Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

Not Applicable

Recruiting

• Conditions: Patient Satisfaction
• Interventions: Other: colonoscopy with standard sedation.; Device: virtual reality headset

• Registration Number: NCT05701566
• Lead Sponsor: Sheba Medical Center

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 Timeline

• Study Start: 2022-06-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-18
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-01-27
• Primary Completion: 2023-02-01
• Last Update Submitted: 2023-04-06
• Last Update Posted: 2023-04-10
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
colonoscopy with standard sedation	colonoscopy with standard sedation.	standard sedated colonoscopy.
virtual reality group	virtual reality headset	unsedated colonoscopy using virtual reality headset.

Primary Outcome Measures

Name	Time	Method
Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy.	1 day	Questionnaire (1 - not satisfied at all, 5 - very satisfied)

Secondary Outcome Measures

Name	Time	Method
Pain during the procedure	1 day	Questionnaire (1- severe pain, 5 - no pain at all)
polyp detection rate (PDR)	during colonoscopy procedure	number of polyps detected during colonoscopy
Colonoscopy duration	during colonoscopy procedure	in minutes starting at insertion of the colonoscope to the anus until final withdrawal
Post colonoscopy adverse events	1 day	Questionnaire: Did you suffer from a general bad feeling after the test, including dizziness, nausea, abdominal pain (1 - no complaints at all, 5 - serious complaints)
Time-to-return to daily activities (work, driving)	1 day	hours
Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit)	1 day	overall time at the unit

Trial Locations

Locations (1)

Gastroenterology department, Sheba Medical Center; 🇮🇱 Tel HaShomer, Israel