Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

Sheba Medical Center

Status: Enrolling

Conditions: Patient Satisfaction

Treatments: Other: colonoscopy with standard sedation.; Device: virtual reality headset

Study type: Interventional

Funder types: Other

Identifiers

NCT05701566

8177-21-IV-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

virtual reality group

Experimental group

Description:

unsedated colonoscopy using virtual reality headset.

Treatment:

Device: virtual reality headset

colonoscopy with standard sedation

Active Comparator group

Description:

standard sedated colonoscopy.

Treatment:

Other: colonoscopy with standard sedation.