Virtual Reality as a Distraction Technique for the Management of Acute Pain and Anxiety During Manual Vacuum Aspiration for Miscarriage
Phase: NA
Conditions: Miscarriage
Sponsor: Barts & The London NHS Trust

 
 
 
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JRMO Research Protocol for  
Interventional Studies  
 
 
Full Title  
Virtual reality as a distraction technique for 
the management of acute pain and anxiety 
during manual vacuum aspiration for 
miscarriage 
 
Short Title 
Virtual Reality in Manual Vacuum Aspiration 
 
Sponsor 
Barts Health NHS Trust 
Contact person: 
 
Dr Mays Jawad 
Research & Development Governance 
Operations Manager 
Joint Research Management Office 
 
5 Walden Street 
 
London 
 
E1 2EF 
 
Phone: 020 7882 7275/6574 
 
Email: research.governance@qmul.ac.uk  
 
 
IRAS Number 
271029 
REC Reference 
 
 
20/LO/0069 
Chief Investigator 
Miss Nandita Deo  
Consultant Obstetrician and Gynaecologist 
Whipps Cross Hospital, Leytonstone, London 
E11 1NR 
07939 360357 
nandita.deo@nhs.net 
 
List of sites 
1. Whipps Cross Hospital, Leytonstone, London 
E11 1NR 
 
2. North Middlesex University Hospitals NHS 
Trust, Sterling Way, London N18 1QX 
 
Study Manager 
 
 
Dr Anna McDougall 
Specialist Registrar Obstetrics and 
Gynaecology 
North Middlesex University Hospitals NHS 
Trust, Sterling Way, London N18 1QX 
07739 846763 
anna.mcdougall@nhs.net 
 
Principal Investigator NMUH 
Miss Schahrazed Rouabhi 
Consultant Obstetrician and Gynaecologist 
North Middlesex University Hospitals NHS 
Trust, Sterling Way, London N18 1QX 

 
 
 
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07763 246979 
Schahrazed.rouabhi@nhs.net 
 
 

 
 
 
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1. Contents 
 
1. 
Contents 
32. 
Glossary 
43. 
Signature page 
54.
 
Summary and synopsis 
65. 
Introduction 
75.1 
Background
 
85.2 
Preclinical data 
85.3 
Clinical data 
95.4 
Rationale
 
105.5 Risks / benefits 
106. 
Study objectives 
106.1 Primary 
objective 
106.2 Secondary objectives 106.3 Primary endpoint 
106.4
 
Secondary endpoint 107. 
Study population 
117.1 Inclusion criteria
 
117.2 Exclusion criteria 
118. 
Study design 119. 
Study procedures
 
1210. Assessment and management of risk 
1311. Statistical 
considerations 1311.1 Sample size 
1311.2 Method of analysis 
1312. Ethics
 
1413. Public Involvement 
1414. Data handling and record keeping
 
1514.1 Data management 
1514.2 Source data 
1514.3 Confidentiality
 
1514.4 Record Retention and Archiving 
1515. Interventions and tools
 
1515.1 Devices 
1515.2 Tools 1616. Safety reporting 
1616.1
 
Adverse Events (AEs) 1616.2 Adverse Reaction (ARs) 
1616.3 Notification 
and reporting of Adverse Events and Reactions 
1616.4 Serious Adverse Events 
(SAEs) or reactions 
1616.5 Notification and reporting of Serious Adverse Events
 
1716.6 Urgent Safety Measures 
1716.7 Annual Safety Reporting
 
1716.8 Overview of the Safety Reporting responsibilities 
1717. Monitoring 
and auditing 
1718. Trial committees 
1819. Finance and funding 1820.
 
Indemnity 
1821. Dissemination of research findings 1822.
 
References 
18 
 

 
 
 
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2. Glossary 
 
MVA 
Manual vacuum aspiration 
SMM 
Surgical management of miscarriage 
VR 
Virtual Reality 
 
KEYWORDS 
Distraction techniques 
Acute pain 
Anxiety 
Manual vacuum aspiration 
Virtual reality 
 
 

 
 
 
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3. Signature page 
 
 
 
Chief Investigator Agreement 
 
The study as detailed within this research protocol will be conducted in accordance 
with the principles of Good Clinical Practice, the UK Policy Framework for Health and 
Social Care Research, and the Declaration of Helsinki and any other applicable 
regulations. I agree to take responsibility for the statistical analysis and oversight of 
this study. 
 
 
Chief Investigator Name: 
_________________ 
 
Signature: 
_________________ 
 
Date: 
_________________ 
 
 
 
 

 
 
 
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4. Summary and synopsis 
 
Short title 
Virtual Reality in Manual Vacuum Aspiration 
Methodology 
Prospective feasibility study 
Research sites 
Whipps Cross Hospital, Barts Health NHS Trust 
North Middlesex University Hospital NHS Trust 
Objectives / aims 
To study the feasibility of using virtual reality as a 
distraction technique for the management of acute pain 
and anxiety during manual vacuum aspiration for 
miscarriage 
Number of 
participants 
30 
Inclusion and 
exclusion criteria 
Women aged 18-50 undergoing manual vacuum 
aspiration 
Statistical 
methodology and 
analysis (if 
applicable) 
Qualitative and quantitative data analysis 
● Patient questionnaire 
● Staff questionnaire 
● Semi-structured patient interview. 
Study duration 
6 months 
 

 
 
 
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5. Introduction 
 
5.1 Background  
 
Many simple gynaecological procedures can be performed in an outpatient 
setting without the need for general anaesthesia. Such office-based 
procedures include outpatient hysteroscopy, endometrial biopsy, large-loop-
excision of the transformation zone and manual vacuum aspiration for the 
management of miscarriage. Advantages experienced by patients include 
reduced anaesthetic risk, enhanced recovery time and flexibility of timings. For 
the healthcare provider there are significant cost benefits on the basis of 
reduced theatre time, staff and equipment. Patient satisfaction is generally high 
but influenced by their experience of pain and feelings of anxiety before, during 
and after the procedure. 
 
 
 
5.2 Preclinical data  
 
Approximately one in four pregnancies end in miscarriage with early pregnancy 
loss accounting for 50,000 hospital admissions a year 1. Treatment options 
include expectant, medical and surgical management with patient preference 
and clinical suitability the key determinants. The standard option for surgical 
management of miscarriage (SMM) involves suction curettage under general 
anaesthesia. In keeping with guidance from the National Institute of Health and 
Care Excellence (NICE) many hospitals now also offer manual vacuum 
aspiration (MVA) using a handheld syringe under local anaesthesia as a safe 
and efficacious alternative 1. Although there are no national guidelines as to 
those patients suitable for MVA the widely accepted consensus excludes 
women who are haemodynamically unstable, those with bleeding disorders 
and uterine malformations and those with retained products of conception 
greater than 5cm or signs of infection 2. As with SMM, risks include uterine and 
cervical injury, pelvic infection, incomplete evacuation and uterine perforation. 
However, as most practitioners carry out the procedure under ultrasound 
guidance, the safety profile with regards to perforation and need for repeat 
procedure are favourable 2.  
 
Like many office gynaecology procedures, MVA involves the insertion of a 
speculum, a degree of cervical dilatation and subsequent uterine intervention 
and therefore has the potential to act as a noxious stimulus at the levels of the 
vulva, vagina, cervix and uterus. Innervation of the uterine body is by 
sympathetic fibres arising from T10-L1 spinal segments, which course through 
the uterosacral ligaments via the inferior hypogastric nerve and ovarian plexus. 
The lower uterine segment, cervix and upper vagina are innervated by 
parasympathetic fibres arising from S2-4 whilst the pudendal nerve arising from 
S2-4 innervates the lower vagina and vulva. 
 
One of the biggest challenges to patient acceptability of MVA is adequate pain 
relief during and after the procedure. The degree of pain experienced varies 
considerably from no pain to significant pain 2. A woman’s anxiety level strongly 
influences her perception of pain and at the time of miscarriage most women 
will experience a period of intense emotional distress. Comfort can be improved 
by the use of a suitable procedure room; kind, empathetic staff and clear 

 
 
 
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counselling with regards to what to expect during and post procedure. 
However, there is a paucity of data on interventions to reduce anxiety during 
MVA. 
 
In the absence of general anaesthesia, pain management options include 
sedation, oral analgesics and paracervical block with local anaesthetic. 
Intravenous sedation is not a practical method for office gynaecology 
procedures, as it requires the presence of an anaesthetist for its administration 
and subsequent airway support. Non-steroidal-anti-inflammatory medications 
are effective in reduction of uterine contraction by the inhibition of cycloxeganse 
and reduction in circulating prostaglandins and patients undergoing MVA are 
recommended to take 400mg Ibuprofen 30-60 minutes prior to procedure 
2.Whilst many outpatient gynaecology procedures are performed following 
administration of a paracervical block, the infiltration will not reach the level of 
the uterine fundus supplied by spinal nerves T10-L1. Furthermore, a Cochrane 
review by Tangsirwatthana et al 2013 concluded that there was a lack of 
evidence to support the use of paracervical block for cervical dilatation and 
uterine intervention 3. 
 
 
5.3 Clinical data  
 
Non-pharmacological methods of pain relief include distraction techniques. 
These may be passive; ie, listening to music, watching television or active; i.e. 
interactive toys, guided relaxation and controlled breathing. Intraoperative pain 
and anxiety ratings have been noted to be lower by use of simple intraoperative 
distraction techniques e.g. interacting with nurses, watching DVDs or using 
stress balls 4. There is however, limited and conflicting evidence for the use of 
distraction techniques in office gynaecology.  
 
A study by Angioli et al 2014, showed a significant reduction in pain and anxiety 
in outpatient hysteroscopy with the use of music however, a subsequent 
randomised controlled trial by Mak et al, 2017 showed no positive effect of 
music on patient’s level of pain, anxiety or satisfaction at outpatient 
hysteroscopy or colposcopy 5,6. Baser et al 2013, demonstrated women with 
high level pre-procedural anxiety to be more likely to perceive higher levels of 
pain and discomfort during colposcopy 7. Simple visual distraction during 
colposcopy has been associated with a reduction in pain score but no change 
in anxiety levels 8.  
 
Virtual reality is a relatively new intervention, which has been utilised as a non-
pharmacological method for pain relief in paediatrics, dentistry, the 
management of chronic pain and the treatment of burns victims 9. It acts as a 
distraction technique by giving an immersive and engaging experience, which 
changes the activity of the body’s pain modulation system. 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 10.  A recent meta-analysis by Mallari 
et al, 2019, supported VR as an effective treatment for reducing acute pain 10. 
A pilot study by Deo et al, 2019, showed promising results for the feasibility of 
immersive VR in outpatient hysteroscopy in reduction of pain and anxiety 
scores 11.  
 

 
 
 
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Pain management in ambulatory procedures should be multimodal and include 
both pharmacological and non-pharmacological interventions. Giving patients 
a range of options will increase the number of successful procedures and 
improve patient experience. 
 
 
5.4 Rationale 
 
To study the role of distraction techniques and the feasibility of using virtual 
reality for the management of acute pain and anxiety experienced by patients 
undergoing manual vacuum aspiration.  
 
 
5.5 Risks / benefits  
 
Potential benefits to participants in the study include reduction in perceived 
pain, reduction in anxiety and increased tolerability of procedure. Potential risks 
to participants include disorientation, nausea and a sensation of motion 
sickness. In those with a history of epilepsy it may induce seizures 12.   
 
6. Study objectives 
 
 
6.1 Primary objective 
 
● Feasibility of using virtual reality as a distraction technique in management 
of acute pain and anxiety in patients undergoing manual vacuum aspiration 
for miscarriage. 
 
 
6.2 Secondary objectives 
 
● Understanding the acceptability and effectiveness of VR interventions in office 
gynaecology procedures 
● 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. 
 
 
6.3 Primary endpoint 
 
● Feasibility of using virtual reality as a distraction technique in management 
of acute pain and anxiety in patients undergoing manual vacuum aspiration 
for miscarriage. 
● Recruitment and data analysis of 30 patients 
 
 
6.4 Secondary endpoint 
 
Qualitative and quantitative data from 30 patients in the form of 

 
 
 
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i. 
Patient questionnaire 
ii. Staff questionnaire 
iii. Semi-structured patient interview (from VR group only) 
 
7. Study population 
 
Participants will be recruited for the study at the Gynaecology Departments at Whipps 
Cross University Hospital, Barts Health NHS Trust and North Middlesex University 
Hospital NHS Trust over a 6 month period. The patients will be identified from the early 
pregnancy unit by the clinicians who schedule them for MVA procedure. All patients 
undergoing MVA that fit the eligibility criteria will be invited to participate at the time of 
booking the procedure. The study will recruit 30 patients. 
 
7.1 Inclusion criteria 
 
Patients: Clinical indications for undergoing an MVA will be confirmed. 
Inclusion criteria will include all women of 18 – 50 years of age, planned for a MVA 
who are able and willing to give informed consent.  
 
Staff: Inclusion criteria will include the clinician performing the MVA and the nurse 
supporting the clinic. 
 
 
7.2 Exclusion criteria 
 
Patients:  
● Hearing impairments and blindness  
● History of epilepsy or any previous seizures 
● History of claustrophobia 
● Any known anatomical characteristics that may make performing the office 
procedure more difficult (e.g., cervical conisation) 
● Any known characteristics that make the patient unsuitable for undergoing 
MVA (e.g. known bleeding disorder, gestation >12 weeks) 
● The denial or withdrawal of informed consent 
 
Staff: The denial or withdrawal of informed consent 
 
 
8. Study design 
 
The study is a prospective trial involving mixed methods of qualitative and quantitative 
analysis. The study will include 30 patients attending for MVA who will be offered 
inclusion in the study at the time of booking the procedure.  
 
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 anonymised.  

 
 
 
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All patients will fill in a questionnaire before and after the procedure and the 15 patients 
who use the virtual reality headset will have a semi-structured interview regarding their 
experience. This will be audio recorded. The interview will last approximately 10 
minutes. 
 
The staff in the clinic will include a clinician performing the procedure and a staff nurse 
supporting the clinic to whom both 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 will also be assessed through the questionnaire.  
 
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.  
 
 
9. Study procedures 
 
The study will recruit 30 patients to use VR during MVA. On confirmation of consent 
the patients will be allocated to VR intervention group or no intervention standard care 
for MVA control group. 15 patients will be recruited to each group across both sites. 
Allocation to control or intervention will be performed by computer-generated 
randomisation. All patients will receive the same analgesia as per standard MVA 
protocol using para-cervical block. 
 
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 MVA. 
Patients are allowed to stop viewing the video if they so desire and this will be recorded. 
If the MVA lasts longer than the VR experience the programme can be restarted and 
watched again. 
 
Patients in both groups will fill pre and post procedural questionnaires. Pain and 
anxiety scores prior to and after the procedure will be evaluated. 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 detects meaningful changes in 
pain 13.  
 
A semi-structured interview will be conducted with the VR intervention group patients 
each lasting approximately 10 minutes. The semi-structured interviews will allow for 
participants to be asked similar questions within a flexible framework 14,15.  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, their pain perception, anxiety levels 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 is obtained, indicating that 

 
 
 
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the theoretical saturation point has been reached 16.  
 
Clinician and nursing staff’s perception regarding feasibility of using the VR equipment 
will also be 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.  
 
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 or treatment that they receive.  
 
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.  
 
10. Assessment and 
management of risk 
 
Possible risks of participation in the study include the potential to experience the side 
effects of nausea, headaches and motion sickness during the use of VR programme. 
Approximately 25-40% of users of VR experience these symptoms. The risks are 
greater with prolonged use of more than 30 minutes 12. VR is a known trigger for 
seizures in those with a history of epilepsy, for this reason women with any history of 
seizures or epilepsy will be excluded from the study. 
 
Participants will be informed of these risks at the time of invitation to the study and 
details will be included in the patient information leaflet. Any participant wishing to end 
the VR programme may do so at anytime and this will be recorded.  
 
11. Statistical considerations 
 
11.1 
Sample size 
 
The study will include 30 patients with 15 patients in the VR intervention group and 
15 patients in the MVA standard care control group. 
 
o        11.2     Method of analysis  
 
The recruitment of women and interviewing will proceed alongside data coding and 
preliminary analysis.  
 
The statistical analysis will include statistical comparison of pre and post anxiety and 
pain scores. Interview analysis will be performed by the chief investigator and/or study 
manager. 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, 

 
 
 
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summarising and attending to linguistic elements such as pronoun and metaphor use. 
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, which involves 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.  
 
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 and ethnicity. 
 
Data and all appropriate documentation will be stored for a minimum of 20 years after 
the completion of the study, including the follow-up period.   
 
12. Ethics 
 
The Chief Investigator will obtain approval from an NHS ethics committee. 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. 
 
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. 
 
Confidentiality 
Information related to participants will be kept confidential and managed in accordance 
with the Data Protection Act, NHS Caldecott Principles, The Research Governance 
Framework for Health and Social Care, and the conditions of Research Ethics 
Committee Approval. 
 
Conflicts of interest 
The CI and PI have no conflicts of interest. 
 
 
13. Public Involvement 
 

 
 
 
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The inspiration for this study was a patient’s inquiry about using her own VR headset 
during MVA. They subsequently aided in the study design, choosing of video content 
and the VR device. Informal feedback from patients offered the VR device during MVA 
procedure include “good distraction”; “visual nature goggles helped so I didn’t watch 
or listen” and “wouldn’t want to see the procedure”.  
  
14. Data handling and record 
keeping 
 
14.1 
Data management 
 
The Chief Investigator will preserve the confidentiality of participants taking part in the 
study and is registered under the Data Protection Act. 
 
 
14.2 
Source data 
 
Source data will be in the form of patient demographic data, questionnaire and 
interview responses. This information will be managed in accordance with the Data 
Protection Act, the General Data Protection Regulation (GDPR), NHS Caldecott 
Principles, the UK Policy Framework for Health and Social Care Research, and the 
conditions of Research Ethics Committee favourable opinion. 
 
14.3 
Confidentiality 
 
The Chief Investigator will preserve the confidentiality of participants taking part in the 
study and is registered under the Data Protection Act. 
 
Information related to participants will be kept confidential and managed in 
accordance with the Data Protection Act, the General Data Protection Regulation 
(GDPR), NHS Caldecott Principles, the UK Policy Framework for Health and Social 
Care Research, and the conditions of Research Ethics Committee favourable 
opinion.  
 
14.4 
Record Retention and Archiving 
 
When the research trial is complete, the records are kept for a further 20 years. The 
approved repository for long-term storage of local records is the Trust Corporate 
Records Centre  
 
 
15.  Interventions and tools  
 
 
15.1 
Devices 
 
 Oculus Go virtual reality headset which will display a 15 minute VR video.  

 
 
 
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15.2 
Tools 
 
● Numeric Rating Scale (NRS) is a validated measure of pain, which is easy to 
use, has high compliance rates and detects 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 are measured by an 11-point numeric rating 
scale.  ‘How would you rate any anxiety you may currently be feeling’ 0 (no 
anxiety) and 10 (worst anxiety imaginable) 13.  
● Semi structured interviews will allow for all participants to be asked similar 
question within a flexible framework 14,15.  
 
16. Safety reporting  
 
16.1 
Adverse Events (AEs) 
 
An AE is any untoward medical occurrence in a participant to whom an intervention 
has been administered, including occurrences, which are not necessarily caused by 
or related to that intervention. An AE can therefore be any unfavourable or 
unintended sign (including an abnormal laboratory finding), symptom or disease 
temporally associated with study activities. 
 
 
16.2 
Adverse Reaction (ARs)  
 
An AR is any untoward and unintended response in a participant to an intervention.  
All adverse events judged by either the reporting investigator or the sponsor as 
having a reasonable causal relationship to the intervention qualify as adverse 
reactions. The expression ‘reasonable causal relationship’ means in general that 
there is evidence or an argument to suggest a causal relationship. 
 
 
16.3 
Notification and reporting of Adverse Events and Reactions 
 
If the AE is not defined as serious, the AE will be recorded in the study documents 
and the participant followed up by the research team. The AE will be documented in 
the participants’ source documents, the Case Report Form (CRF), and, where 
appropriate, medical records. 
 
 
16.4 
Serious Adverse Events (SAEs) or reactions 
 
A serious adverse event (SAE) is defined as an untoward occurrence that: 
● Results in death, 

 
 
 
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● Is life-threatening, 
● Requires hospitalisation or prolongation of existing hospitalisation, 
● Results in persistent or significant disability or incapacity, 
● Consists of a congenital anomaly or birth defect, or 
● Is otherwise considered medically significant by the investigator. 
 
SARs will be reported to the REC where in the opinion of the Chief Investigator the 
event was serious and: 
● Related (it may have resulted from administration of any of the research 
interventions), and 
● Unexpected (the type of event is not listed in the protocol or other Reference 
Safety Information as an expected occurrence). 
 
 
16.5 
Notification and reporting of Serious Adverse Events  
 
Serious Adverse Events (SAEs) that are considered to be ‘related’ and ‘unexpected’ 
will be reported to the sponsor within 24 hours of learning of the event, and to the 
REC within 15 days in line with the required timeframe.  
 
 
16.6 
Urgent Safety Measures 
 
The CI will take urgent safety measures if necessary to ensure the safety and 
protection of the clinical study participant from immediate hazards to their health and 
safety. The measures will be taken immediately. The approval of the REC prior to 
implementing urgent safety measures is not required. However the CI will inform the 
sponsor and Research Ethics Committee (via telephone) of this event immediately.  
 
The CI will inform the REC in writing within 3 days, in the form of a substantial 
amendment. The sponsor (Joint Research Management Office (JRMO)) will be sent 
a copy of the correspondence with regards to this matter.  
 
 
16.7 
Annual Safety Reporting 
 
The CI will send the Annual Progress Report to the REC using the HRA template (the 
anniversary date is the date on the REC “favourable opinion” letter) and to the 
sponsor.  
 
 
16.8 
Overview of the Safety Reporting responsibilities 
 
The CI is the medical assessor on behalf on the sponsor and will review all events 
reported. The CI will ensure that safety monitoring and reporting is conducted in 
accordance with the sponsor’s requirements.  
 
 
17. Monitoring and auditing 
 

 
 
 
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The sponsor or delegate retains the right to audit any study, study site, or central 
facility. Any part of the study may be audited by the funders, where applicable. 
  
On site monitoring will be performed as per the study monitoring plan. Monitoring will 
include source data verification. 
 
 
18. Trial committees 
 
The study management group will consist of the Chief Investigator and Principal 
Investigator.  
 
The study may be subject to inspection and audit by Barts Health NHS Trust 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).  
 
The day-to-day management of the study will be co-ordinated through Dr Anna 
McDougall, Specialist Registrar in Obstetrics and Gynaecology and PI for the study.   
 
 
19. Finance and funding 
 
Barts Health 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.   
 
There is no funding for this study.  
 
 
20. Indemnity 
 
NHS indemnity scheme will apply. It provides cover for the design, management, and 
conduct of the study. 
 
 
21. Dissemination of research 
findings 
 
On completion of the study, the findings will be published as per Barts Health NHS 
Trust policy and publication of the findings will be done via peer-reviewed journals. 
 
 
 
 
22. References 
 
1. National Institute for Health and Care Excellence. 2019. Ectopic pregnancy and 
miscarriage: diagnosis and initial management. Available at: 
nice.org.uk/guidance/ng126 
 
2. Sharma, M. 2015. Manual vacuum aspiration: an outpatient alternative for surgical 
management of miscarriage. The Obstetrician & Gynaecologist. 17: 157-161 

 
 
 
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3. Tangsirwatthana, T. et al. 2013. Paracervical local anaesthesia for cervical dilatation 
and uterine intervention. Cochrane Database of Systematic Reviews.  
 
4. Hudson, B.F. et al. 2015. Randomised controlled trial to compare the effect of simple 
distraction interventions on pain and anxiety experienced during conscious surgery. 
European Journal of Pain. 19 (10): 1447-1445. 
 
5. Angioli, R. et al. 2014. Use of music to reduce anxiety during office hysteroscopy: 
prospective randomised trial. Journal of Minimally Invasive Gynaecology. 21 (3): 454-
459. 
 
6. Mak, N. et al, 2017. The effect of music in gynaecological office procedures on pain, 
anxiety and satisfaction: a randomised control trial. Gynecological Surgery. 14 (1): 14  
 
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