Digital Sedation: Virtual Reality Hypnosis During Colonoscopy (COLDiS)

Oncomfort

Status: Terminated

Conditions: Colonoscopy

Treatments: Drug: Propofol; Device: Aqua© 30 on Oncomfort SedakitTM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04465383

OC08

Details and patient eligibility

About

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.

Full 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 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.

Participants will be recruited during the anesthesiology consultation conducted in preparation for colonoscopy. Those with indication for screening or diagnostic colonoscopy under conventional intravenous sedation (propofol) and willing to participate will provide their written informed consent and will be randomized (2:1) between two arms:

1. Experimental arm: Digital Sedation, with rescue intravenous sedation (propofol) if needed upon patient request
2. Control arm: conventional intravenous sedation (propofol)

The study will be divided into three stages, with randomization (2:1) maintained throughout. In the first stage, accrual will be halted when about 45 patients have been randomized, at least 27 of whom being evaluable patients randomized to the experimental arm. A non-binding futility analysis is planned for the primary outcome. In the second stage, accrual will be halted when about 90 patients have been randomized. A non-binding futility analysis is planned for the primary outcome. If the milestones are met, accrual will be reopened to the second stage and the study will continue to the planned final accrual of 177 patients (118 to experimental and 59 to control arm, respectively). At the end of the recruitment of Stage 1 and 2, an analysis of the secondary outcomes will also be run. Results of these analysis could also impact the decision for pursuing to second/ third stage.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Digital Sedation

Experimental group

Description:

Digital Sedation with rescue intravenous sedation (propofol) if needed upon patient request

Treatment:

Drug: Propofol

Device: Aqua© 30 on Oncomfort SedakitTM

Intravenous sedation

Active Comparator group

Description:

Control arm with conventional Intravenous sedation

Treatment:

Drug: Propofol