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Recruiting NCT07050498

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

No phase Interventional Refractive Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality, Usual Care Group.
Who it may be relevant to
Registry conditions: Refractive Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

This is a prospective, randomized, open-label, single-center study conducted on two parallel groups of patients undergoing refractive surgery (virtual reality preoperative conditioning or routine preoperative procedure). Therapeutic benefit is based on the assessment of preoperative anxiety using the APAIS scale.

Interventions

  • Device 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.
  • Procedure Usual Care Group
    Routine preoperative procedure (local anesthesia)

Primary outcome measures

  • Preoperative anxiety level [Time frame: Preoperative procedure]
Secondary outcome measures (12)
  • Intraoperative pain intensity [Time frame: Immediately after surgery]
  • Postoperative pain intensity [Time frame: 15 minutes after the End of surgery]
  • Intraoperative comfort [Time frame: 15 minutes after the End surgery]
  • Postoperative Overall Patient Satisfaction [Time frame: 15 minutes after the End of surgery]
  • Change in salivary cortisol [Time frame: Before any study procedure]
  • Change in salivary cortisol [Time frame: Just before surgery]
  • Change in salivary cortisol [Time frame: 15 minutes after the end of surgery]
  • Heart rate [Time frame: Before any study procedure]
  • Blood pressure [Time frame: Before any study procedure]
  • Heart rate [Time frame: Before surgery]
  • Blood pressure [Time frame: Before surgery]
  • Heart rate [Time frame: 15 minutes after the end of surgery]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Clinique Monticelli — Marseille

Identifiers

NCT: NCT07050498 · 2023-A01771-44

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗