded.   
 
5.3.2 Serious AEs 
An SAE form should be completed and faxed to the Chief Investigator within 24 
hours.  However, relapse and death due to <condition>, and hospitalisations for 
elective treatment of a pre-existing condition do not need reporting as SAEs. 

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All SAEs should be reported to Newcastle and North Tyneside 1 National 
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 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 
Fax: xxx, attention xxx 
Please send SAE forms to: xxx 
Tel: xxx (Mon to Fri 09.00 – 17.00) 
 
6. 
ASSESSMENT AND FOLLOW-UP  
 
The study will aim to recruit 40 patients and randomise them via computer generated 
random number allocation to either the VR intervention group or those having 
treatment as per routine protocol.   
 
Both groups of patients will fill a pre and post procedural questionnaire. Pain and 
anxiety scores prior to the procedure and after the procedure will be compared 
against a control group of 20 patients for pain management by standard protocol. 
Scores will be measured by a Numeric Rating Scale (NRS) which is a validated 
measure of pain which is easy to use, has high compliance rates and is detects 

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meaningful changes in pain.  The NRS is an 11-point scale consisting of integers 
from 0 through 10; 0 representing ‘‘No pain’’ and 10 representing ‘‘worst imaginable 
pain.’’ Respondents select the single number that best represents their pain 
intensity. Ratings of pre-operative anxiety were measured by an 11-point numeric 
rating scale. (NRS; Kindler et al., 2000): ‘How would you rate any anxiety you may 
currently be feeling’ 0 (no anxiety) and 10 (worst anxiety imaginable).  
The VR intervention will involve watching a standard content of the video on a mobile 
device using a VR headset to distract them during the procedure. The duration of the 
video will be 15 minutes; but the video will only be played for the duration of the 
outpatient hysteroscopy. Patients are allowed to stop viewing the video if they so 
desire and this will be recorded.  
 
 
A semi-structured interview will be conducted with the patients who have received 
the VR intervention, each lasting approximately 20 minutes. The semi structured 
interviews will allow for all participants to be asked similar question within a flexible 
framework.(Dearnley, 2005, Tindall, 2009) The interviews will be conducted within 30 
minutes of the procedure, in a suitable location and will be recorded on a digital 
voice recorder. The questions will be focused on the women’s experiences of the 
procedure, in specific pain perception and questions around the VR intervention as 
well as any other aspect of their hospital care they felt to be relevant. If further 
clarification or exploration of any particular aspect of their care was required, the 
interview will readdress these topics before the end of the interview. Interviews will 
continue until no new information was being obtained, indicating that the theoretical 
saturation point had been reached. (Pope et al., 2000)  
 
Clinician and nursing staff’s perception regarding feasibility of using the VR 
equipment was also assessed through a questionnaire. The clinician questionnaire 
will also assess the ease of the procedure and perceived pain scores for the patient.  
 
Patient follow up will not be routinely arranged for the purpose of the study. Routine 
follow up as per clinical requirements will be arranged as routine for the procedure 
performed.  
 

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The study will end once the proposed numbers of patients have been recruited and 
data analysis completed. Participants will be debriefed after their participation in the 
study and will be directed to suitable support agencies if necessary.  
 
7. 
STATISTICS AND DATA ANALYSIS 
 
The recruitment of women and interviewing proceeded alongside data coding and 
preliminary analysis.  
Interviews will be transcribed verbatim and initially coded by reading and re reading 
the transcript and making notes, drawing on the observations made during the 
interviews and transcription. Transcripts will be coded line-by-line, describing, 
summarising and attending to linguistic elements such as pronoun and metaphor 
use. (Tindall, 2009) The transcripts will be entered into a qualitative software 
package (N6) and a thematic analysis undertaken from the emergent themes 
developed from these codes and cluster with related themes. Initial coding is Initial 
phase will involve open coding. Axial coding and selective coding with use of 
constant comparison will enable a cyclical and iterative process on the principles of 
grounded theory. Analytic frame for the analysis will be linked to the primary and 
secondary aims.  
The statistically analysis with include statistical comparison of pre and post anxiety 
and pain scores as a function of membership of VR or control groups. Analysis of 
covariance (ANCOVA) will be used to determine whether the VR intervention led to a 
significantly difference between baseline and follow up pain and anxiety scores 
between VR and control arm. 
Staff questionnaires will be analysed to correlate pain scores of actual vs. perceived 
and feasibility of carrying out the intervention will be assessed.  
Demographic data would include age, parity, menopausal status and ethnicity. 
Data and all appropriate documentation will be stored for a minimum of 10 years 
after the completion of the study, including the follow-up period.   
 
8. 
REGULATORY ISSUES 
 

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8.1 
ETHICS APPROVAL 
The Chief Investigator has obtained approval from the Newcastle and North Tyneside 1 
National Research Ethics Committee..The study must be submitted for Site Specific 
Assessment (SSA) at each participating NHS Trust.  The Chief Investigator will 
require a copy of the Trust R&D approval letter before accepting participants into the 
study.  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 will 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 will be obtained.  The right of the 
participant to refuse to participate without giving reasons will 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 will 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. 
In the event of the patient and the staff nurse consenting for the study but the 
gynaecologist not consenting for the procedure, the patient will be recruited and 
randomised as per protocol. In the event of the patient and the gynaecologist 
consenting for the study, but the staff nurse not consenting for the procedure, the 
patient will be recruited and randomised as per protocol. In these instances, the staff 
nurse and / or the gynaecologist will not fill the questionnaire and a note will be 
made.  
 
8.3 
CONFIDENTIALITY 
 
Confidentiality 
Information related to participants will be kept confidential and managed in 
accordance with the Data Protection Act, NHS Caldecott Principles, The 

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Research Governance Framework for Health and Social Care, and the 
conditions of Research Ethics Committee Approval. 
 
- Record Retention and Archiving 
When the research trial is complete, the records are kept for a further 10 
years. The approved repository for long-term storage of local records is the 
Trust Modern Records Centre  
 
The Chief Investigator will preserve the confidentiality of participants taking part in 
the study and is registered under the Data Protection Act. 
 
8.4 
INDEMNITY 
Imperial College London holds negligent harm and non-negligent harm insurance 
policies that apply to this study. 
 
8.5 
SPONSOR 
Imperial College London 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 
The study is a part of an MSc thesis and there is no funding this study.  
 
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 Nandita Deo, 
Consultant Obstetrician and Gynaecologist and PI for the study.   
 
10. 
PUBLICATION POLICY 
 

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On completion of the study, the MSc thesis dissertation will be published as per 
Imperial College policy and publication of the findings will be done via peer-reviewed 
journals. 
 
 
10. 
REFERENCES 
 
AHMAD, G., O'FLYNN, H., ATTARBASHI, S., DUFFY, J. M. & WATSON, A. 2010. 
Pain relief for outpatient hysteroscopy. Cochrane Database Syst Rev, 
Cd007710. 
ANGIOLI, R., DE CICCO NARDONE, C., PLOTTI, F., CAFA, E. V., DUGO, N., 
DAMIANI, P., RICCIARDI, R., LINCIANO, F. & TERRANOVA, C. 2014. Use of 
music to reduce anxiety during office hysteroscopy: prospective randomized 
trial. J Minim Invasive Gynecol, 21, 454-9. 
BASER, E., TOGRUL, C., OZGU, E., ESERCAN, A., CAGLAR, M. & GUNGOR, T. 
2013. Effect of pre-procedural state-trait anxiety on pain perception and 
discomfort in women undergoing colposcopy for cervical cytological 
abnormalities. Asian Pac J Cancer Prev, 14, 4053-6. 
CARWILE, J. L., FELDMAN, S. & JOHNSON, N. R. 2014. Use of a simple visual 
distraction to reduce pain and anxiety in patients undergoing colposcopy. J 
Low Genit Tract Dis, 18, 317-21. 
DE CARVALHO SCHETTINI, J. A., RAMOS DE AMORIM, M. M., RIBEIRO COSTA, 
A. A. & ALBUQUERQUE NETO, L. C. 2007. Pain evaluation in outpatients 
undergoing diagnostic anesthesia-free hysteroscopy in a teaching hospital: a 
cohort study. J Minim Invasive Gynecol, 14, 729-35. 
DEARNLEY, C. 2005. A Reflection on the Use of Semi-Structured Interviews, The 
Nurse Researcher. 
DEL VALLE, C., SOLANO, J. A., RODRIGUEZ, A. & ALONSO, M. 2016. Pain 
management in outpatient hysteroscopy. Gynecology and Minimally Invasive 
Therapy, 5, 141-147. 
GALAAL, K. A., DEANE, K., SANGAL, S. & LOPES, A. D. 2007. Interventions for 
reducing anxiety in women undergoing colposcopy. Cochrane Database Syst 
Rev, Cd006013. 

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APPENDICES 
1. Patient Questionnaire 
2. Semi structured interview questions for patients who have had the distraction 
technique (VR) 
3. Staff Questionnaire 
4. Patient information Leaflet 

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5. Staff Information Leaflet 
6. Patient Consent form with reply slip. 
7. Staff Consent form