CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
OncomfortTM devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04024904
NCT04024904N/ACompleted

Virtual Reality Hypnosis Distraction Utility to Improve the Quality of Routine Procedure-related Pain During Preoperative Locoregional Anaesthesia

Erasme University Hospital·interventional·Posted Jul 18, 2019·Updated Jan 18, 2022

In Brief

A clinical study evaluating OncomfortTM device for Anesthesia. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Regional anaesthesia has many advantages but it might be a stressful and painful experience. Usually, the anesthetist administers a pharmacologic intravenous sedation to achieve patient's comfort. Though, these medications are not benign, and disadvantages include unpredictable response, adverse effects, and interference with cooperation. The virtual reality hypnosis distraction (VRHD) could be a good non-pharmacological technique to improve patient's comfort, decrease anxiety and procedure related pain. This study is a prospective study where sixty patients scheduled for orthopedic surgery requiring regional anesthesia were randomized in three groups according to the use or not of VRHD during the regional procedure or before as a complementary premedication. The anesthetic management during the regional procedure and the surgery remained otherwise standard for each patient. The first endpoint is the proportion of patients receiving pharmacological sedation (in the VRHD groups compared to the pharmacological sedation group). . The second endpoint is to determine if the VRHD increases the patient's satisfaction of their anaesthetic management. The third endpoint is to study various parameters of use of this specific anaesthetic management: time required for the installation and operation time of the VRHD device; the variation of haemodynamic parameters between the separate groups; pain procedure-related and behavioural pain scale scores between the separate groups.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnesthesia
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 18, 2019
Enrollment StartJul 26, 2018
Primary CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.0 years ago

Interventions

OncomfortTM devicedevice

The VHRD (Virtual Reality Hypnosis Distraction) technique is the program of OncomfortTM (Oncomfort Inc, Houston, USA). The OncomfortTM device include the hyper vision 3D virtual reality glasses and disposable single-patient-use headphones. The program is an immersive experience focused on inducing relaxation environment and this program exist in 5,15 and 30 minutes