Complementary Music Therapy for Pain During Percutaneous Transluminal Angioplasty.

NCT07766525 | Completed

• 1 other identifier: 202402308B0D0001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arteriovenous Fistula Dysfunction

Keywords

music therapy; percutaneous transluminal angioplasty; pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Heart Rate During the PTA Procedure

  Before, during, and immediately after the PTA procedure.

• Respiratory Rate During the PTA Procedure

  Before, during, and immediately after the PTA procedure.

• Systolic Blood Pressure During the PTA Procedure

  Before, during, and immediately after the PTA procedure.

• Diastolic Blood Pressure During the PTA Procedure

  Before, during, and immediately after the PTA procedure.

Study Arms (2)

Music Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants received routine care during the PTA procedure without complementary music therapy.

Interventions

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.

Music Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Taoyuan Chang Gung Memorial Hospital

Taoyuan, Taoyuan, 333, Taiwan

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: February 24, 2025
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)