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

King's College Hospital NHS Trust

Status: Enrolling

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

Treatments: Other: Standard analgesia and sedation; Other: Virtual reality pain distraction

Study type: Interventional

Funder types: Other

Identifiers

NCT06766162

345381 (Other Identifier)

24/LO/0785

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Virtual reality (VR) Arm

Experimental group

Description:

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.

Treatment:

Other: Virtual reality pain distraction

Standard Arm

Active Comparator group

Description:

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

Treatment:

Other: Standard analgesia and sedation