Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Patient Satisfaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

pilot randomized controled study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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virtual reality group

unsedated colonoscopy using virtual reality headset.

Group Type EXPERIMENTAL

virtual reality headset

Intervention Type DEVICE

use of virtual reality headset during colonoscopy as a substitute to sedation.

colonoscopy with standard sedation

standard sedated colonoscopy.

Group Type ACTIVE_COMPARATOR

colonoscopy with standard sedation.

Intervention Type OTHER

use of standard sedation during colonoscopy.

Interventions

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virtual reality headset

use of virtual reality headset during colonoscopy as a substitute to sedation.

Intervention Type DEVICE

colonoscopy with standard sedation.

use of standard sedation during colonoscopy.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes