Anxiety
Conditions
Keywords
Virtual reality, preoperative anxiety, anxiety
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.
Interventions
DEVICEVirtual 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.
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)
OTHERVirtual Reality Satisfaction Score
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding virtual reality session
OTHERPerioperative care satisfaction score
Likert scale satisfaction questionnaire to collect the patients' satisfaction regarding perioperative care
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Anxiety | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with intraoperative remifentanil required | 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. |
| Pain score | D0 (after surgery) | Pain assessment with numerical scale from 0 (low) to 10(high) |
| Morphine dose used | D0 (after surgery in recovery room) | Comparison of morphine dose used in recovery room between control group and virtual reality group |
| Perioperative care satisfaction score | 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 |
| Number of milligrams of midazolam administered | D0 (before surgery) | Comparison of midazolam premedication to reduce preoperative anxiety between control group and virtual reality group. |
| Adverse events related to the virtual reality session | through study completion, 1 day | Nature and severity of adverse events related to the virtual reality session |
| Virtual Reality Satisfaction Score | 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) |
| Experience of the caregiver | 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) |
| Nature and severity of adverse events | through study completion, 1 day | Comparison of adverse event during hospitalization between control group and virtual reality group |
Countries
France
Outcome results
None listed