Virtual Reality (VR) to Reduce Preoperative Anxiety.

Cliniques universitaires Saint-Luc- Université Catholique de Louvain50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Preoperative

Interventions

Virtual reality (VR) session with AQUA moduleDEVICE

A device with virtual reality is given to the patients with a film of 15 minutes

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cliniques universitaires Saint-luc

Brussels, Belgium

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: 5 minutes after virtual reality session

Secondary Outcomes

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).

Time frame: 2 hours after VR session (in the recovery room, after surgery)

Change of Visual Analog Score (VAS) anxiety score after VR session

score between 0 ( no anxious) and 10 (highly anxious)

Time frame: 5 minutes after the virtual reality session

Central Contacts

Fabienne Roelants, MD

CONTACT

+32 2 764 18 21 fabienne.roelants@uclouvain.be

Data from ClinicalTrials.gov

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