Mirror Therapy Versus Music Therapy for Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients: 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
- 75
- 试验地点
- 1
- 主要终点
- Procedural pain intensity during arteriovenous fistula cannulation
研究概览
简要总结
Inserting needles into the vascular access (fistula) is a major source of pain and anxiety for many hemodialysis patients. This study compared two simple, non-drug techniques to reduce this pain: listening to music and looking into a mirror during the needle insertion.
A total of 75 adult patients receiving regular hemodialysis at Izmir Özel Can Dialysis Center were randomly divided into three groups: a music group, a mirror group, and a control group. Patients in the music group listened to calming, instrumental Turkish classical music (makam) via headphones during cannulation. Patients in the mirror group looked at the reflection of their healthy arm in a mirror. The control group received standard care without these interventions.
Pain intensity was measured immediately after needle insertion using a 10-cm Visual Analogue Scale (VAS), where 0 means "no pain" and 10 means "the worst imaginable pain." Pain scores were compared between the groups to determine which method was more effective.
The results of this study may provide nurses and patients with easy-to-use, evidence-based options to make hemodialysis needle procedures less painful and stressful.
详细描述
Study Design: This was a prospective, three-arm, parallel-group, randomized controlled trial with a 1:1:1 allocation ratio.
Setting and Sample: The study was conducted at the Hemodialysis Unit of Izmir Özel Can Dialysis Center between December 1 and 30, 2025. The study population consisted of 150 patients. The sample size was calculated using G*Power 3.1.9.2 software. With a significance level (alpha) of 0.05, a power (1-beta) of 80%, and an effect size of 5%, a sample of 25 patients per group (total n=75) was determined to be sufficient for a three-group comparison.
Inclusion Criteria:
Age between 18 and 85 years.
Receiving hemodialysis treatment three times per week.
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
- None
盲法说明
Due to the nature of the interventions (music listening and mirror viewing), participants and the nurses providing care were not blinded to group assignment. However, the statistician who performed the final data analysis was blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 18-85 years of age or older
- •Receiving HD treatment 3 days a week
- •Being able to read and write
- •Having no hearing impairment
- •Having Turkish as their native language
- •Having received HD treatment for at least 6 months
- •Having a VAS pain score >3
- •Agreeing to listen to music
排除标准
- •Having a psychological disorder
- •Having communication problems
- •Having cancer
- •Not wanting to participate in the study
研究组 & 干预措施
Mirror group
During arteriovenous fistula cannulation, patients viewed the reflection of their healthy arm in a 40-cm mirror placed approximately 30 cm away. They focused on this image for 10 minutes before cannulation (adaptation phase), and the procedure was performed while they continued to look at the mirror. The visual illusion aimed to modulate pain perception.
干预措施: Mirror Therapy (Visual Illusion Therapy) (Device)
Music group
During arteriovenous fistula cannulation, patients listened to pre-selected, calming instrumental Turkish classical music (Nihavend and Muhayyerkürdi maqams) via headphones and an MP3 player at a comfortable volume. The music started before cannulation and continued throughout the procedure.
干预措施: Music Therapy (Other)
Control group
Patients received routine, standard cannulation care as per the hemodialysis unit protocol, without any additional non-pharmacological intervention such as mirror or music therapy.
结局指标
主要结局
Procedural pain intensity during arteriovenous fistula cannulation
时间窗: Procedure (during cannulation)
Pain intensity experienced by the patient immediately following the needle insertion for hemodialysis. This primary outcome is measured during the second and third hemodialysis sessions following randomization (the first session post-randomization served as a runin with no intervention). Pain is measured using a 10-cm Visual Analogue Scale (VAS). Scores range from 0 to 10, where 0 cm represents 'no pain' and 10 cm represents 'the worst pain imaginable,' and higher scores indicate worse pain (greater pain intensity). The patient marks their pain level on the line, and the score is recorded in centimeters.
次要结局
未报告次要终点
研究者
Izmir Kavram
Assistant Professor Dr
Izmir Kavram Vocational School