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

January 28, 2024 updated by: Giuseppe Giannaccare, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Listening

The presentation of the music listening session will be standardized and will be as follows: "Make yourself comfortable; we will first choose the musical style; then adjust the volume; put on the headphones; then the mask; let us know if something is wrong; we can take off the headphones or the mask at any time if you wish; we will stay by your side".

The following data will be collected just before the headset is put on and just after its removal:

  • heart rate using a previously disinfected chest belt (PolarH10®)
  • blood pressure
  • level of anxiety (according to the validated SFQ and VAS scales)

Music listening session will last 15 minutes, at the end of which the headphones will be removed before the patient is transferred to the operating room.
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.
No Intervention: No Music

Heart rate variability monitoring while NOT listening to music. The presentation for the patients included in the group without music will be as follows: "Make yourself comfortable; we will first put on the headphones but there will be no music; let us know if anything is wrong; we can remove the headphones or mask at any time if you wish; we will stay by your side".

The following data will be collected just before the headset is put on and just after its removal:

  • heart rate using a previously disinfected chest belt (PolarH10®)
  • blood pressure
  • level of anxiety (according to the validated SFQ and VAS scales)

The session will last 15 minutes, at the end of which the headphones will be removed before the patient is transferred to the operating room.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the impact of music on the incidence of surgical complications
Time Frame: Immediately after the surgery
Incidence of posterior capsular rupture
Immediately after the surgery
Measurement of subjective anxiety level
Time Frame: Before surgery
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
Measurement of subjective anxiety level
Time Frame: 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.
Before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 21, 2024

First Posted (Actual)

January 29, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Musictop2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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