Virtual Reality in MVA for Miscarriage

Miscarriage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04466956
• Other study ID #: 271029
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2022
• Source: Barts & The London NHS Trust
• Contact: Anna A McDougall, MRCOG
• Phone: 07739846763
• Email: anna.mcdougall[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 31, 2023
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage

Intervention

Device:
• Virtual reality
Virtual reality headset worn with short relaxing video played during MVA procedure

Locations

Country	Name	City	State
United Kingdom	North Middlesex University Hospital	London
United Kingdom	Whipps Cross University Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	North Middlesex University Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety rating	Anxiety score (numerical rating score 0 least-10 worst) and questionnaire	12 months
Primary	Pain rating	Pain score (numerical rating score 0 least-10 worst) and questionnaire	12 months