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

Civil Hospices of Lyon

Status: Completed

Conditions: Anxiety

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05590078

69HCL20_0102

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Control group

Other group

Description:

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.

Treatment:

Other: State Trait Anxiety Inventory

Other: Perioperative care satisfaction score

Virtual reality group

Experimental group

Description:

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.

Treatment:

Other: Virtual Reality Satisfaction Score

Other: State Trait Anxiety Inventory

Other: Perioperative care satisfaction score

Device: Virtual reality session