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

Anxiety Clinical Trial

— AMBLUMEEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05590078
• Other study ID #: 69HCL20_0102
• Status: Completed
• Phase: N/A
• Start date: March 21, 2023
• Est. completion date: October 18, 2023

Study information

• Verified date: December 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: October 18, 2023
• Est. primary completion date: October 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• Virtual reality session
The 20-minute virtual reality session, in the outpatient department before surgery, immerses the patient in calm environments combined with music therapy and breathing exercises to relax and reduce anxiety.

Other:
• State Trait Anxiety Inventory
The State Trait Anxiety Inventory (State anxiety) is a questionnaire given to adults that shows how strong a person's feelings of anxiety are "right now, just now". The score is measured on arrival in the outpatient department and just before going into the intervention room (= after the virtual reality session for the experimental group)
• Virtual Reality Satisfaction Score
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session
• Perioperative care satisfaction score
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care

Locations

Country	Name	City	State
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Anxiety	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)	D0 : baseline and right before going to surgery
Secondary	Number of milligrams of midazolam administered	Comparison of midazolam premedication to reduce preoperative anxiety between control group and virtual reality group.	D0 (before surgery)
Secondary	Percentage of patients with intraoperative remifentanil required	Comparison in term of Number of case where the utilisation of remifentanil was necessary in peroperative between control group and virtual reality group.	D0 (during surgery)
Secondary	Pain score	Pain assessment with numerical scale from 0 (low) to 10(high)	D0 (after surgery)
Secondary	Morphine dose used	Comparison of morphine dose used in recovery room between control group and virtual reality group	D0 (after surgery in recovery room)
Secondary	Perioperative care satisfaction score	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	through study completion, 1 day
Secondary	Nature and severity of adverse events	Comparison of adverse event during hospitalization between control group and virtual reality group	through study completion, 1 day
Secondary	Adverse events related to the virtual reality session	Nature and severity of adverse events related to the virtual reality session	through study completion, 1 day
Secondary	Virtual Reality Satisfaction Score	Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session. 5 items scored from 0 (low) to 10 (high)	through study completion, 1 day
Secondary	Experience of the caregiver	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)	D0 (before surgery)