NCT06230029

Music's Impact on Preoperative Anxiety: Heart Rate Variability Study During Cataract Surgery

Impact of Music on Preoperative Anxiety Level Measured by Heart Rate Variability During Cataract Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Randomized Controlled Trial is to evaluate heart rate variability (HRV)before and after listening to music in patients scheduled for cataract surgery under topical anesthesia, compared to patients who do not listen to music. Our hypothesis is that the anxious population with a low HRV benefits from an anxiolytic effect of music to increase HRV levels.

Conditions

• Anxiety
• Cataract Surgery
• Heart Rate Variability

Interventions

Type	Name	Description
OTHER	Music listening	Music will be played through individual headphones (BOSE AE2®). The headphones give the impression of personalized music that only the patient can hear. Patients will have a mask over their eyes to limit visual aggression. The songs will be pre-recorded on a digital tablet (Samsung Galaxy®) allowing the broadcasting of music programs. Patients will have the choice to listen to a song according to their musical preferences among 16 different musical styles. The volume will be adapted to the level that suits the patient.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-03-31
• Completion: 2024-03-31
• First posted: 2024-01-29
• Last updated: 2024-10-01

Locations

3 sites across 2 countries: France, Italy