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临床试验/NCT07657923
NCT07657923已完成不适用

Effect of Music-Assisted Acupressure on Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients: A Randomized Controlled Trial

Gülsüm Gülşen1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年2月1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
72
试验地点
1
主要终点
Pain Intensity During AVF Cannulation (VAS Score)

研究概览

简要总结

This randomized controlled trial was conducted to evaluate the effect of music-assisted acupressure on pain experienced during arteriovenous fistula (AVF) cannulation in hemodialysis patients. The study was carried out with 72 patients receiving hemodialysis treatment three times per week via AVF in a state hospital in Gaziantep, Türkiye.

Participants were randomly assigned to one of four groups: music-assisted acupressure, acupressure alone, music alone, and control group (routine care). The acupressure intervention was applied to the Hegu (LI4) point for approximately 3 minutes prior to needle insertion, while the music intervention consisted of listening to instrumental Classical Turkish Music in the Acemaşiran mode through headphones starting 5 minutes before cannulation and continuing until the end of the procedure.

Pain intensity during AVF cannulation was measured using the Visual Analog Scale (VAS) during three consecutive dialysis sessions. The primary outcome was pain severity during needle insertion. The study aimed to determine whether combining music therapy and acupressure would provide greater pain relief compared to single interventions or routine care.

Findings suggest that music-assisted acupressure may be an effective non-pharmacological nursing intervention for reducing procedural pain in hemodialysis patients.

详细描述

This study was designed as a randomized controlled trial to investigate the effect of music-assisted acupressure on procedural pain during arteriovenous fistula (AVF) cannulation in patients undergoing hemodialysis. The study was conducted between March and November 2024 in the hemodialysis unit of a state hospital in Gaziantep, Türkiye.

A total of 72 eligible patients receiving hemodialysis treatment via AVF were included. Patients were randomly assigned into four equal groups (n=18 per group): music-assisted acupressure, acupressure, music, and control. Randomization was performed using a simple lottery method. All AVF cannulation procedures were performed by the same experienced dialysis nurse to ensure procedural consistency.

The acupressure intervention was applied to the Hegu (LI4) point on the hand contralateral to the AVF site. Finger pressure was applied perpendicularly for approximately 3 minutes prior to needle insertion. The music intervention consisted of listening to instrumental Classical Turkish Music in the Acemaşiran mode through headphones, beginning 5 minutes before cannulation and continuing until the end of the procedure.

Participants in the combined intervention group received both acupressure and music simultaneously using the same protocols described above. The control group received routine hemodialysis care without additional intervention.

Pain intensity during AVF cannulation was assessed using the Visual Analog Scale (VAS, 0-10) immediately after each procedure. Measurements were repeated over three consecutive hemodialysis sessions. Sociodemographic and clinical data were also collected using a structured patient information form.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

盲法说明

No blinding was applied in this study. Due to the nature of the interventions (music therapy and acupressure), participants, care providers, and investigators were not blinded. Outcome assessment was performed by the same researcher who collected the data; therefore, no additional masked parties were included.

入排标准

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

入选标准

  • •Age ≥ 18 years
  • •Receiving hemodialysis treatment three times per week
  • •Presence of an arteriovenous fistula (AVF) for vascular access
  • •Ability to communicate in Turkish
  • •No use of analgesic medication prior to AVF cannulation
  • •No pain or pathology in the upper extremities that could affect intervention application or pain assessment
  • •Willingness to participate in the study and provide informed consent

排除标准

  • •Diagnosis of neuropathy
  • •History of upper extremity surgery or soft tissue injury
  • •Presence of bleeding disorders or coagulation disorders
  • •Diagnosis of heart failure
  • •Presence of a pacemaker
  • •Inability to comply with study procedures or complete data collection
  • •Any condition that could interfere with pain perception or the application of acupressure or music intervention

研究组 & 干预措施

Standard Care

Other

Routine hemodialysis care without additional music or acupressure intervention during AVF cannulation.

干预措施: Standard Care (Other)

Music-Assisted Acupressure Group

Other

Listening to instrumental Classical Turkish Music (Acemaşiran mode) via headphones starting 5 minutes before AVF cannulation and continuing throughout the procedure.

干预措施: Music-Assisted Acupressure (Other)

Acupressure

Other

Manual acupressure applied to the Hegu (LI4) point on the hand contralateral to the AVF site for approximately 3 minutes prior to AVF cannulation.

干预措施: Acupressure (Other)

Music Group

Other

Participants listened to instrumental Classical Turkish Music in the Acemaşiran mode through headphones starting 5 minutes before AVF cannulation and continuing until the end of the procedure.

干预措施: Music Therapy (Other)

结局指标

主要结局

Pain Intensity During AVF Cannulation (VAS Score)

时间窗: During each hemodialysis session over 3 consecutive sessions (March-November 2024)

Pain intensity experienced during arteriovenous fistula (AVF) cannulation was assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Measurements were obtained immediately after each cannulation procedure across three consecutive hemodialysis sessions.

次要结局

  • Change in Pain Scores Over Time(Baseline and across 3 consecutive hemodialysis sessions)

研究者

发起方
Gülsüm Gülşen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gülsüm Gülşen

Specialist Nurse (PhD Candidate)

Gaziantep City Hospital

研究点 (1)

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