Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sheba Medical Center
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy.
Study Overview
Brief Summary
A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination.
Detailed Description
VR is an attention-distracting technology via visual and auditory signals by a computer-generated virtual engulfing environment. This technology has already been used in a variety of medical conditions and previous studies have demonstrated the benefit of using it as an additional tool for pain relief and as a substitute to sedation in invasive procedure. In this study we examined the use of VR as a substitute for sedation in colonoscopy. In this randomized control study, 60 patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure. The primary outcome was the overall satisfaction of patients who underwent unsedated colonoscopy with VR headset compared with patients who underwent standard sedation colonoscopy. Pain during the procedure, PDR, colonoscopy duration, post colonoscopy adverse events, post colonoscopy recovery and time-to-return to daily functions and turnaround time at the endoscopy unit were secondary outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •adult patients (≥18) with any elective indication for colonoscopy.
Exclusion Criteria
- •known seizures' disorders, cognitive, visual or auditory impairment.
- •patients who were unable or unwilling to sign an informed consent.
- •Pregnant women.
Arms & Interventions
virtual reality group
unsedated colonoscopy using virtual reality headset.
Intervention: virtual reality headset (Device)
colonoscopy with standard sedation
standard sedated colonoscopy.
Intervention: colonoscopy with standard sedation. (Other)
Outcomes
Primary Outcomes
Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy.
Time Frame: 1 day
Questionnaire (1 - not satisfied at all, 5 - very satisfied)
Secondary Outcomes
- Time-to-return to daily activities (work, driving)(1 day)
- Pain during the procedure(1 day)
- polyp detection rate (PDR)(during colonoscopy procedure)
- Colonoscopy duration(during colonoscopy procedure)
- Post colonoscopy adverse events(1 day)
- Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit)(1 day)