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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
Participants
Inclusion Criteria:
Exclusion Criteria:
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
Data Collected
Pain/Sedation Protocol
Ablation Procedure
Music Intervention
Outcomes Measured
Main Outcomes:
Secondary Outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music intervention | Experimental |
Music group patients select preferred genres (classical/pop/rock/jazz; classical default) delivered at 50-60 dB during the procedure. |
|
| Control | Other |
Controls receive no music. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music intervention | Other | Music group patients select preferred genres (classical/pop/rock/jazz; classical default) delivered at 50-60 dB during the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory rate | Mean peak-to-peak interval of respiratory waveform. Respiratory parameters are acquired through either:
| During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Total Procedure Time | During the procedure | |
| Total Fluoroscopy Duration | The cumulative duration of X-ray exposure (in minutes) from first to last fluoroscopic activation, as automatically recorded by the angiography system. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaoxing People's Hospital | Recruiting | Shaoxing | Zhejiang | 312000 | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Control | Other | Controls receive no music. |
|
| Respiratory interval variability | Standard deviation(respiratory interval)/Mean(respiratory interval)×100%. Respiratory parameters are acquired through either:
| During the procedure |
| Amplitude variability of respiratory waveform | Standard deviation (respiratory waveform amplitude)/Mean(respiratory waveform amplitude)×100%. Respiratory parameters are acquired through either:
| During the procedure |
| Apnea episodes | Defined as ≥10-second cessation of breathing. Respiratory parameters are acquired through either:
| During the procedure |
| Sample entropy of respiratory waveform | 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:
Sample entropy =-ln(A/B). | During the procedure |
| Ablation time | 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 | 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 | 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 | Total intraoperative analgesic consumption is quantified as: Fentanyl equivalents (mcg/kg): Sum of bolus and maintenance doses | During the procedure |
| Rescue analgesia events | Number of supplemental dose administrations of analgesic drug. | During the procedure |
| During the procedure |
| Complications | 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 | Satisfaction levels are assessed using a 5-point Likert scale (1=very dissatisfied, 5=very satisfied) | Immediately following the ablation procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |