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Completed

NCT Number: NCT07766525

Complementary Music Therapy for Pain During Percutaneous Transluminal Angioplasty.

This study evaluated the effectiveness of complementary music therapy in reducing pain among hemodialysis patients undergoing percutaneous transluminal angioplasty (PTA) for arteriovenous fistula dysfunction. Participants were assigned to either a music intervention group or a control group. The intervention group listened to self-selected music during the procedure, while the control group received routine care without music. Pain intensity and physiological parameters, including heart rate, respiratory rate, and blood pressure, were assessed to determine the effects of complementary music therapy during PTA.

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Key information

Conditions

Arteriovenous Fistula Dysfunction Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taoyuan Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled to undergo percutaneous transluminal angioplasty (PTA) under local anesthesia.
  • Adults aged 18 years or older who are willing to participate and provide written informed consent.

Exclusion criteria

  • Patients with impaired consciousness or inability to express their pain perception.
  • Patients requiring additional anesthesia or sedation during the procedure due to their clinical condition.
  • Patients with hearing impairment or who use hearing aids.

Treatment and study plan

Complementary Music Therapy

Behavioral

Participants listened to self-selected music at 60-80 beats per minute through over-ear headphones from the beginning to the end of the PTA procedure, in addition to routine care.

Primary outcomes

  1. Pain Intensity Measured by the Visual Analog Scale (VAS)

    Time frame: During the PTA procedure, at up to five balloon inflation time points.

    Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, with higher scores indicating greater pain intensity. Pain was assessed during balloon inflation throughout the PTA procedure.

  2. Pain Intensity Measured by the Numeric Rating Scale (NRS)

    Time frame: Immediately after completion of the PTA procedure.

    Pain intensity was assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, with higher scores indicating greater pain intensity. After the PTA procedure, participants rated their current pain intensity and retrospectively rated the most and least pain experienced during the procedure.

Secondary outcomes

  1. Heart Rate During the PTA Procedure

    Time frame: Before, during, and immediately after the PTA procedure.

    Heart rate was measured in beats per minute (bpm) before, during, and after the PTA procedure. During the procedure, measurements were recorded at up to five balloon inflation time points.

  2. Respiratory Rate During the PTA Procedure

    Time frame: Before, during, and immediately after the PTA procedure.

    Respiratory rate was measured in breaths per minute before, during, and after the PTA procedure. During the procedure, measurements were recorded at up to five balloon inflation time points.

  3. Systolic Blood Pressure During the PTA Procedure

    Time frame: Before, during, and immediately after the PTA procedure.

    Systolic blood pressure was measured in mmHg before, during, and after the PTA procedure. During the procedure, measurements were recorded at up to five balloon inflation time points.

  4. Diastolic Blood Pressure During the PTA Procedure

    Time frame: Before, during, and immediately after the PTA procedure.

    Diastolic blood pressure was measured in mmHg before, during, and after the PTA procedure. During the procedure, measurements were recorded at up to five balloon inflation time points.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

The Effects of Complementary Music Therapy on Intraoperative Pain Reduction for Patients Undergoing Percutaneous Transluminal Angioplasty.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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