RecruitingNot ApplicableNCT07050498

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


Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrollment

68 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether virtual reality (VR) headsets can help reduce anxiety in patients waiting for laser eye surgery (refractive surgery). Researchers want to see if experiencing a calming VR environment before the procedure lowers stress and anxiety levels. **You may be eligible if:** - You are 18 or older - You are scheduled for refractive (laser) eye surgery - You have signed the consent form after an adequate reflection period **You may NOT be eligible if:** - You have uncontrolled epilepsy or significant hearing impairment (which can be worsened by VR) - You are pregnant or breastfeeding - You have certain hormonal disorders (Cushing's, Addison's, thyroid disease) - You are taking corticosteroids, antipsychotics, anti-anxiety medications, or antidepressants - You are not enrolled in the French social security system - You cannot understand the information or give written consent - You are already participating in another blinded research study Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVirtual 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.

PROCEDUREUsual Care Group

Routine preoperative procedure (local anesthesia)


Locations(1)

Clinique Monticelli

Marseille, France

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NCT07050498


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