Digital Sedation: Virtual Reality Hypnosis During Colonoscopy

NCT04465383 | Terminated

• 1 other identifier: OC08
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (2)

• To confirm the feasibility of using digital sedation in colonoscopy (stage 1)

  cecal intubation rate, rate of rescue sedation

  Day 1

• To demonstrate adequate performance of colonoscopy using digital sedation (stage 2)

  cecal intubation rate, rate of rescue sedation

  Day 1

Secondary Outcomes (9)

• To compare patient experience in both arms

  Day 1 & Day 2 Follow-up call

• To compare measures of colonoscopy performance in both arms

  Day 1

• To assess the need for rescue sedation in the experimental arm

  Day 1

• To compare use of sedation medication in both arms

  Day 1

• To assess gastroenterologist and anesthesiologist satisfaction in both arms

  Day 1

Study Arms (2)

Digital Sedation

EXPERIMENTAL

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

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

Intravenous sedation

ACTIVE COMPARATOR

Control arm with conventional Intravenous sedation

Drug: Propofol

Interventions

Aqua© 30 on Oncomfort SedakitTM 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

Digital Sedation

Propofol 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.

Digital Sedation; Intravenous sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years or older
• Indication for screening or diagnostic colonoscopy under conventional IVS (propofol)
• Provision of written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Oncomfort: lead
• Erasme University Hospital: collaborator

Study Sites (1)

Hôpital Erasme

Brussels, 1070, Belgium

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Daniel Blero, Prof. MD.

  Erasme University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 10, 2020
• Study Start: June 25, 2020
• Primary Completion: September 20, 2021
• Study Completion: December 21, 2021
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)