Virtual Reality in MVA for Miscarriage

Not Applicable

Completed

Conditions: Miscarriage

Interventions: Device: Virtual reality

Registration Number: NCT04466956

Lead Sponsor: Barts & The London NHS Trust

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality for reduction of pain and anxiety during MVA	Virtual reality	25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience

Primary Outcome Measures

Name	Time	Method
Anxiety Rating	12 months	Anxiety score (numerical rating score 0 least-10 worst) and questionnaire
Pain Rating	12 months	Pain score (numerical rating score 0 least-10 worst) and questionnaire

Secondary Outcome Measures