Virtual Reality (VR) to Reduce Preoperative Anxiety.

NCT ID: NCT03905915

Last Updated: 2019-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-26

Study Completion Date

2019-12-31

Brief Summary

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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

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Conditions

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Preoperative

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Virtual reality (VR) session with AQUA module

Intervention Type DEVICE

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

Interventions

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Virtual reality (VR) session with AQUA module

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Roelants

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roelants Fabienne, MD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques universitaires Saint-luc

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Fabienne Roelants, MD

Role: CONTACT

+32 2 764 18 21

Facility Contacts

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Fabienne Roelants, MD

Role: primary

+3227641821

Nassim Touil, MD

Role: backup

+3227641821

References

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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.

Reference Type RESULT
PMID: 27375388 (View on PubMed)

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.

Reference Type RESULT
PMID: 26021790 (View on PubMed)

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.

Reference Type RESULT
PMID: 29317347 (View on PubMed)

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.

Reference Type RESULT
PMID: 23221859 (View on PubMed)

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.

Reference Type RESULT
PMID: 24099176 (View on PubMed)

Other Identifiers

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2016/20JUL/345

Identifier Type: -

Identifier Source: org_study_id

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