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

NCT07050498 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-07-03

No results posted yet for this study

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

Interventions

DEVICE

Virtual reality

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.

PROCEDURE

Usual Care Group

Routine preoperative procedure (local anesthesia)

Sponsors & Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-18
Primary Completion
2026-09-18
Completion
2026-09-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07050498 on ClinicalTrials.gov