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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| virtual reality group | Experimental | unsedated colonoscopy using virtual reality headset. |
|
| colonoscopy with standard sedation | Active Comparator | standard sedated colonoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| virtual reality headset | Device | use of virtual reality headset during colonoscopy as a substitute to sedation. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ido Veisman, Dr. | Contact | +97235307072 | 7072 | Ido.Veisman@sheba.health.gov.il |
| Revital Dvir, Mrs. | Contact | +97235307072 | revital.dvir@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Ido Veisman, Dr. | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology department, Sheba Medical Center | Recruiting | Tel Litwinsky | Israel |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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pilot randomized controled study
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| colonoscopy with standard sedation. | Other | use of standard sedation 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 |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |