Virtual Reality (VR) to Reduce Preoperative Anxiety.

Preoperative Clinical Trial

— RVAQUA  

Official title:

The Impact of Induced Hypnosis by Virtual Reality AQUA Module on Preoperative Anxiety.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03905915
• Other study ID #: 2016/20JUL/345
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Fabienne Roelants, MD
• Phone: +32 2 764 18 21
• Email: fabienne.roelants[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Preoperative

Intervention

Device:
• Virtual reality (VR) session with AQUA module
A device with virtual reality is given to the patients with a film of 15 minutes

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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):257-2 — View 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. — View 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. — View 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. — View Citation

Scavée V, Dehullu JP, Scavée 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Amsterdam preoperative anxiety and information score (APAIS) after VR session	The Amsterdam preoperative anxiety and information (APAIS) scale is a 6-items questionnaire. Each item is scored from 1(not at all) to 5(extremely). 4 items assess anxiety (patient with a score >or = to 11 is considered very anxious), 2 items assess the desire for information (patient with a score > 8 is considered very anxious because there is a corelation between need for informa tion and anxiety). The score ranges from 6 (no anxious) to 30 (highly anxious).	5 minutes after virtual reality session
Secondary	Evaluation du Vécu de l'ANesthésie - LocoRégionale) EVAN-LR satisfaction score	Evaluation du Vécu de l'Anesthésie LocoRégionale (EVAN-LR) is a tool assessing patient satisfaction within the perioperative period surrounding regional anesthesia. The EVAN-LR comprises 19 items, structured in a global index and five dimensions: Attention, Information, Discomfort, Waiting, and Pain. Each item is scored from 1(not at all) to 5(extremely). The score ranges from 18(no satisfied) to 95 (highly satisfied).	2 hours after VR session (in the recovery room, after surgery)
Secondary	Change of Visual Analog Score (VAS) anxiety score after VR session	score between 0 ( no anxious) and 10 (highly anxious)	5 minutes after the virtual reality session