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NCT Number: NCT07050498

Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery

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.

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Key information

Conditions

Refractive Disorders Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Monticelli

Marseille, 13008, France

Location status: Recruiting

Location contact

Louis HOFFART, MD

CONTACT

[email protected]

04 91 16 22 22 ext. 33

Louis HOFFART, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

usual care group

Procedure

Routine preoperative procedure (local anesthesia)

Primary outcomes

  1. Preoperative anxiety level

    Time frame: 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 outcomes

  1. Intraoperative pain intensity

    Time frame: 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).

  2. Postoperative pain intensity

    Time frame: 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).

  3. Intraoperative comfort

    Time frame: 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).

  4. Postoperative Overall Patient Satisfaction

    Time frame: 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).

  5. Change in salivary cortisol

    Time frame: 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).

  6. Change in salivary cortisol

    Time frame: Just before surgery

    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).

  7. Change in salivary cortisol

    Time frame: 15 minutes after the end of surgery

    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).

  8. Heart rate

    Time frame: Before any study procedure

    Heart rate measurement in both groups

  9. Blood pressure

    Time frame: Before any study procedure

    Blood pressure measurement in both groups

  10. Heart rate

    Time frame: Before surgery

    Heart rate measurement in both groups

  11. Blood pressure

    Time frame: Before surgery

    Blood pressure measurement in both groups

  12. Heart rate

    Time frame: 15 minutes after the end of surgery

    Heart rate measurement in both groups

  13. Blood pressure

    Time frame: 15 minutes after the end of surgery

    Blood pressure measurement in both groups

  14. Tolerance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: ERVAN

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 3, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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