Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery

Hospices Civils de Lyon1 site in 1 country106 target enrollmentMarch 21, 2023

ConditionsAnxiety

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety
Sponsor: Hospices Civils de Lyon
Enrollment: 106
Locations: 1
Primary Endpoint: Change of Anxiety
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study evaluate the interest of Virtual Reality to reduce the preoperative anxiety in patients who undergo to ambulatory surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.

Registry

clinicaltrials.gov

Start Date

March 21, 2023

End Date

October 18, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•ASA I-II (classification of the American Society of Anesthesiologists).
•Ambulatory surgery scheduled
•Score STAI YA \> 45
•Affiliated to a social security
•Understanding the study and signing the informed consent

Exclusion Criteria

•Contraindications for Midazolam
•Patients with disorders not compatible with virtual reality: severe cognitive or psychiatric disorders, blindness, claustrophobia, epilepsy
•Patient with a pacemaker of others implantable medical devices
•patient with burns or wounds on the upper face or scalp
•Visual hallucinations
•Contagious disease by air or indirect contact
•Person unable to express their consent
•Minor patient or patient under curatorship or guardianship
•patient participating in another interventional clinical trial

Outcomes

Primary Outcomes

Change of Anxiety

Time Frame: D0 : baseline and right before going to surgery

Measured by State-Trait Anxiety Inventory (STAI YA) . The scale includes twenty items.. Each question is assigned 1 to 4 points, giving a score of 20 (low anxiety) to 80 points (high anxiety)

Secondary Outcomes

Number of milligrams of midazolam administered(D0 (before surgery))
Pain score(D0 (after surgery))
Virtual Reality Satisfaction Score(through study completion, 1 day)
Adverse events related to the virtual reality session(through study completion, 1 day)
Percentage of patients with intraoperative remifentanil required(D0 (during surgery))
Perioperative care satisfaction score(through study completion, 1 day)
Experience of the caregiver(D0 (before surgery))
Morphine dose used(D0 (after surgery in recovery room))
Nature and severity of adverse events(through study completion, 1 day)