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Virtual Reality and Outpatient Hysteroscopy

NCT03699280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-02-02

Study results available
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Summary

TITLE Virtual Reality (VR) as a Distraction technique for management of acute pain at Outpatient Hysteroscopy DESIGN Randomised Control Trial (RCT) with Mixed methods - Qualitative and quantitative AIMS To study the role of distraction techniques for management of acute pain in Outpatient Hysteroscopy and to assess feasibility of using Virtual Reality for managing pain.

Primary objective:

• Feasibility of using virtual reality as a distraction technique in management of acute pain in patients undergoing Outpatient Hysteroscopy.

Secondary objectives:

* Understanding the acceptability and effectiveness of VR interventions within the procedural groups and how these might vary as a function of different patient demographics.
* 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.
* Understanding the effective mechanisms for the analgesic effect of VR and explore how this could be tailored to individual patients.

POPULATION Patients attending the Outpatient Hysteroscopy clinics ELIGIBILITY Patients undergoing Outpatient Hysteroscopy DURATION 6 months

Conditions

  • Acute Pain
  • Hysteroscopy

Interventions

OTHER

Virtual Reality

Oculus Go VR device

Sponsors & Collaborators

  • Barts & The London NHS Trust

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Nandita Deo, FRCOG · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-08-04
Primary Completion
2018-10-06
Completion
2018-10-06

Countries

  • United Kingdom

Study Locations

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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 NCT03699280 on ClinicalTrials.gov