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

Not Applicable

Recruiting

• Conditions: Refractive Disorders

• Registration Number: NCT07050498
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2024-09-18
• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Primary Completion: 2026-09-18
• Study Completion: 2026-09-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Preoperative anxiety level	Preoperative procedure	The preoperative anxiety level is measured on the APAIS scale. The APAIS scale is a self-assessment consisting of six questions with expected responses rated from 1 (the patient strongly disagrees with the statement) to 5 (the patient strongly agrees with the statement) out of a minimum overall score of 6 and a maximum overall score of 30. The first three questions relate to anesthesia, and the next three relate to surgery. Of the three questions (related to anesthesia or surgery), two assess preoperative anxiety, and the third assesses the need for information.; The APAIS scale calculates four scores: overall anxiety, surgery-related anxiety, anesthesia-related anxiety, and information need. A total anxiety score of 11 or higher corresponds to a high level of anxiety.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	15 minutes after the end of surgery	Blood pressure measurement in both groups
Postoperative pain intensity	15 minutes after the End of surgery	Pain intensity will be assessed using a simple numerical rating scale (SNR) ranging from 0 (no pain) to 10 (worst imaginable pain).
Postoperative Overall Patient Satisfaction	15 minutes after the End of surgery	Overall Patient Satisfaction will be assessed using a simple numerical rating scale (SNR) ranging from 0 (not at all satisfied) to 10 (very satisfied).
Tolerance	15 minutes after the end of surgery	The tolerance of the test procedure will be assessed by collecting adverse events occurring during the duration of the study.
Intraoperative pain intensity	Immediately after surgery	Pain intensity will be assessed using a simple numerical rating scale (SNR) ranging from 0 (no pain) to 10 (worst imaginable pain).
Intraoperative comfort	15 minutes after the End surgery	Comfort will be assessed using a simple numerical rating scale (SNR) ranging from 0 (minimum comfort) to 10 (maximum comfort).
Change in salivary cortisol	15 minutes after the end of surgery	After rinsing the mouth with water, a 1 ml sample of salivary secretions without stimulation will be taken using a Salivette® (Sarstedt TM). The samples will be stored at -20°C before being analyzed by the private laboratory Eurofins, using an ELISA test (analytical sensitivity = 1.38 nmol/L; functional sensitivity = 8.28 nmol/L; upper detection limit \~110 nmol/L).
Heart rate	15 minutes after the end of surgery	Heart rate measurement in both groups

Trial Locations

Locations (1)

Clinique Monticelli; 🇫🇷 Marseille, France