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临床试验/NCT07766525
NCT07766525已完成不适用

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

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年2月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
试验地点
1
主要终点
Pain Intensity Measured by the Visual Analog Scale (VAS)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Complementary Music Therapy 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.

干预措施: Complementary Music Therapy (Behavioral)

Routine Care Group

No Intervention

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

结局指标

主要结局

Pain Intensity Measured by the Visual Analog Scale (VAS)

时间窗: 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.

Pain Intensity Measured by the Numeric Rating Scale (NRS)

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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