Virtual-reality relaxation before refractive eye surgery to reduce preoperative anxiety
Official title: Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery
Run by GCS Ramsay Santé pour l'Enseignement et la Recherche · NCT07050498 · Data updated 2026-11-12
This study will test whether a short multisensory virtual-reality relaxation session before refractive surgery can lower anxiety and stress in adults having vision-correcting procedures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 68 (estimated) |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Marseille) |
| Status | Recruiting |
| Started | September 18, 2024 |
| Main results expected | September 18, 2026 |
| Study ends | September 18, 2026 |
| Registry record updated | July 3, 2025 |
| Trial ID | NCT07050498 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) scheduled for refractive surgery who can read French, give informed consent, and are not taking corticosteroids or psychotropic medications are ideal candidates.
✕Probably not a fit
Patients with contraindications to virtual reality (for example uncontrolled epilepsy or significant hearing impairment), those who are pregnant or breastfeeding, on anxiolytics/antidepressants or corticosteroids, or with certain endocrine disorders are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, randomized, open-label, single-center trial comparing a virtual-reality multisensory immersion session given before refractive surgery to the usual preoperative routine in two parallel groups. Preoperative anxiety will be measured using the APAIS psychometric scale and salivary cortisol as a physiological stress marker. Eligible adults must be able to give informed consent and must not have contraindications to virtual reality or be on certain psychiatric or corticosteroid medications. The study is conducted at Clinique Monticelli in Marseille, France.
Why it matters
Potential benefit: If successful, the virtual-reality session could reduce patients' preoperative anxiety and physiological stress, making the surgical experience more comfortable.
How similar studies have gone: Virtual reality has shown anxiety-reducing effects in other preoperative and procedural settings, although evidence specifically in refractive eye surgery is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Clinique Monticelli
Marseille, France Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.