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Does Virtual Reality Technology Reduce Pain and Anxiety During Outpatient Hysteroscopy?

NCT05307887 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2024-08-09

Study results available
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Summary

Hysteroscopy is a common procedure where a camera attached to a thin scope is passed into the uterus via the vagina and cervix in order to obtain views of the inside of the uterus. Hysteroscopy is used for the diagnosis and management of a variety of benign and conditions as well as the diagnosis of uterine cancer. It can be performed under general anaesthetic or in an outpatient setting without formal anaesthetic. The latter has several advantages when compared to hysteroscopy with general anaesthesia as it avoids the additional risk of general anaesthesia, has a quicker recovery time, shorter hospital stay and reduced cost. However, women may experience discomfort or pain during an outpatient procedure and pain is one of the most common reasons for failure to complete the procedure.

The most appropriate way to manage pain and anxiety during outpatient hysteroscopy is not yet fully understood and conventional therapy, as recommended by the Royal College of Obstetricians and Gynaecologists, involves the use of simple pain killers taken prior to the procedure and sometimes local anaesthetic during the procedure. In recent years virtual reality software has been developed and used in a variety of different settings to alleviate pain and anxiety during medical procedures.

This study aims to investigate whether the use of virtual reality as an adjunct to conventional pain management can reduce anxiety and pain during outpatient hysteroscopy. The study will take the form of a randomised controlled trial at St Mary's hospital London. A randomly selected group of patients undergoing outpatient hysteroscopy with conventional management plus the addition of virtual reality software will be compared to a control group of patients undergoing the procedure with conventional management only.

Conditions

Interventions

DEVICE

Sync VR Medical PICO G2 4K Virtual Reality Technology

Virtual reality headset and software

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-25
Primary Completion
2022-10-11
Completion
2022-10-11

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05307887 on ClinicalTrials.gov