About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Virtual reality
DeviceVirtual 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.
Usual Care Group
Procedure/SurgeryRoutine preoperative procedure (local anesthesia)
Treatment groups
Trial outcomes
Primary outcomes
Preoperative anxiety level
The preoperative anxiety level is measured on the APAIS scale. The APAIS scale is a self-assessment consisting of six questions with expected responses rated from 1 (the patient strongly disagrees with the statement) to 5 (the patient strongly agrees with the statement) out of a minimum overall score of 6 and a maximum overall score of 30. The first three questions relate to anesthesia, and the next three relate to surgery. Of the three questions (related to anesthesia or surgery), two assess preoperative anxiety, and the third assesses the need for information. The APAIS scale calculates four scores: overall anxiety, surgery-related anxiety, anesthesia-related anxiety, and information need. A total anxiety score of 11 or higher corresponds to a high level of anxiety.
Secondary outcomes
Intraoperative pain intensity
Pain intensity will be assessed using a simple numerical rating scale (SNR) ranging from 0 (no pain) to 10 (worst imaginable pain).
Postoperative pain intensity
Pain intensity will be assessed using a simple numerical rating scale (SNR) ranging from 0 (no pain) to 10 (worst imaginable pain).
Intraoperative comfort
Comfort will be assessed using a simple numerical rating scale (SNR) ranging from 0 (minimum comfort) to 10 (maximum comfort).
Postoperative Overall Patient Satisfaction
Overall Patient Satisfaction will be assessed using a simple numerical rating scale (SNR) ranging from 0 (not at all satisfied) to 10 (very satisfied).
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