Virtual Reality (VR) to Reduce Preoperative Anxiety.

NCT03905915 | Unknown

• 1 other identifier: 2016/20JUL/345
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation du Vécu de l'ANesthésie - LocoRégionale) EVAN-LR satisfaction score

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

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

  5 minutes after the virtual reality session

Study Arms (1)

Preoperative virtual reality session

OTHER

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

Device: Virtual reality (VR) session with AQUA module

Interventions

Virtual reality (VR) session with AQUA module DEVICE

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

Preoperative virtual reality session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (5)

• 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.

  PMID: 27375388 RESULT

• 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.

  PMID: 26021790 RESULT

• 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.

  PMID: 29317347 RESULT

• 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.

  PMID: 23221859 RESULT

• 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.

  PMID: 24099176 RESULT

Study Officials

• Roelants Fabienne, MD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabienne Roelants, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 8, 2019
• Study Start: February 26, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)