Virtual Reality in MVA for Miscarriage

December 2, 2022 updated by: Barts & The London NHS Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Collaborators

North Middlesex University Hospital NHS Trust

Investigators

  • Principal Investigator: Nandita Deo, MRCOG, Barts & The London NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 10, 2020

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 2, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 271029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Plan to publish results

IPD Sharing Time Frame

At completion of study anticipated 2022

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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