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

Not Applicable

Completed

• Conditions: Anxiety

• Registration Number: NCT05590078
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-14
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Study Start: 2023-03-21
• Primary Completion: 2023-10-18
• Study Completion: 2023-10-18
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of Anxiety	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 Outcome Measures

Name	Time	Method
Number of milligrams of midazolam administered	D0 (before surgery)	Comparison of midazolam premedication to reduce preoperative anxiety between control group and virtual reality group.
Pain score	D0 (after surgery)	Pain assessment with numerical scale from 0 (low) to 10(high)
Virtual Reality Satisfaction Score	through study completion, 1 day	Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session. 5 items scored from 0 (low) to 10 (high)
Adverse events related to the virtual reality session	through study completion, 1 day	Nature and severity of adverse events related to the virtual reality session
Percentage of patients with intraoperative remifentanil required	D0 (during surgery)	Comparison in term of Number of case where the utilisation of remifentanil was necessary in peroperative between control group and virtual reality group.
Perioperative care satisfaction score	through study completion, 1 day	Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care. 5 answer possible :Very satisfied - satisfied- Neither satisfied nor unsatisfied- Unsatisfied - Very unsatisfied
Experience of the caregiver	D0 (before surgery)	Experience of the caregiver concerning the implementation of virtual reality in the outpatient department before surgery . 2 items scored from 0 (low) to 10 (high)
Morphine dose used	D0 (after surgery in recovery room)	Comparison of morphine dose used in recovery room between control group and virtual reality group
Nature and severity of adverse events	through study completion, 1 day	Comparison of adverse event during hospitalization between control group and virtual reality group

Trial Locations

Locations (1)

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France