Actively Recruiting
Effects of Music on Pain and Anxiety During Atrial Fibrillation Ablation Under Conscious Sedation: A Randomized Controlled Trial
Led by Shaoxing People's Hospital · Updated on 2025-07-10
120
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Atrial fibrillation is a common heart rhythm disorder often treated with radiofrequency catheter ablation, a minimally invasive procedure performed under light sedation. Many patients experience anxiety during this procedure due to pain, unfamiliar surroundings, and concerns about risks. This anxiety can increase pain sensitivity and affect breathing and surgical precision. Researchers are evaluating whether listening to music during the procedure can reduce anxiety and pain, stabilize breathing, and improve satisfaction and efficiency compared to no music. Participants are randomly assigned to either a music group or a control group. The music group selects preferred genres played at a moderate volume during the ablation, while the control group receives no music. The ablation is performed under conscious sedation with fentanyl and midazolam as needed. Patients with paroxysmal atrial fibrillation receive pulmonary vein isolation, and those with persistent atrial fibrillation may have additional heart wall ablation. The study includes 120 patients aged 18 to 80 undergoing their first catheter ablation. During the study, researchers collect patient information, health history, atrial fibrillation details, and test results. They measure pain using a face-based scale immediately after ablation and anxiety before and after the procedure with a questionnaire. They also monitor breathing stability, procedure duration, x-ray time, success rates, complications, drug use, patient and doctor satisfaction, and doctor fatigue. The trial follows a randomized controlled design to assess the impact of music on these outcomes.
CONDITIONS
Brief Title
Effects of Music During Atrial Fibrillation Ablation Under Conscious Sedation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing first-time catheter radiofrequency ablation for atrial fibrillation according to guidelines
- Aged 18 to 80 years
- Willing to participate and provide signed informed consent
You will not qualify if you...
- Active psychiatric conditions requiring medication
- Hearing loss or communication difficulties
- Candidates for general anesthesia
- Hybrid atrial fibrillation procedures (e.g., with LAA occlusion)
- Previous cardiac surgeries or catheter ablations
- Complex heart anatomies seen on imaging
- Recent (within 30 days) use of sedatives or pain medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of the ablation procedure
Participants undergo atrial fibrillation ablation under conscious sedation. Those in the music intervention group listen to preferred music genres during the procedure, while controls do not receive music.
1 visit (in-person, procedure day)
Duration - Immediately following the ablation procedure
Participants are assessed immediately after the procedure for pain and anxiety using standardized scales.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Shaoxing People's Hospital
Shaoxing, Zhejiang, China, 312000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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