The Effect of the 4-7-8 Breathing Exercise Program on the Management of Fatigue and Sleep Disorders 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
- Fatigue Level
研究概览
简要总结
For many hemodialysis patients, fatigue and sleep disturbances are common and debilitating side effects that severely impact daily life and quality of life. In this study, patients will be taught a simple breathing exercise called the 4-7-8 technique to help manage these symptoms. 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 receive a face-to-face training session from a research nurse and a short instructional video sent to their smartphones to encourage daily home practice, especially before bedtime. The program will be continued over the study period. Participants in the control group will continue with their current routine hemodialysis care without any structured breathing exercises. Fatigue levels, sleep quality, and daytime sleepiness will be measured in both groups before and after the program using validated questionnaires. The results of this study may provide nurses and patients with a safe, cost-effective, non-drug option to improve symptom management and overall well-being in hemodialysis patients.
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 for at least 3 months; no diagnosis of malignant respiratory disease (e.g., bronchial or lung cancer); no pathological condition affecting consciousness or focus (e.g., dialysis dementia or uremic encephalopathy); native Turkish speaker.
Exclusion Criteria: Advanced reading comprehension problems; advanced hearing impairment; presence of sleep apnea; known psychiatric illness.
Intervention Group Protocol: Participants in the experimental group will be taught a standardized program consisting solely of the 4-7-8 breathing technique. The intervention will last four weeks. The technique will be demonstrated face-to-face by a research nurse, and patients will be provided with a short instructional video that explains the technique step by step. The video will be sent to patients' smartphones to encourage them to practice independently at home.
4-7-8 Breathing Technique Instructions:
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
- •Age between 18 and 85 years
- •Receiving hemodialysis treatment for at least 3 months
- •No diagnosis of malignant respiratory disease (e.g., bronchial or lung cancer)
- •No pathological condition affecting consciousness or focus (e.g., dialysis dementia or uremic encephalopathy)
- •Native Turkish speaker
排除标准
- •Advanced reading comprehension problems
- •Advanced hearing impairment
- •Presence of sleep apnea
- •Known psychiatric illness.
研究组 & 干预措施
Control
Control Arm Description: Participants in the control group, on the other hand, will
Experimental
Arm Description:During daily practice sessions, patients will be instructed to sit or lie down in a comfortable position and begin the breathing exercise. The patient will perform the following cycle:
- 4 seconds: Take a slow, deep breath through the nose.
- 7 seconds: Hold the breath.
- 8 seconds: Exhale slowly and completely through the mouth, with lips slightly pursed (making a slight hissing sound).
Number of Repetitions: This cycle will be repeated 10 times consecutively per session, with a total duration of approximately 10-15 minutes. Participants will be asked to perform this routine twice daily (once during the day and once before bedtime) throughout the four-week intervention period. On hemodialysis session days, the exercise will be performed under the supervision of the research nurse to ensure adherence.
干预措施: Breathing technique (Behavioral)
结局指标
主要结局
Fatigue Level
时间窗: Baseline, Week 2, Week 4
Fatigue severity experienced by the patient over the past month. This primary outcome is measured at baseline (pre-test), at the end of the second week, and at the end of the fourth week of the intervention. Fatigue is measured using the Chalder Fatigue Scale (CFS), an 11-item self-report scale. The first 7 items assess physical fatigue and the last 4 items assess cognitive fatigue. Each item is scored on a 4-point Likert scale (0-3), with total scores ranging from 0 to 33. Higher scores indicate greater fatigue severity. The patient completes the scale independently, and the total score is recorded.
次要结局
- Sleep Quality(Baseline, Week 2, Week 4)
研究者
Izmir Konak
Assistant Professor Dr
Izmir Kavram Vocational School