NCT04024904

Virtual Reality Hypnosis Distraction Utility to Improve Tolerance to Regional Anaesthesia

Completed NA Last updated 18 January 2022

What this trial tests

NA trial testing OncomfortTM device in Anesthesia in 60 participants. Completed in 30 November 2018.

Timeline

26 July 2018

Primary endpoint
30 November 2018

30 November 2018

Quick facts

Lead sponsor	Erasme University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	60
Start date	26 July 2018
Primary completion	30 November 2018
Estimated completion	30 November 2018
Sites	1 location across Belgium

Drugs / interventions tested

• OncomfortTM device

Conditions studied

• Anesthesia — all drugs for Anesthesia →

Sponsor

Erasme University Hospital

Who can join

18 and older, any sex, with Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.