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

NCT05590078 | Completed

• 1 other identifier: 69HCL20_0102
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Virtual reality; preoperative anxiety; anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of milligrams of midazolam administered

  D0 (before surgery)

• Percentage of patients with intraoperative remifentanil required

  D0 (during surgery)

• Pain score

  D0 (after surgery)

• Morphine dose used

  D0 (after surgery in recovery room)

• Perioperative care satisfaction score

  through study completion, 1 day

Study Arms (2)

Control group

OTHER

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; Other: Perioperative care satisfaction score

Virtual reality group

EXPERIMENTAL

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.

Device: Virtual reality session; Other: State Trait Anxiety Inventory; Other: Virtual Reality Satisfaction Score; Other: Perioperative care satisfaction score

Interventions

Virtual reality session DEVICE

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.

Virtual reality group

State Trait Anxiety Inventory OTHER

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)

Control group; Virtual reality group

Virtual Reality Satisfaction Score OTHER

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

Virtual reality group

Perioperative care satisfaction score OTHER

Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care

Control group; Virtual reality group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Arnaud FRIGGERI

  Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 21, 2022
• Study Start: March 21, 2023
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)