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VRDD in Upper Gastrointestinal Endoscopy

NCT06636292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-07-30

No results posted yet for this study

Summary

The demand for gastrointestinal (GI) endoscopy is rising year by year and improving the patient's experience of having the procedure has become an important aim. A lot of work has been done in recent years on how to improve a patient's experience during GI endoscopy such as improving endoscopy and communication skills. Due to the increasing popularity of Virtual Reality (VR) in the gaming world, VR equipment have been used in children as a safe and effective distraction method during GI endoscopy, removing the need for them to have general anaesthesia for their procedure. This has been thought of as an option for the adult patients which would also save them from requiring sedation for their endoscopy procedure.

This is a pilot feasibility study (small scale preliminary study) carried out at a single hospital site with a dedicated GI endoscopy service. We intend to find out whether the VR headset that is used is tolerated and accepted by adult patients during their endoscopy procedure. This has been shown to be a cheaper option compared to giving sedation drugs or general anaesthesia as well. If adult patients can accept this option, we are hoping to investigate in future larger studies whether they could potentially use this as a distraction method to help improve their experience of undergoing GI endoscopy. Any adult patient who is having an upper GI endoscopy could be potentially eligible. Their endoscopy procedure forms part of their clinical care whereas the research component involves them wearing the VR headset before and/or during their procedure. Their experience of undergoing upper GI endoscopy and wearing the VR headset will be measured using a series of questionnaires.

Conditions

  • Patient Satisfaction
  • Patient Acceptance of Health Care

Interventions

DEVICE

Virtual Reality Distraction and Disassociation (VRDD) Stage 1

Participants wear a VR headset which plays VR content/material pre- endoscopy only.

DEVICE

Virtual Reality Distraction and Disassociation (VRDD) Stage 1&2

Participants wear a VR headset which plays VR content/material pre- endoscopy and during endoscopy.

Sponsors & Collaborators

  • EvoEndo, Inc.

    collaborator UNKNOWN

  • South Tyneside and Sunderland NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Phey Shen Lee · South Tyneside and Sunderland NHS Foundation Trust

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-23
Primary Completion
2024-10-10
Completion
2024-10-10

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 NCT06636292 on ClinicalTrials.gov