Virtual Reality (VR) to Reduce Preoperative Anxiety.

Not Applicable

• Conditions: Preoperative
• Interventions: Device: Virtual reality (VR) session with AQUA module

• Registration Number: NCT03905915
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-26
• Study First Submitted: 2019-03-26
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-04
• Last Update Submitted: 2019-04-04
• Study First Posted: 2019-04-08
• Last Update Posted: 2019-04-08
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preoperative virtual reality session	Virtual reality (VR) session with AQUA module	Amsterdam Anxiety score recorded before VR session is followed by a 15 min VR session and finally Amsterdam Anxiety score is recorded after VR session

Primary Outcome Measures

Name	Time	Method
Change of Amsterdam preoperative anxiety and information score (APAIS) after VR session	5 minutes after virtual reality 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).

Secondary Outcome Measures

Name	Time	Method
Evaluation du Vécu de l'ANesthésie - LocoRégionale) EVAN-LR satisfaction score	2 hours after VR session (in the recovery room, after surgery)	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).
Change of Visual Analog Score (VAS) anxiety score after VR session	5 minutes after the virtual reality session	score between 0 ( no anxious) and 10 (highly anxious)

Trial Locations

Locations (1)

Cliniques universitaires Saint-luc; 🇧🇪 Brussels, Belgium