Clinical trial NCT06766162: Virtual Reality to Improve Patient Experience During Endoscopic Mucosal and Submucosal Resection
Official title: Virtual Reality and Endoscopic Mucosal and Submucosal Dissection: a Patient Centred Experience "VREMRESD"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: VR
Virtual Reality Pain Distraction
Endoscopic Submucosal Dissection
Endoscopic Mucosal Resection
Keywords: VRESD
Virtual reality and ESD
VR and endoscopic submucosal dissection
Virtual reeality and endoscopic submucosal dissection
VRWMR
VREMRESD
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To assess the feasibility for integrating VR as a pain mediation during EMR/ESD procedure.
timeFrame: During the EMR/ESD procedure
Secondary outcomes:
measure: The change in analgesia and sedation used while using the VR.
timeFrame: During the EMR/ESD prcoedure
measure: The difference in pain scores between the two groups.
timeFrame: baseline, pre-procedure, immediately after the procedure
measure: Patient satisfaction.
timeFrame: immediately after the procedure
measure: Endoscopist satisfaction.
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: king's College Hospitals
Study officials:
References:
citation: 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.
citation: 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.