Effects of Music During Atrial Fibrillation Ablation Under Conscious Sedation

July 6, 2025 updated by: Buyun Xu, Shaoxing People's Hospital

Effects of Music on Pain and Anxiety During Atrial Fibrillation Ablation Under Conscious Sedation: A Randomized Controlled Trial

I. Background Atrial fibrillation, a common type of arrhythmia, is often treated with radiofrequency catheter ablation, a minimally invasive procedure that helps restore a normal heart rhythm. While this surgery is typically performed under "light sedation" (where patients remain semi-awake) and allows for quick recovery, many patients still experience significant anxiety during the procedure due to pain, unfamiliar surroundings, or concerns about surgical risks. Research shows that anxiety not only makes people more sensitive to pain but can also trigger physical tension, irregular breathing, and even affect the precision of the surgeon's movements-potentially prolonging the procedure or increasing the risk of complications.

Currently, hospitals primarily rely on sedatives and painkillers to ease patient discomfort. However, these medications may cause side effects like low blood pressure or slowed breathing, which can be particularly dangerous for older patients with heart conditions. As a safer alternative, non-drug approaches like music therapy are gaining attention. Studies suggest that listening to music can reduce anxiety and pain in other medical settings (such as during biopsies or pre-surgery preparation), likely because it helps the body relax, reduces stress hormones, or distracts the mind. Yet, there's limited evidence on whether music can provide similar benefits during atrial fibrillation catheter ablation, especially in helping patients maintain steady breathing.

To address this gap, the present study aims to explore how music interventions affect anxiety, pain, and breathing stability in patients undergoing atrial fibrillation catheter ablation. Investigators hope this research will offer practical solutions to improve patient comfort, reduce reliance on medications, and enhance surgical safety, while also providing scientific support for expanding non-drug therapies in cardiac procedures.

II. Study Purpose To evaluate whether music during atrial fibrillation catheter ablation helps reduce patients' anxiety and pain, stabilize breathing, and improve satisfaction for both patients and doctors while making the procedure more efficient.

III. Study Design Prospective randomized controlled trial

IV. Study Plan

  1. Participants

    Inclusion Criteria:

    • First-time atrial fibrillation ablation patients (aged 18-80) following clinical guidelines.
    • Willing to participate and sign consent.

    Exclusion Criteria:

    • Mental health issues (e.g., anxiety requiring medication, sleep disorders).
    • Hearing loss, communication difficulties, or need for general anesthesia.
    • Prior heart surgeries or catheter ablation, complex heart anatomy, or recent pain/sedation medication use.

    Grouping: Patients split evenly into "music group" or "control group," based on atrial fibrillation type (persistent or paroxysmal).

  2. Sample Size 60 patients/group (120 total) will be chosen.

  3. Blinding

    • Patients and doctors know the group assignment (music or no music).
    • Researchers assessing pain/anxiety and statisticians are blinded.

  4. Data Collected

    • Basic info (age, weight, education).
    • Health history (smoking, heart conditions, medications).
    • Atrial fibrillation details (type, duration).
    • Test results (e.g., heart size, kidney function).

  5. Pain/Sedation Protocol

    • Light sedation with fentanyl (adjusted as needed).
    • Extra midazolam given if heart rhythm needs electric correction.

  6. Ablation Procedure

    • For Paroxysmal atrial fibrillation: Isolate lung veins.
    • For Persistent atrial fibrillation: Extra ablation lines on heart walls.
    • Power and pressure settings vary by heart area to balance safety and effectiveness.

  7. Music Intervention

    • Music Group: Patients pick preferred music (classical, pop, etc.) played at 50-60 dB during procedure.
    • Control Group:*No music.
  8. Outcomes Measured

Main Outcomes:

  • Pain: Rated by patients post-surgery using a face-based scale.
  • Anxiety: Measured before and after surgery with a standard questionnaire.

Secondary Outcomes:

  • Breathing Stability: Breathing rate, pauses, and patterns.
  • Procedure Efficiency: Surgery duration, X-ray time, success rate.
  • Complications: Bleeding, heart injury, stroke risk.
  • Drug Use: Amount of painkillers needed.
  • Satisfaction: Ratings from patients and doctors (1-5 scale).
  • Doctor Fatigue: Self-reported by surgeons.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • China
    • Zhejiang
      • Shaoxing, Zhejiang, China, 312000
        • Recruiting
        • Shaoxing People's Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients undergoing first-time catheter radiofrequency ablation for atrial fibrillation at our center according to guideline recommendations;
  2. Aged 18-80 years;
  3. Willing to participate in the study and providing signed informed consent.

Exclusion Criteria:

  1. Active psychiatric conditions necessitating pharmacotherapy;
  2. Auditory/cognitive barriers to protocol compliance;
  3. General anesthesia candidates;
  4. Hybrid AF procedures (e.g., concomitant LAA occlusion);
  5. Previous cardiac interventions;
  6. Complex anatomies per preprocedural imaging (e.g., persistent left superior vena cava, cor triatriatum);
  7. Recent (≤30 days) sedative/analgesic exposure."

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Music intervention

  1. Intraoperative Analgesia and Sedation Protocol:

    The procedure is performed under conscious sedation using fentanyl (1 ug/kg loading dose post-transseptal puncture, then 1-2 ug/kg/h maintenance infusion titrated in 0.25 ug/kg/h increments). Midazolam 3-5 mg is administered for cardioversion with flumazenil reversal.

  2. Ablation Protocol:

    Ablation is performed using EnSite/CARTO systems. Paroxysmal AF patients receive bilateral pulmonary vein isolation ± trigger ablation; persistent AF patients receive additional posterior wall box ablation. Endpoints include bidirectional PVI (20-min observation) and roof line block. Posterior wall ablation is optional due to esophageal risk.

  3. Music Intervention:

Music group patients select preferred genres (classical/pop/rock/jazz; classical default) delivered at 50-60 dB during the procedure.
Other: Music intervention
Music group patients select preferred genres (classical/pop/rock/jazz; classical default) delivered at 50-60 dB during the procedure.
Other: Control

  1. Intraoperative Analgesia and Sedation Protocol:

    The procedure is performed under conscious sedation using fentanyl (1 ug/kg loading dose post-transseptal puncture, then 1-2 ug/kg/h maintenance infusion titrated in 0.25 ug/kg/h increments). Midazolam 3-5 mg is administered for cardioversion with flumazenil reversal.

  2. Ablation Protocol:

    Ablation is performed using EnSite/CARTO systems. Paroxysmal AF patients receive bilateral pulmonary vein isolation ± trigger ablation; persistent AF patients receive additional posterior wall box ablation. Endpoints include bidirectional PVI (20-min observation) and roof line block. Posterior wall ablation is optional due to esophageal risk.

  3. Music Intervention:

Controls receive no music.
Other: Control
Controls receive no music.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wong-Baker FACES Pain Rating Scale Score
Time Frame: Immediately following the ablation procedure
Postoperative pain assessment is performed immediately following the ablation procedure using the modified Wong-Baker FACES Pain Rating Scale (scored 0-10, where higher scores indicate greater pain intensity), with patients instructed to select the facial expression corresponding to their peak intraoperative pain experience.
Immediately following the ablation procedure
State-Trait Anxiety Inventory (STAI)
Time Frame: Preoperatively (baseline) and immediately postoperatively (upon procedure completion)
Anxiety levels are assessed using a shortened version of the original 20-item State-Trait Anxiety Inventory (the STAI-6, including three anxiety-present and anxiety-absent items, and each rated on a 4-point scale) at two time points: preoperatively (baseline) and immediately postoperatively (upon procedure completion).
Preoperatively (baseline) and immediately postoperatively (upon procedure completion)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Respiratory rate
Time Frame: During the procedure

Mean peak-to-peak interval of respiratory waveform.

Respiratory parameters are acquired through either:

  1. Built-in respiratory waveform of the 3D electroanatomical mapping system (e.g., EnSite™ or CARTO™), or
  2. Dedicated commercial respiratory monitoring devices (e.g., BioSignalPlux SOMNOtouch™ RESP), with signals synchronized to ablation timestamps.
During the procedure
Respiratory interval variability
Time Frame: During the procedure

Standard deviation(respiratory interval)/Mean(respiratory interval)×100%.

Respiratory parameters are acquired through either:

  1. Built-in respiratory waveform of the 3D electroanatomical mapping system (e.g., EnSite™ or CARTO™), or
  2. Dedicated commercial respiratory monitoring devices (e.g., BioSignalPlux SOMNOtouch™ RESP), with signals synchronized to ablation timestamps.
During the procedure
Amplitude variability of respiratory waveform
Time Frame: During the procedure

Standard deviation (respiratory waveform amplitude)/Mean(respiratory waveform amplitude)×100%.

Respiratory parameters are acquired through either:

  1. Built-in respiratory waveform of the 3D electroanatomical mapping system (e.g., EnSite™ or CARTO™), or
  2. Dedicated commercial respiratory monitoring devices (e.g., BioSignalPlux SOMNOtouch™ RESP), with signals synchronized to ablation timestamps.
During the procedure
Apnea episodes
Time Frame: During the procedure

Defined as ≥10-second cessation of breathing.

Respiratory parameters are acquired through either:

  1. Built-in respiratory waveform of the 3D electroanatomical mapping system (e.g., EnSite™ or CARTO™), or
  2. Dedicated commercial respiratory monitoring devices (e.g., BioSignalPlux SOMNOtouch™ RESP), with signals synchronized to ablation timestamps.
During the procedure
Sample entropy of respiratory waveform
Time Frame: During the procedure

Definition: A measure of respiratory signal complexity where: Lower values (0-1) indicate regular breathing patterns; Higher values (>1.5) reflect irregularity (e.g., pain-induced variability).

Calculation Steps:

  • Preprocess Signal

    1. Sample respiratory waveform at ≥100 Hz;
    2. Bandpass filter (0.1-1 Hz) to remove artifacts;
    3. Normalize to SD=1.

  • Set Parameters:

    1. Embedding dimension (*m*)=2 (standard for physiologic signals);
    2. Tolerance (*r*)=0.2×SD (typically 0.1-0.25);
    3. Time series length (N)=200-500 breaths.

  • Algorithm:

    1. Construct template vectors: Xm(i)=[u(i),u(i+1),...,u(i+m-1)];

    2. Count vector pairs where Chebyshev distance ≤ *r*:

      B = matches for *m*-point vectors A = matches for (*m*+1)-point vectors;

    3. Compute:

Sample entropy =-ln(A/B).
During the procedure
Ablation time
Time Frame: During the procedure
Ablation time represents the sum of all radiofrequency application durations throughout the procedure, recorded in minutes
During the procedure
First-pass Left Pulmonary Vein Isolation (PVI) Rate
Time Frame: During the procedure
Defined as the proportion of left pulmonary veins achieving complete electrical isolation after initial circumferential ablation without touch-up lesions.
During the procedure
First-pass Right Pulmonary Vein Isolation (PVI) Rate
Time Frame: During the procedure
Defined as the proportion of Right pulmonary veins achieving complete electrical isolation after initial circumferential ablation without touch-up lesions.
During the procedure
Analgesic Dosage
Time Frame: During the procedure
Total intraoperative analgesic consumption is quantified as: Fentanyl equivalents (mcg/kg): Sum of bolus and maintenance doses
During the procedure
Rescue analgesia events
Time Frame: During the procedure
Number of supplemental dose administrations of analgesic drug.
During the procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Procedure Time
Time Frame: During the procedure
During the procedure
Total Fluoroscopy Duration
Time Frame: During the procedure
The cumulative duration of X-ray exposure (in minutes) from first to last fluoroscopic activation, as automatically recorded by the angiography system.
During the procedure
Complications
Time Frame: One month following the ablation procedure.
Procedure-related adverse events are classified according to the 2023 HRS/EHRA/APHRS consensus statement:
One month following the ablation procedure.
Patient and Operator Postprocedural Satisfaction Scores
Time Frame: Immediately following the ablation procedure
Satisfaction levels are assessed using a 5-point Likert scale (1=very dissatisfied, 5=very satisfied)
Immediately following the ablation procedure

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shaoxing People's Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IEC-K-AF-016-1.3

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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