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

NCT07050498 | Recruiting

• 1 other identifier: 2023-A01771-44
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractive Disorders

Keywords

refractive surgery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Intraoperative pain intensity

  Immediately after surgery

• Postoperative pain intensity

  15 minutes after the End of surgery

• Intraoperative comfort

  15 minutes after the End surgery

• Postoperative Overall Patient Satisfaction

  15 minutes after the End of surgery

• Change in salivary cortisol

  Before any study procedure

Study Arms (2)

Virtual reality

EXPERIMENTAL

Preoperative conditioning by virtual reality + Routine preoperative procedure (local anesthesia)

Device: Virtual reality

Usual care

ACTIVE COMPARATOR

Routine preoperative procedure (local anesthesia)

Procedure: Usual Care Group

Interventions

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.

Virtual reality

Usual Care Group PROCEDURE

Routine preoperative procedure (local anesthesia)

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique Monticelli

Marseille, 13008, France

RECRUITING

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, randomized, open-label study on two parallel groups of patients

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: July 3, 2025
• Study Start: September 18, 2024
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

FR (1)