Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

Study Overview
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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.

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.

Official Title
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Use of Virtual Reality Technology as a Sedation Replacement During Colonoscopy

Conditions
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Patient Satisfaction

Intervention / Treatment
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* Device: virtual reality headset
* Other: colonoscopy with standard sedation.


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pilot randomized controled study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual reality group<br>unsedated colonoscopy using virtual reality headset. | Device: virtual reality headset<br>* use of virtual reality headset during colonoscopy as a substitute to sedation.<br>|
| Active Comparator: colonoscopy with standard sedation<br>standard sedated colonoscopy. | Other: colonoscopy with standard sedation.<br>* use of standard sedation during colonoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during the procedure | Questionnaire (1- severe pain, 5 - no pain at all) | 1 day | 
| polyp detection rate (PDR) | number of polyps detected during colonoscopy | during colonoscopy procedure | 
| Colonoscopy duration | in minutes starting at insertion of the colonoscope to the anus until final withdrawal | during colonoscopy procedure | 
| Post colonoscopy adverse events | 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) | 1 day | 
| Time-to-return to daily activities (work, driving) | hours | 1 day | 
| Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit) | overall time at the unit | 1 day |