NCT06766162

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• VR
• Virtual Reality Pain Distraction
• Endoscopic Submucosal Dissection
• Endoscopic Mucosal Resection

Interventions

Type	Name	Description
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.
OTHER	Standard analgesia and sedation	Standard local protocol for analgesia and sedation, incorporating fentanyl and midazolam.

Timeline

• Start date: 2025-05-10
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2025-01-09
• Last updated: 2026-03-11

Locations

1 site across 1 country: United Kingdom