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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230029
• Other study ID #: Musictop2
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
• Contact: Giuseppe Giannaccare
• Phone: 00393317186201
• Email: giuseppe.giannaccare[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Cataract
• Cataract Surgery
• Heart Rate Variability

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Cochin/Port-Royal	Paris
Italy	University of Cagliari	Cagliari
Italy	University of Catanzaro	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of heart rate variability before vs after listening to music in patients scheduled for cataract surgery under topical anesthesia.	Use of a non-invasive sensor: recording chest belt	Baseline vs pre-surgery
Secondary	Evaluation of the impact of music on the incidence of surgical complications	Incidence of posterior capsular rupture	Immediately after the surgery
Secondary	Measurement of subjective anxiety level	Surgical Fear Questionnaire (SFQ): The questionnaire consists of 8 questions (items). The Items 1-4 refer to the subscale 'fear of short term consequences of surgery', the items 5-8 refer to the subscale 'fear of long term consequences of surgery'. All items are scored on an eleven point numeric rating scale (NRS) ranging from 0 (not at all afraid) to 10 (very afraid). This results in a total score of 0 to 80, calculated by summing item 1-8.	Before surgery
Secondary	Measurement of subjective anxiety level	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: No Anxiety: The initial segment features a face showing calmness, symbolizing absence of anxiety.; Mild Anxiety: The second segment depicts a face with a slightly concerned expression, indicative of mild anxiety.; Moderate Anxiety: In the third segment, the face exhibits clear signs of worry, corresponding to moderate anxiety.; Severe Anxiety: The fourth segment portrays a face with a deeply troubled expression, denoting severe anxiety.; 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.	Before surgery