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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Other: State Trait Anxiety Inventory; Other: Perioperative care satisfaction score; Device: Virtual reality session; Other: Virtual Reality Satisfaction Score

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France
    • Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; General routine care. This group will undergo to ambulatory surgery without preoperative virtual reality session. Will be applied the usual treatment to reduce preoperative 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); Other: Perioperative care satisfaction score; Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care
Experimental: Virtual reality group; Virtual Reality. This group will undergo to 20 min virtual reality before ambulatory surgery. In addition to virtual reality session, will be applied the usual treatment to reduce preoperative anxiety, after virtual reality, if necessary.	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); Other: Perioperative care satisfaction score; Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care; 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: Virtual Reality Satisfaction Score; Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of milligrams of midazolam administered	Comparison of midazolam premedication to reduce preoperative anxiety between control group and virtual reality group.	D0 (before surgery)
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)
Pain score	Pain assessment with numerical scale from 0 (low) to 10(high)	D0 (after surgery)
Morphine dose used	Comparison of morphine dose used in recovery room between control group and virtual reality group	D0 (after surgery in recovery room)
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
Nature and severity of adverse events	Comparison of adverse event during hospitalization between control group and virtual reality group	through study completion, 1 day
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
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
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)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Arnaud FRIGGERI, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Actual): October 18, 2023
• Study Completion (Actual): October 18, 2023

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: anxiety; Virtual reality; preoperative anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 69HCL20_0102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No