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New treatment option for Refractive Disorders
Official title Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery
ClinicalTrials.gov ID: NCT07050498
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.