N/A
N=31
Virtual Reality Alternative to Pharmacological Sedation During Colonoscopy
Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT04349150 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue — 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virtual reality (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Complete Colonoscopy Using Virtual Reality and no Pharmacological Rescue |
26 | — |
| PRIMARY Number of Participants With Cecal Intubation |
27 | — |
| SECONDARY Participant-reported Pain and Discomfort Levels |
3.6; 4.0 | — |
| SECONDARY Participant Satisfaction |
7.3 | — |
| SECONDARY Number of Participants Who Would Undergo Future Colonoscopies Using Virtual Reality and no Pharmacological Sedation |
18; 7; 1 | — |
| SECONDARY Endoscopist Satisfaction |
8.6 | — |
| SECONDARY Number of Endoscopies Following Which Endoscopists Indicated Willingness to Incorporate Virtual Reality Into Regular Colonoscopy Practice |
19; 0; 6 | — |
Summary
Colonoscopy patients will be fitted with a virtual reality head-mounted display, and virtual experiences will be initiated prior to colonoscope insertion. Colonoscopy will be initiated without standard sedatives and narcotics. The colonoscopy will proceed with the subject using virtual reality distraction instead of pharmacological sedation for as long as s/he would like. Standard sedatives and narcotics will be administered upon participant request at any time during the procedure. Questionnaires will be administered to the subject and the endoscopist after each procedure to assess the acceptability of use of virtual reality in the colonoscopy setting.
Eligibility Criteria
Inclusion Criteria
- Adult (18 years or older)
- Scheduled for screening or surveillance colonoscopy
- Has undergone at least 1 prior colonoscopy under conscious sedation
Exclusion Criteria
- Children (<18 years)
- Scheduled to undergo colonoscopy under general anesthesia
- Scheduled to undergo colonoscopy with no sedation
- First-time colonoscopy patients
- Scheduled for colonoscopy to assess symptoms or pre-existing disease
Data sourced from ClinicalTrials.gov (NCT04349150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.