Virtual Reality to Improve Patient Experience During Endoscopic Mucosal and Submucosal Resection (VREMRESD)

March 10, 2026 updated by: King's College Hospital NHS Trust

Virtual Reality and Endoscopic Mucosal and Submucosal Dissection: a Patient Centred Experience "VREMRESD"

This study explores the feasibility of using Virtual Reality (VR) to manage pain and anxiety during Endoscopic Mucosal (EMR) and Submucosal Dissection (ESD). EMR and ESD often requires sedation or analgesia, which can cause side effects like respiratory or cardiac suppression. VR, by immersing patients in a calming virtual environment, has shown potential in reducing pain and anxiety in medical settings. This study aims to evaluate its application in improving pain management and reducing sedation use during EMR and ESD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study utilizes a prospective randomized controlled trial (RCT) design to evaluate the feasibility of incorporating Virtual Reality (VR) as a method for pain management during Endoscopic mucosal and (EMR) Submucosal Dissection (ESD). Participants will be randomized into two groups: one receiving VR sedation with on-demand analgesia and sedation, and the other following standard sedation protocols. The primary endpoint is to assess the feasibility of integrating VR for pain management during EMR or ESD procedures.

Eligibility criteria ensure that participants are suitable for the study. Patients must be 18 years or older, scheduled for EMR ESD, able to provide informed consent, and proficient in English. Those with contraindications for EMR, ESD, severe impairments affecting VR use, or conditions contraindicating VR are excluded. Endoscopists must be experienced in EMR and ESD, willing to participate, and fluent in English, with non-ESD practitioners or those unwilling to participate excluded.

The study aims to enroll 40 patients (20 per group) and involve five experienced endoscopists from the unit, all of whom will be consented. Secondary endpoints include the proportion of EMR and ESD procedures completed using VR, reductions in sedation and analgesia usage, differences in pain scores between the two groups, and satisfaction levels of both patients and endoscopists.

Follow-up will consist of immediate post-procedure feedback and questionnaires to gather insights on VR's impact. This trial will provide critical data on the potential for VR to enhance patient experience, optimize sedation use, and improve procedural outcomes during EMR and ESD, informing future research and clinical applications.

Study Type

Interventional

Enrollment (Actual)

40

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 Locations

  • United Kingdom
    • London
      • London, London, United Kingdom, SE5 9RS
        • king's College Hospitals

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Able to consent.
  • Fit to use virtual reality.
  • Patients allocated to appropriate EMR/ ESD lists.

Exclusion Criteria:

  • Patients who are unable to consent.
  • Contraindication to use VR including, epilepsy and photosensitivity.
  • Planned other interventional colonoscopy (Polypectomy, Stenting).
  • Visually impaired.
  • Pregnancy.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality (VR) Arm
The VR arm will have a trial run with the VR headset in the endoscopy admission unit. The VR will then be applied at the start of the procedure. If, during the procedure, the patient requests sedation or pain medication, it will be provided. If the patient wishes to remove the VR headset, they may do so at any time.
Other: Virtual reality pain distraction
The intervention group in this study will undergo their EMR and ESD procedure with the addition of virtual reality (VR) as a supportive tool. Participants in this group will use a VR headset during the procedure, designed to provide an immersive experience that may help manage pain and anxiety. The use of VR will be integrated alongside the standard care protocol, including routine sedation and pain management practices VR headset is from DRVR, Rescope innovation which is registered as medical device in the UK.
Active Comparator: Standard Arm
The control group will follow the standard local protocol for analgesia and sedation throughout the procedure.
Other: Standard analgesia and sedation
Standard local protocol for analgesia and sedation, incorporating fentanyl and midazolam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the feasibility for integrating VR as a pain mediation during EMR/ESD procedure.
Time Frame: During the EMR/ESD procedure

This will evaluteed by:

The completed numbers of ESD procedure with the use of the VR as an additive measure to recduce the need for analgesia and sedation.
During the EMR/ESD procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference in pain scores between the two groups.
Time Frame: baseline, pre-procedure, immediately after the procedure
Pain scores will be evaluated by collecting pain scores on a Likert scale from 0 to 10, where 0 means no pain and 10 indicates maximum pain. The mean values will be compared between the two groups.
baseline, pre-procedure, immediately after the procedure
Patient satisfaction.
Time Frame: immediately after the procedure
Patient satisfaction will be evaluated by collecting satisfaction scores on a Likert scale from 0 to 10, where 0 means completely dissatisfied and 10 indicates completely satisfied. The mean values will be compared between the two groups.
immediately after the procedure
The change in analgesia and sedation used while using the VR.
Time Frame: During the EMR/ESD prcoedure
This will be evaluated by calculating the mean amount of diazepam and fentanyl used in both groups to compare the standard pathway for analgesia and sedation with the VR intervention.
During the EMR/ESD prcoedure
Endoscopist satisfaction.
Time Frame: immediately after the procedure
Endoscopist satisfaction with performing EMR/ESD using VR or standard intervention groups will be evaluated by collecting satisfaction scores on a Likert scale from 0 to 10, where 0 means completely dissatisfied and 10 indicates completely satisfied. The mean values will be compared between the two groups.
immediately after the procedure

Collaborators and Investigators

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

Sponsor

King's College Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 10, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24/LO/0785
  • 345381 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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