Clinical trial NCT03905915: Virtual Reality (VR) to Reduce Preoperative Anxiety.
Official title: The Impact of Induced Hypnosis by Virtual Reality AQUA Module on Preoperative Anxiety.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preoperative
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Most patients awaiting surgery show significant anxiety score which can be influenced by the fear of anesthesia or surgery but also by the context of care. These anxious patients will have more postoperative complications and can also develop chronic pain. The Virtual reality AQUA module induces hypnosis and is specially designed to reduce anxiety. The purpose of the study is to examine the effect of a virtual reality session on preoperative anxiety.


Eligibility criteria: Inclusion Criteria:

* patients undergoing scheduled orthopedic surgery with loco-regional anesthesia at Saint-Luc Hospital.
* Patients not following long-term psychotherapeutic treatment
* Patients not taking psychotropic medication
* free, informed and written consent signed by the investigator and the patient before the procedure.

Exclusion Criteria:

* patient not speaking French
* Patients with long-term psychotherapeutic treatment
* Patients taking psychotropic drugs
* patient blind and deaf

Primary outcomes:
measure: Change of Amsterdam preoperative anxiety and information score (APAIS) after VR session
timeFrame: 5 minutes after virtual reality session
Secondary outcomes:
measure: Evaluation du Vécu de l'ANesthésie - LocoRégionale) EVAN-LR satisfaction score
timeFrame: 2 hours after VR session (in the recovery room, after surgery)
measure: Change of Visual Analog Score (VAS) anxiety score after VR session
timeFrame: 5 minutes after the virtual reality session
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Roelants Fabienne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruhaiyem ME, Alshehri AA, Saade M, Shoabi TA, Zahoor H, Tawfeeq NA. Fear of going under general anesthesia: A cross-sectional study. Saudi J Anaesth. 2016 Jul-Sep;10(3):317-21. doi: 10.4103/1658-354X.179094.
citation: Scavee V, Dehullu JP, Scavee JP, Michel I. Impact of Anxiety in Ambulatory Superficial Venous Surgery : A Prospective Study Using the HADS-A Scale. Acta Chir Belg. 2015 Jan-Feb;115:42-8.
citation: Ganry L, Hersant B, Sidahmed-Mezi M, Dhonneur G, Meningaud JP. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery. J Stomatol Oral Maxillofac Surg. 2018 Sep;119(4):257-261. doi: 10.1016/j.jormas.2017.12.010. Epub 2018 Jan 6.
citation: Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.
citation: Maurice-Szamburski A, Loundou A, Capdevila X, Bruder N, Auquier P. Validation of the French version of the Amsterdam preoperative anxiety and information scale (APAIS). Health Qual Life Outcomes. 2013 Oct 7;11:166. doi: 10.1186/1477-7525-11-166.