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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
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.
Routine preoperative procedure (local anesthesia)
Clinique Monticelli
Marseille, France
RECRUITINGPreoperative 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.
Time frame: Preoperative procedure
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).
Time frame: Immediately after surgery
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 15 minutes after the end of surgery
Heart rate
Heart rate measurement in both groups
Time frame: Before any study procedure
Blood pressure
Blood pressure measurement in both groups
Time frame: Before any study procedure
Heart rate
Heart rate measurement in both groups
Time frame: Before surgery
Blood pressure
Blood pressure measurement in both groups
Time frame: Before surgery
Heart rate
Heart rate measurement in both groups
Time frame: 15 minutes after the end of surgery
Blood pressure
Blood pressure measurement in both groups
Time frame: 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.
Time frame: 15 minutes after the end of surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.