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Virtual Reality (VR) to Reduce Preoperative Anxiety.

The Impact of Induced Hypnosis by Virtual Reality AQUA Module on Preoperative Anxiety.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03905915
Acronym
RVAQUA
Enrollment
50
Registered
2019-04-08
Start date
2019-02-26
Completion date
2019-12-31
Last updated
2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preoperative

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.

Interventions

DEVICEVirtual reality (VR) session with AQUA module

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

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Amsterdam preoperative anxiety and information score (APAIS) after VR session5 minutes after virtual reality sessionThe 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

MeasureTime frameDescription
Evaluation du Vécu de l'ANesthésie - LocoRégionale) EVAN-LR satisfaction score2 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 session5 minutes after the virtual reality sessionscore between 0 ( no anxious) and 10 (highly anxious)

Countries

Belgium

Contacts

Primary ContactFabienne Roelants, MD
fabienne.roelants@uclouvain.be+32 2 764 18 21

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026