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

Hospices Civils de Lyon106 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Anxiety

Interventions

Virtual reality sessionDEVICE

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.

State Trait Anxiety InventoryOTHER

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 ScoreOTHER

Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

Number of milligrams of midazolam administered

Comparison of midazolam premedication to reduce preoperative anxiety between control group and virtual reality group.

Time frame: 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.

Time frame: D0 (during surgery)

Pain score

Pain assessment with numerical scale from 0 (low) to 10(high)

Time frame: D0 (after surgery)

Morphine dose used

Comparison of morphine dose used in recovery room between control group and virtual reality group

Time frame: 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

Time frame: through study completion, 1 day

Nature and severity of adverse events

Comparison of adverse event during hospitalization between control group and virtual reality group

Data from ClinicalTrials.gov

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