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Completed

NCT Number: NCT06766162

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

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.

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Key information

Conditions

VR Endoscopic Mucosal Resection Endoscopic Submucosal Dissection Virtual Reality Pain Distraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

king's College Hospitals

London, SE5 9RS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality pain distraction

Other

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.

Standard analgesia and sedation

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. The difference in pain scores between the two groups.

    Time frame: 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.

  3. Patient satisfaction.

    Time frame: 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.

  4. Endoscopist satisfaction.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

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

Acronym: VREMRESD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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