Complementary Music Therapy for Pain During Percutaneous Transluminal Angioplasty.

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

Study Overview

• Status: Completed
• Conditions: Arteriovenous Fistula Dysfunction
• Intervention / Treatment: Behavioral: Complementary Music Therapy

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan
    • Taoyuan, Taoyuan, Taiwan, 333
      • Taoyuan Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complementary Music Therapy Group; Participants received complementary music therapy during the PTA procedure in addition to routine care. Participants listened to self-selected music at 60-80 beats per minute through over-ear headphones from the beginning to the end of the procedure.	Behavioral: Complementary Music Therapy; 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.
No Intervention: Routine Care Group; Participants received routine care during the PTA procedure without complementary music therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity Measured by the Visual Analog Scale (VAS)	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.	During the PTA procedure, at up to five balloon inflation time points.
Pain Intensity Measured by the Numeric Rating Scale (NRS)	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.	Immediately after completion of the PTA procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate During 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.	Before, during, and immediately after the PTA procedure.
Respiratory Rate During 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.	Before, during, and immediately after the PTA procedure.
Systolic Blood Pressure During 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.	Before, during, and immediately after the PTA procedure.
Diastolic Blood Pressure During 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.	Before, during, and immediately after the PTA procedure.

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Actual): November 24, 2025
• Study Completion (Actual): November 24, 2025

Study Registration Dates

• First Submitted: August 11, 2026
• First Submitted That Met QC Criteria: August 11, 2026
• First Posted (Actual): August 14, 2026

Study Record Updates

• Last Update Posted (Actual): August 20, 2026
• Last Update Submitted That Met QC Criteria: August 18, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: pain; music therapy; percutaneous transluminal angioplasty
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 202402308B0D0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to participant privacy and confidentiality considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No