Refractive Disorders
Conditions
Keywords
refractive surgery
Brief summary
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
DEVICEVirtual 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.
PROCEDUREUsual Care Group
Routine preoperative procedure (local anesthesia)
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-center, prospective, randomized, open-label study on two parallel groups of patients
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative anxiety level | Preoperative procedure | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity | 15 minutes after the End of surgery | Pain intensity will be assessed using a simple numerical rating scale (SNR) ranging from 0 (no pain) to 10 (worst imaginable pain). |
| Intraoperative comfort | 15 minutes after the End surgery | Comfort will be assessed using a simple numerical rating scale (SNR) ranging from 0 (minimum comfort) to 10 (maximum comfort). |
| Postoperative Overall Patient Satisfaction | 15 minutes after the End of surgery | Overall Patient Satisfaction will be assessed using a simple numerical rating scale (SNR) ranging from 0 (not at all satisfied) to 10 (very satisfied). |
| Intraoperative pain intensity | Immediately after surgery | Pain intensity will be assessed using a simple numerical rating scale (SNR) ranging from 0 (no pain) to 10 (worst imaginable pain). |
| Heart rate | Before any study procedure | Heart rate measurement in both groups |
| Blood pressure | Before any study procedure | Blood pressure measurement in both groups |
| Tolerance | 15 minutes after the end of surgery | The tolerance of the test procedure will be assessed by collecting adverse events occurring during the duration of the study. |
| Change in salivary cortisol | Before any study procedure | After rinsing the mouth with water, a 1 ml sample of salivary secretions without stimulation will be taken using a Salivette® (Sarstedt TM). The samples will be stored at -20°C before being analyzed by the private laboratory Eurofins, using an ELISA test (analytical sensitivity = 1.38 nmol/L; functional sensitivity = 8.28 nmol/L; upper detection limit \ 110 nmol/L). |
Countries
France
Outcome results
None listed