Virtual Reality (VR) to Reduce Preoperative Anxiety. (RVAQUA)
April 4, 2019 updated by: Roelants, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
The Impact of Induced Hypnosis by Virtual Reality AQUA Module on Preoperative Anxiety.
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Brussels, Belgium, 1200
- Recruiting
- Cliniques Universitaires Saint-Luc
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Contact:
- Fabienne Roelants, MD
- Phone Number: +3227641821
- Email: fabienne.roelants@uclouvain.be
-
Contact:
- Nassim Touil, MD
- Phone Number: +3227641821
- Email: nassim.touil@uclouvain.be
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Preoperative virtual reality session
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
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A device with virtual reality is given to the patients with a film of 15 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Amsterdam preoperative anxiety and information score (APAIS) after VR session
Time Frame: 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).
|
5 minutes after virtual reality session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation du Vécu de l'ANesthésie - LocoRégionale) EVAN-LR satisfaction score
Time Frame: 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).
|
2 hours after VR session (in the recovery room, after surgery)
|
|
Change of Visual Analog Score (VAS) anxiety score after VR session
Time Frame: 5 minutes after the virtual reality session
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score between 0 ( no anxious) and 10 (highly anxious)
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5 minutes after the virtual reality session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Roelants Fabienne, MD, Cliniques Universitaires Saint-Luc
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 26, 2019
Primary Completion (Anticipated)
December 31, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
March 26, 2019
First Submitted That Met QC Criteria
April 4, 2019
First Posted (Actual)
April 8, 2019
Study Record Updates
Last Update Posted (Actual)
April 8, 2019
Last Update Submitted That Met QC Criteria
April 4, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 2016/20JUL/345
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.