NCT04466956

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2023

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 25, 2024

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

July 7, 2020

Results QC Date

March 25, 2024

Last Update Submit

November 15, 2024

Conditions

Miscarriage

Keywords

ManagementAnxietyPain

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Virtual reality for reduction of pain and anxiety during MVA

ACTIVE COMPARATOR

25 participants randomised to use VR headset during MVA and complete questionnaire and short interview regarding experience

Device: Virtual reality

Control group- no VR

NO INTERVENTION

25 participants randomised to not use VR headset during MVA and complete questionnaire and short interview regarding experience

Interventions

Virtual realityDEVICE

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

Virtual reality for reduction of pain and anxiety during MVA

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Whipps Cross University Hospital

London, E11 1NR, United Kingdom

Location

North Middlesex University Hospital

London, N18 1QX, United Kingdom

Location

MeSH Terms

Conditions

Abortion, SpontaneousAnxiety DisordersPain

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Anna McDougall
Organization
Barts Health NHS Trust
anna.mcdougall@nhs.net
02078827272

Study Officials

  • Nandita Deo, MRCOG

    Barts & The London NHS Trust

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Intervention 25 and control 25
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 10, 2020

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

January 27, 2023

Last Updated

November 25, 2024

Results First Posted

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Plan to publish results

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
At completion of study anticipated 2022
Access Criteria
Public

Locations

GB(2)