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Completed

NCT Number: NCT05590078

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

Virtual Reality Satisfaction Score

Other

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

Perioperative care satisfaction score

Other

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

Primary outcomes

  1. Change of Anxiety

    Time frame: 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 outcomes

  1. Number of milligrams of midazolam administered

    Time frame: D0 (before surgery)

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

  2. Percentage of patients with intraoperative remifentanil required

    Time frame: 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.

  3. Pain score

    Time frame: D0 (after surgery)

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

  4. Morphine dose used

    Time frame: D0 (after surgery in recovery room)

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

  5. Perioperative care satisfaction score

    Time frame: 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

  6. Nature and severity of adverse events

    Time frame: through study completion, 1 day

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

  7. Adverse events related to the virtual reality session

    Time frame: through study completion, 1 day

    Nature and severity of adverse events related to the virtual reality session

  8. Virtual Reality Satisfaction Score

    Time frame: 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)

  9. Experience of the caregiver

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: AMBLUMEEN

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 21, 2022
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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