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Clinical Trials/NCT05701566
NCT05701566
Recruiting
Not Applicable

Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

Sheba Medical Center1 site in 1 country60 target enrollmentJune 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patient Satisfaction
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.
Status
Recruiting
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2022
End Date
December 1, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

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

  • Pain during the procedure(1 day)
  • polyp detection rate (PDR)(during colonoscopy procedure)
  • Colonoscopy duration(during colonoscopy procedure)
  • Post colonoscopy adverse events(1 day)
  • Time-to-return to daily activities (work, driving)(1 day)
  • Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit)(1 day)

Study Sites (1)

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