Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery (ERVAN)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Enrolling

Conditions: Refractive Disorders

Treatments: Procedure: Usual Care Group; Device: Virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT07050498

2023-A01771-44

Details and patient eligibility

About

The objective of this study is to determine to what extent the use of a software application prior to refractive surgery involving multisensory immersion (visual and auditory) in a hypnotic and relaxing sound and visual environment can reduce anxiety levels.

The assessment of preoperative anxiety levels will be based on the administration of a psychometric scale (APAIS scale) and the measurement of salivary cortisol, which is a sensitive marker of the patient's stress level.

Full description

This is a prospective, randomized, open-label, single-center study conducted on two parallel groups of patients undergoing refractive surgery (virtual reality preoperative conditioning or routine preoperative procedure). Therapeutic benefit is based on the assessment of preoperative anxiety using the APAIS scale.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged 18 years or older,
• Patient who has read and signed the consent form for participation in the study after a reflection period (between 10 and 45 minutes)
• Patient who is a candidate for refractive surgery

Exclusion criteria

• Contraindication to virtual reality (uncontrolled epilepsy, hearing impairment)
• Pregnant or breastfeeding patient
• Cushing's disease, Addison's disease, hypo- or hyperthyroidism
• Patient treated with topical or systemic corticosteroids
• Patient treated with neuroleptics, anxiolytics, or antidepressants
• Patient under legal protection, guardianship, or curatorship
• Patient participating in another blinded research study
• Patient not affiliated with the French social security system
• Patient unable to understand the information provided and/or give written informed consent: dementia, psychosis, impaired consciousness, non-French-speaking patient

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Virtual reality

Experimental group

Description:

Preoperative conditioning by virtual reality + Routine preoperative procedure (local anesthesia)

Treatment:

Device: Virtual reality

Usual care

Active Comparator group

Description:

Routine preoperative procedure (local anesthesia)

Treatment:

Procedure: Usual Care Group