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

Not Applicable

Recruiting

• Conditions: VR; Virtual Reality Pain Distraction; Endoscopic Submucosal Dissection; Endoscopic Mucosal Resection

• Registration Number: NCT06766162
• Lead Sponsor: King's College Hospital NHS Trust

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.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2025-01-07
• Study First Posted: 2025-01-09
• Study Start: 2025-05-10
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess the feasibility for integrating VR as a pain mediation during EMR/ESD procedure.	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.

Secondary Outcome Measures

Name	Time	Method
The change in analgesia and sedation used while using the VR.	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.
The difference in pain scores between the two groups.	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.
Patient satisfaction.	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.
Endoscopist satisfaction.	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.

Trial Locations

Locations (1)

king's College Hospitals; 🇬🇧 London, United Kingdom