Effects of Music During Atrial Fibrillation Ablation Under Conscious Sedation

NCT06953752 | Recruiting DMC

• 1 other identifier: IEC-K-AF-016-1.3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

• 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).
• Sample Size 60 patients/group (120 total) will be chosen.
• Blinding
• Patients and doctors know the group assignment (music or no music).
• Researchers assessing pain/anxiety and statisticians are blinded.
• 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).
• Pain/Sedation Protocol
• Light sedation with fentanyl (adjusted as needed).
• Extra midazolam given if heart rhythm needs electric correction.
• 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.
• Music Intervention
• Music Group: Patients pick preferred music (classical, pop, etc.) played at 50-60 dB during procedure.
• Control Group:\*No music.
• Outcomes Measured
• 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.

Conditions

Atrial Fibrillation (AF); Catheter Ablation; Pain Management

Outcome Measures

Primary Outcomes (2)

• Wong-Baker FACES Pain Rating Scale Score

  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)

  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 Outcomes (10)

• Respiratory rate

  During the procedure

• Respiratory interval variability

  During the procedure

• Amplitude variability of respiratory waveform

  During the procedure

• Apnea episodes

  During the procedure

• Sample entropy of respiratory waveform

  During the procedure

Other Outcomes (4)

• Total Procedure Time

  During the procedure

• Total Fluoroscopy Duration

  During the procedure

• Complications

  One month following the ablation procedure.

Study Arms (2)

Music intervention

EXPERIMENTAL

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

Control

OTHER

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

Interventions

Music intervention OTHER

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

Music intervention

Control OTHER

Controls receive no music.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shaoxing People's Hospital: lead

Study Sites (1)

Shaoxing People's Hospital

Shaoxing, Zhejiang, 312000, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Agnosia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 1, 2025
• Study Start: July 6, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 10, 2025

Record last verified: 2025-04

Locations

CN (1)