Shaoxing People's Hospital

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a widely used procedure for diagnosing and treating pancreatic and biliary diseases. Despite its benefits, ERCP carries a risk of post-procedure pancreatitis (PEP), which occurs in approximately 12.2% of cases and can significantly increase healthcare costs and patient morbidity. Preventing PEP is crucial for improving patient outcomes and reducing the economic burden of ERCP.
Nonsteroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, have been shown to be effective in reducing the incidence of PEP when administered rectally before ERCP. The standard dose recommended by guidelines is 100mg, which has been associated with a significant reduction in PEP rates. However, higher doses of NSAIDs can increase the risk of adverse events, including gastrointestinal bleeding and renal impairment. Therefore, there is a need to determine whether a lower dose can provide similar benefits without increasing these risks.
This multicenter, non-inferiority, double-blind, randomized controlled trial will be conducted in China. Participants will be adults aged 18 or older scheduled for ERCP. They will be randomly assigned in a 1:1 ratio to either the low-dose (50mg) or standard-dose (100mg) indomethacin group. The intervention will be administered rectally 30 minutes before the ERCP procedure. The study will follow a double-blind design, ensuring that both patients and investigators are unaware of the treatment allocation.
The results of this trial could significantly influence clinical practice by providing evidence on the effectiveness of a lower dose of indomethacin in preventing PEP. This could lead to a reduction in the risk of adverse events associated with higher doses and potentially decrease healthcare costs without compromising patient safety. By optimizing the dosing of indomethacin, this study aims to improve the safety and cost-effectiveness of ERCP procedures.

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.

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