VRDD in Upper Gastrointestinal Endoscopy

NCT06636292 | Completed

• 1 other identifier: 323884
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The demand for gastrointestinal (GI) endoscopy is rising year by year and improving the patient's experience of having the procedure has become an important aim. A lot of work has been done in recent years on how to improve a patient's experience during GI endoscopy such as improving endoscopy and communication skills. Due to the increasing popularity of Virtual Reality (VR) in the gaming world, VR equipment have been used in children as a safe and effective distraction method during GI endoscopy, removing the need for them to have general anaesthesia for their procedure. This has been thought of as an option for the adult patients which would also save them from requiring sedation for their endoscopy procedure. This is a pilot feasibility study (small scale preliminary study) carried out at a single hospital site with a dedicated GI endoscopy service. We intend to find out whether the VR headset that is used is tolerated and accepted by adult patients during their endoscopy procedure. This has been shown to be a cheaper option compared to giving sedation drugs or general anaesthesia as well. If adult patients can accept this option, we are hoping to investigate in future larger studies whether they could potentially use this as a distraction method to help improve their experience of undergoing GI endoscopy. Any adult patient who is having an upper GI endoscopy could be potentially eligible. Their endoscopy procedure forms part of their clinical care whereas the research component involves them wearing the VR headset before and/or during their procedure. Their experience of undergoing upper GI endoscopy and wearing the VR headset will be measured using a series of questionnaires.

Conditions

Patient Satisfaction; Patient Acceptance of Health Care

Keywords

virtual reality; upper gastrointestinal endoscopy; transnasal endoscopy

Outcome Measures

Primary Outcomes (1)

• Acceptability and tolerability of VRDD in adult patients using VRDD questionnaire

  The acceptability and tolerability of using VRDD in all adult patients referred for upper GI endoscopy, measured on Likert scale via VRDD questionnaire

  2-3 months

Secondary Outcomes (2)

• Acceptability of VRDD in unsedated TNE using VRDD questionnaire

  2-3 months

• Patient experience of using VRDD while having unsedated TNE using Newcastle ENDOPREM™ and mGHAA-9 questionnaires

  2-3 months

Study Arms (2)

Patients having sedated TNE or any oesophagogastroduodenoscopy (OGD)

ACTIVE COMPARATOR

Patients who are only recruited to Stage 1 of study to experience VRDD pre-endoscopy.

Device: Virtual Reality Distraction and Disassociation (VRDD) Stage 1

Patients having unsedated TNE

ACTIVE COMPARATOR

Patients who are recruited to both Stages 1 and 2 of study to experience VRDD pre-endoscopy and during endoscopy.

Device: Virtual Reality Distraction and Disassociation (VRDD) Stage 1&2

Interventions

Virtual Reality Distraction and Disassociation (VRDD) Stage 1 DEVICE

Participants wear a VR headset which plays VR content/material pre- endoscopy only.

Patients having sedated TNE or any oesophagogastroduodenoscopy (OGD)

Virtual Reality Distraction and Disassociation (VRDD) Stage 1&2 DEVICE

Participants wear a VR headset which plays VR content/material pre- endoscopy and during endoscopy.

Patients having unsedated TNE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred with a clinical need for upper GI endoscopy (either transnasal or per oral route) on an elective basis.

You may not qualify if:

• Planned therapeutic procedures (including but not limited to polypectomy, balloon dilatation, stenting).
• Uncorrected visual or auditory impairments or adaptions (e.g. spectacles) that make wearing the VR equipment difficult.
• Cognitive impairment or learning disabilities.
• Epilepsy.
• Balance disorders.
• Referred for urgent or emergency GI endoscopy.
• Withdrawal criteria:
• Patients who withdraw consent from study participation.
• Patients who withdraw consent for having the endoscopy procedure.
• Patients who request to remove the VRDD equipment during Stages 1 or 2 of the study.

Sponsors & Collaborators

• South Tyneside and Sunderland NHS Foundation Trust: lead
• EvoEndo, Inc.: collaborator

Study Sites (1)

South Tyneside District Hospital

South Shields, Tyne and Wear, NE34 0PL, United Kingdom

Location

MeSH Terms

Conditions

Patient Satisfaction; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Phey Shen Lee

  South Tyneside and Sunderland NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: October 10, 2024
• Study Start: February 23, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)