The Effect of Different Types of Music on Pain and Anxiety During Wound Care Procedures in Patients With Venous Ulcers: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 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
Objective: To evaluate the effects of different types of music (instrumental Turkish music and Western music without lyrics) played during wound care on pain, anxiety, and patient satisfaction among individuals with venous ulcers.
Methods: In this randomized controlled trial, 97 patients with venous ulcers were assigned to three groups: Western Music (n=32), Turkish Music (n=32), and Control (n=33). Patients in the music groups listened to their assigned music during routine wound dressing, while all patients received individualized, evidence-based care. Pain and anxiety were measured with VAS and STAI before, during, and after dressing, and patient satisfaction was assessed with VAS post-procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients attending the outpatient clinic with venous leg ulcers (CEAP classification: C6 - active ulcers)
- •Age between 18 and 65 years
- •Absence of neuropathy
- •Willingness to listen to music and voluntary participation
- •Literacy (able to read and write)
- •No visual or hearing impairments
- •No cognitive deficits; fully oriented to time, place, and person
- •Turkish-speaking
- •No formal music education
排除标准
- •Diagnosis of diabetes or diabetic foot
- •Use of analgesic medications prior to or during routine wound care
- •Individuals younger than 18 or older than 65 years
- •Patients with psychiatric disorders
- •Individuals with intellectual disabilities
- •Patients with severe anxiety levels (STAI-S score 60-79 indicating severe anxiety)
结局指标
主要结局
Pain intensity measured by the Visual Analog Scale (VAS)
时间窗: Immediately before wound dressing; Periprocedural period; Immediately after wound dressing
Pain intensity will be assessed using a 0-10 cm Visual Analog Scale (VAS), where higher scores indicate more severe pain.
State anxiety level measured by the State Anxiety Inventory (STAI-S) score
时间窗: Before the wound dressing procedure; Immediately after the wound dressing procedure
State anxiety will be assessed using the State Anxiety Inventory (STAI-S), a 20-item validated self-report scale that measures situational (state) anxiety. Scores range from 20 to 80, with higher scores indicating greater anxiety levels.
次要结局
未报告次要终点
研究者
Gülay OYUR ÇELİK
Asst. Prof. Dr.
Izmir Katip Celebi University