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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality | Experimental | Preoperative conditioning by virtual reality + Routine preoperative procedure (local anesthesia) |
|
| Usual care | Active Comparator | Routine preoperative procedure (local anesthesia) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preoperative procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Immediately after surgery |
| Postoperative pain intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Monticelli | Recruiting | Marseille | 13008 | France |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Single-center, prospective, randomized, open-label study on two parallel groups of patients
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| Usual Care Group | Procedure | Routine preoperative procedure (local anesthesia) |
|
Pain intensity will be assessed using a simple numerical rating scale (SNR) ranging from 0 (no pain) to 10 (worst imaginable pain).
| 15 minutes after the End of surgery |
| Intraoperative comfort | Comfort will be assessed using a simple numerical rating scale (SNR) ranging from 0 (minimum comfort) to 10 (maximum comfort). | 15 minutes after the End surgery |
| 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). | 15 minutes after the End of surgery |
| Change in salivary cortisol | 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). | Before any study procedure |
| Change in salivary cortisol | 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). | Just before surgery |
| Change in salivary cortisol | 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). | 15 minutes after the end of surgery |
| Heart rate | Heart rate measurement in both groups | Before any study procedure |
| Blood pressure | Blood pressure measurement in both groups | Before any study procedure |
| Heart rate | Heart rate measurement in both groups | Before surgery |
| Blood pressure | Blood pressure measurement in both groups | Before surgery |
| Heart rate | Heart rate measurement in both groups | 15 minutes after the end of surgery |
| Blood pressure | Blood pressure measurement in both groups | 15 minutes after the end of surgery |
| Tolerance | The tolerance of the test procedure will be assessed by collecting adverse events occurring during the duration of the study. | 15 minutes after the end of surgery |