An interventional study of Virtual reality and Usual Care Group in Refractive Disorders, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Treatment
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.
420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.
This study's planned enrollment of 68 is below the median of 76 across 301 interventional studies indexed under Refractive Errors.
Browse Refractive Errors studies →GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 207 studies on the registry; 99 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preoperative conditioning by virtual reality + Routine preoperative procedure (local anesthesia)
Device: Virtual reality
Routine preoperative procedure (local anesthesia)
Procedure: Usual Care Group
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)
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.
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
Plan to share: Undecided
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