Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06953752

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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