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RECRUITING
NCT07050498
NA

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

Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2024-09-18

Completion Date

2026-09-18

Last Updated

2025-07-03

Healthy Volunteers

No

Interventions

DEVICE

Virtual reality

Virtual reality hypnosis software applications are Class I medical devices according to Rule 12 of Directive 93/42/EC. They allow, through a virtual reality headset and headphones, to immerse the patient in a hypnotic sound and visual environment. Several visual scenarios can be proposed, allowing the patient to virtually travel to a beach, the seabed, on an alpine walk, etc.). The HypnoVR Biofeedback virtual reality device is provided by the HypnoVR company.

PROCEDURE

Usual Care Group

Routine preoperative procedure (local anesthesia)

Locations (1)

Clinique Monticelli

Marseille, France