Digital Sedation: Virtual Reality Hypnosis During Colonoscopy

• Status: Recruiting
• Trial end date: 2021-11-20
• Target enrollment: 0
• Participant gender: All

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 Oncomfort device (Sedakit TM) or the standard of care, intravenous sedation with propofol. The Aqua© module is designed for sedation and management of pain and anxiety related to medical and surgical procedures.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oncomfort
• Collaborator: Erasme University Hospital
• Treatments: Propofol

Criteria

Inclusion Criteria:

• Age of 18 years or older

• Indication for screening or diagnostic colonoscopy under conventional IVS (propofol)

• Provision of written informed consent

Exclusion Criteria:

• 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)