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Digital Sedation: Virtual Reality Hypnosis During Colonoscopy

NCT04465383 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-10-03

No results posted yet for this study

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

Interventions

DEVICE

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

DRUG

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.

Sponsors & Collaborators

  • Erasme University Hospital

    collaborator OTHER

  • Oncomfort

    lead INDUSTRY

Principal Investigators

  • Daniel Blero, Prof. MD. · H.U.B Erasme

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2021-09-20
Completion
2021-12-21

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04465383 on ClinicalTrials.gov