NCT06766162

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

May 10, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 11, 2026

Status Verified

December 1, 2024

Enrollment Period

8 months

First QC Date

December 16, 2024

Last Update Submit

March 10, 2026

Conditions

VRVirtual Reality Pain DistractionEndoscopic Submucosal DissectionEndoscopic Mucosal Resection

Keywords

VRESDVirtual reality and ESDVR and endoscopic submucosal dissectionVirtual reeality and endoscopic submucosal dissectionVRWMRVREMRESD

Outcome Measures

Primary Outcomes (1)

  • To assess the feasibility for integrating VR as a pain mediation during 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 Outcomes (4)

  • The change in analgesia and sedation used while using the VR.

    During the EMR/ESD prcoedure

  • The difference in pain scores between the two groups.

    baseline, pre-procedure, immediately after the procedure

  • Patient satisfaction.

    immediately after the procedure

  • Endoscopist satisfaction.

    immediately after the procedure

Study Arms (2)

Virtual reality (VR) Arm

EXPERIMENTAL

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

Standard Arm

ACTIVE COMPARATOR

The control group will follow the standard local protocol for analgesia and sedation throughout the procedure.

Other: Standard analgesia and sedation

Interventions

Virtual reality pain distractionOTHER

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.

Virtual reality (VR) Arm
Standard analgesia and sedationOTHER

Standard local protocol for analgesia and sedation, incorporating fentanyl and midazolam.

Standard Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

king's College Hospitals

London, London, SE5 9RS, United Kingdom

Location

Related Publications (2)

  • Liu Q, Zang Y, Zang W, Cai W, Li W, Guo Y, Xin C, Tu X. Implementation of virtual reality technology to decrease patients' pain and nervousness during colonoscopies: a prospective randomised controlled single-blinded trial. Clin Med (Lond). 2022 May;22(3):237-240. doi: 10.7861/clinmed.2022-0001. Epub 2022 Apr 20.

    PMID: 35443967BACKGROUND

  • Karaveli Cakir S, Evirgen S. The Effect of Virtual Reality on Pain and Anxiety During Colonoscopy: A Randomized Controlled Trial. Turk J Gastroenterol. 2021 May;32(5):451-457. doi: 10.5152/tjg.2021.191081.

    PMID: 34231475BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2024

First Posted

January 9, 2025

Study Start

May 10, 2025

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

March 11, 2026

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)