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

Not Applicable

Completed

• Conditions: Anxiety; Heart Rate Variability; Cataract Surgery

• Registration Number: NCT06230029
• Lead Sponsor: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-01-21
• Study First Posted: 2024-01-29
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-28
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• information and consent of the patient,
• age greater than or equal to 18 years,
• affiliation to a social security system,
• benefiting from non-emergency ambulatory cataract surgery under topical anesthesia
• not being under legal protection.

Exclusion Criteria

• Refusal to participate,
• language barriers that are incompatible with a reliable assessment
• use of beta-blockers, including eye drops
• use of adrenergic, antiadrenergic, cholinergic and anticholinergic drugs
• use of psychotropic drugs, anxiolytics.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of heart rate variability before vs after listening to music in patients scheduled for cataract surgery under topical anesthesia.	Baseline vs pre-surgery	Use of a non-invasive sensor: recording chest belt

Secondary Outcome Measures

Name	Time	Method
Measurement of subjective anxiety level	Before surgery	Visual Analogue scale (VAS).; In this 5-score system, we employ illustrative facial expressions to represent varying degrees of anxiety. Each segment is paired with a distinct face, visually conveying the corresponding level of anxiety: 1. No Anxiety: The initial segment features a face showing calmness, symbolizing absence of anxiety.; 2. Mild Anxiety: The second segment depicts a face with a slightly concerned expression, indicative of mild anxiety.; 3. Moderate Anxiety: In the third segment, the face exhibits clear signs of worry, corresponding to moderate anxiety.; 4. Severe Anxiety: The fourth segment portrays a face with a deeply troubled expression, denoting severe anxiety.; 5. Extreme Anxiety: The final segment illustrates a face overwhelmed with distress, representing extreme or unbearable anxiety.; Patients are invited to select the face that best aligns with their current perceived level of anxiety, enabling a more relatable and empathetic approach to self-assessment.
Evaluation of the impact of music on the incidence of surgical complications	Immediately after the surgery	Incidence of posterior capsular rupture

Trial Locations

Locations (3)

Eye Clinic, Department of Surgical Sciences, University of Cagliari; 🇮🇹 Cagliari, Italy

Hôpital Cochin/Port-Royal; 🇫🇷 Paris, France

University of Catanzaro; 🇮🇹 Catanzaro, Italy