Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery
NCT ID: NCT07050498
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
68 participants
INTERVENTIONAL
2024-09-18
2026-09-18
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Virtual reality
Preoperative conditioning by virtual reality + Routine preoperative procedure (local anesthesia)
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.
Usual care
Routine preoperative procedure (local anesthesia)
Usual Care Group
Routine preoperative procedure (local anesthesia)
Interventions
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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.
Usual Care Group
Routine preoperative procedure (local anesthesia)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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GCS Ramsay Santé pour l'Enseignement et la Recherche
OTHER
Responsible Party
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Locations
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Clinique Monticelli
Marseille, , France
Countries
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Facility Contacts
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Other Identifiers
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2023-A01771-44
Identifier Type: -
Identifier Source: org_study_id
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