Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07050498

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

Led by GCS Ramsay Santé pour l'Enseignement et la Recherche · Updated on 2025-07-03

68

Participants Needed

1

Research Sites

104 weeks

Total Duration

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AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinique Monticelli

Marseille, France, 13008

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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