Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery
Recruiting · NCT07050498 · Interventional (participants receive a specific treatment) · Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
View the official record on ClinicalTrials.gov →Interventions studied
Usual Care GroupVirtual reality
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Clinique Monticelli - Marseille, France