Status:
TERMINATED
Digital Sedation: Virtual Reality Hypnosis During Colonoscopy
Lead Sponsor:
Oncomfort
Collaborating Sponsors:
Erasme University Hospital
Conditions:
Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the...
Detailed Description
This prospective Randomized Controlled Trial will evaluate efficacy, safety, and pharmacoeconomic outcomes in patients undergoing colonoscopy with either Digital Sedation using the Aqua© module of the...
Eligibility Criteria
Inclusion
- Age of 18 years or older
- Indication for screening or diagnostic colonoscopy under conventional IVS (propofol)
- Provision of written informed consent
Exclusion
- Scheduled dilation
- Active Crohn Disease
- Low auditory acuity that precludes use of the device
- Low visual acuity that precludes use of the device
- Head or face wounds precluding use of the device
- Schizophrenia
- Dizziness
- Water/sea phobia
- Non-proficiency in French or Dutch (research language)
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04465383
Start Date
June 25 2020
End Date
December 21 2021
Last Update
October 3 2022
Active Locations (1)
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1
Hôpital Erasme
Brussels, Belgium, 1070