Virtual Reality in MVA for Miscarriage

Study Overview
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Brief Summary
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We are investigating the use of a virtual reality programme to reduce pain and anxiety experienced during manual vacuum aspiration. Virtual reality (VR) is the computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real way by a person using special electronic equipment. In this study a VR headset is worn by the patient allowing them to experience a relaxing environment whilst the procedure manual vacuum aspiration (MVA) is performed. VR is mostly used in computer gaming but has uses in medical field and has been used in the treatment of long standing pain, treatment of burns, dentistry and treatment of cancer pain. However, its role in the management of pain and anxiety during gynaecological procedures like manual vacuum aspiration has not been researched. This study explores whether it has a place in the treatment of gynaecological pain and reduction of anxiety.

Detailed Description
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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. The rationale for this study is to invetsigate 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 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. 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.

Official Title
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Virtual Reality as a Distraction Technique for the Management of Acute Pain and Anxiety During Manual Vacuum Aspiration for Miscarriage

Conditions
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Miscarriage

Intervention / Treatment
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* Device: Virtual reality


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Hearing impairments and blindness History of epilepsy or any previous seizures 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention 25 and control 25
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Virtual reality for reduction of pain and anxiety during MVA<br>25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience | Device: Virtual reality<br>* Virtual reality headset worn with short relaxing video played during MVA procedure<br>|
| No Intervention: Control group- no VR<br>25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety rating | Anxiety score (numerical rating score 0 least-10 worst) and questionnaire | 12 months | 
| Pain rating | Pain score (numerical rating score 0 least-10 worst) and questionnaire | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Management, Anxiety, Pain