NCT07050498

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Refractive Disorders

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-09-18
• Primary completion: 2026-09-18
• Completion: 2026-09-18
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: France