The Effect of a 4-7-8 Breathing Exercise Program on the Management of Arteriovenous Fistula Intervention Pain in Hemodialysis Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Procedural pain intensity during arteriovenous fistula cannulation
研究概览
简要总结
For many hemodialysis patients, needle insertion into the vascular access site (fistula) is a significant source of pain and anxiety. In this study, patients will be guided to perform breathing exercises using the 4-7-8 breathing technique during needle insertion to reduce this pain. A total of 80 adult patients undergoing regular hemodialysis at Izmir Atatürk Training and Research Hospital will be randomly assigned to two groups: an intervention group and a control group. Participants in the intervention group will be taught a standardized intervention program consisting solely of the 4-7-8 breathing technique, to be applied before and during AVF cannulation. The program will be implemented during every hemodialysis session (three times a week) for one week. The technique will be explained in person by a research nurse before the first session, and patients will be provided with a short instructional video demonstrating the technique step by step. The video will be sent to patients' smartphones to encourage them to practice at home. Participants in the control group, however, will continue with their current routine hemodialysis care and standard cannulation procedures (without any structured breathing exercises). 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
This study was designed as a randomized controlled trial. The estimated sample size was calculated using the G*Power 3.1.9.7 software. The calculation was based on parameters from a preliminary study on the effects of breathing exercises in hemodialysis patients. For the independent two-group t-test, an analysis was conducted assuming 95% power (1-β), a significance level of α=0.05, and a large effect size (d=0.80). As a result, it was determined that 35 participants were needed in each group, for a total of 70 participants. Taking potential dropouts into account, the study will begin with a total of 80 participants, and analyses will be conducted using data from at least 70 participants who have completed the follow-up.
Inclusion Criteria: Age between 18 and 85 years.Receiving hemodialysis treatment three times per week.Literate (able to read and write).No hearing impairment.Native Turkish speaker.On hemodialysis for at least 6 months.Baseline pain score >3 on the Visual Analogue Scale (VAS).Willing to listen to music.
Exclusion Criteria: Presence of a psychological disorder.Communication problems.Diagnosis of cancer.Unwillingness to participate in the study.
Intervention Group Protocol:
Participants in the experimental group will be taught a standardized intervention program consisting solely of the 4-7-8 breathing technique, to be performed before and during AVF cannulation. The program will be implemented during every hemodialysis session for one week (three times a week). The technique will be explained in person by a research nurse before the first session, and patients will be provided with a short instructional video demonstrating the technique step by step. The video will be sent to patients' smartphones to encourage them to practice at home.
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)
盲法说明
Due to the nature of the interventions (listening to music and looking in a mirror), participants and the nurses providing care will not be blinded to the group assignment. However, the statistician conducting the final data analysis will be blinded to the group assignment.
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
Control
Participants in the control group, on the other hand, will continue with their current routine hemodialysis care and standard cannulation procedures (without any structured breathing exercises).
Experimental
During AVF cannulation, immediately before needle insertion, the research nurse will instruct the patient to begin the breathing exercise. The patient will perform the following cycle while the cannulation procedure (skin preparation, needle insertion) is underway:
- 4 seconds: Take a slow, deep breath through the nose.
- 7 seconds: Hold your breath.
- 8 seconds: Exhale slowly and completely through the mouth, pursing the lips slightly.
3. Number of Repetitions: This cycle will be repeated 5-6 times in succession, covering the duration of the cannulation procedure. The total duration of the exercise will be approximately 2-3 minutes.
干预措施: Breathing technique (Behavioral)
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 Konak
Assistant Professor Dr
Izmir Kavram Vocational School