Digital Sedation: Virtual Reality Hypnosis During Colonoscopy

NCT ID: NCT04465383

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2021-12-21

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 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.

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 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.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Digital Sedation

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

Group Type: EXPERIMENTAL

Aqua© 30 on Oncomfort SedakitTM

Intervention Type: DEVICE

Digital Sedation session consists in a virtual reality software (Aqua© 30 Version 3.0, Oncomfort SA, Waver, Belgium) including a clinical hypnosis script.Patients in the intervention group will undergo a 30-minute Digital Sedation program through a VR headset and headphones. This medical device called Oncomfort SedakitTM has been created to reduce anxiety and pain during medical/ surgical interventions

Propofol

Intervention Type: DRUG

Standard sedation starting doses of 1 µg/ml to 6 µg/ml depending on patient's reaction and titrated incrementally by 0.5µg/ml. Doses are adapted according to the level of comfort and needs of the patient.

Intravenous sedation

Control arm with conventional Intravenous sedation

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

Standard sedation starting doses of 1 µg/ml to 6 µg/ml depending on patient's reaction and titrated incrementally by 0.5µg/ml. Doses are adapted according to the level of comfort and needs of the patient.

Interventions

Aqua© 30 on Oncomfort SedakitTM

Digital Sedation session consists in a virtual reality software (Aqua© 30 Version 3.0, Oncomfort SA, Waver, Belgium) including a clinical hypnosis script.Patients in the intervention group will undergo a 30-minute Digital Sedation program through a VR headset and headphones. This medical device called Oncomfort SedakitTM has been created to reduce anxiety and pain during medical/ surgical interventions

Intervention Type: DEVICE

Propofol

Standard sedation starting doses of 1 µg/ml to 6 µg/ml depending on patient's reaction and titrated incrementally by 0.5µg/ml. Doses are adapted according to the level of comfort and needs of the patient.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: collaborator

Oncomfort

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Blero, Prof. MD.

Role: PRINCIPAL_INVESTIGATOR

H.U.B Erasme

Locations

Hôpital Erasme

Brussels, , Belgium

Countries

Belgium

Other Identifiers

OC08

Identifier Type: -

Identifier Source: org_study_id