Clinical trial NCT06953752: Effects of Music During Atrial Fibrillation Ablation Under Conscious Sedation
Official title: Effects of Music on Pain and Anxiety During Atrial Fibrillation Ablation Under Conscious Sedation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Catheter Ablation
Pain Management
Lead sponsor: Shaoxing People's Hospital
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.


Eligibility criteria: 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."

Primary outcomes:
measure: Wong-Baker FACES Pain Rating Scale Score
timeFrame: Immediately following the ablation procedure
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Preoperatively (baseline) and immediately postoperatively (upon procedure completion)
Secondary outcomes:
measure: Respiratory rate
timeFrame: During the procedure
measure: Respiratory interval variability
timeFrame: During the procedure
measure: Amplitude variability of respiratory waveform
timeFrame: During the procedure
measure: Apnea episodes
timeFrame: During the procedure
measure: Sample entropy of respiratory waveform
timeFrame: During the procedure
measure: Ablation time
timeFrame: During the procedure
measure: First-pass Left Pulmonary Vein Isolation (PVI) Rate
timeFrame: During the procedure
measure: First-pass Right Pulmonary Vein Isolation (PVI) Rate
timeFrame: During the procedure
measure: Analgesic Dosage
timeFrame: During the procedure
measure: Rescue analgesia events
timeFrame: During the procedure
Other outcomes:
measure: Total Procedure Time
timeFrame: During the procedure
measure: Total Fluoroscopy Duration
timeFrame: During the procedure
measure: Complications
timeFrame: One month following the ablation procedure.
measure: Patient and Operator Postprocedural Satisfaction Scores
timeFrame: Immediately following the ablation procedure
Locations:
Study officials:
References: