4-7-8 Breathing for Fatigue and Sleep Management in Hemodialysis
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
調査の概要
詳細な説明
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:
Patients will be asked to sit or lie down in a comfortable position and follow the cycle below:
4 seconds: Take a slow, deep breath in 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).
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 the technique twice daily (once during the day and once before bedtime). To monitor adherence, patients will be given a simple practice log, and weekly reminders will be provided via phone calls or messages. On hemodialysis session days, the exercise will be performed during the HD session under the supervision of the research nurse.
Control Group Protocol: Participants in the control group will continue with their current routine hemodialysis care and will not be included in any structured breathing exercise program.
Assessment: Fatigue (Chalder Fatigue Scale), sleep quality (Jenkins Sleep Scale), and daytime sleepiness (Epworth Sleepiness Scale) will be assessed at three time points: at baseline (pre-test), at the end of the second week, and at the end of the fourth week of the intervention.
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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:
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. |
A non-pharmacological behavioral intervention utilizing the 4-7-8 breathing technique.
Prior to the first session, a research nurse provides brief face-to-face training and an instructional video sent to participants' smartphones for home practice.
During daily practice sessions in a comfortable position, the cycle is performed: inhale for 4 seconds, hold for 7, exhale for 8 through pursed lips.
This 10-cycle sequence lasts approximately 10-15 minutes per session.
Applied twice daily (once during the day and once before bedtime) for four weeks, with fatigue, sleep quality, and daytime sleepiness assessed via validated questionnaires (Chalder Fatigue Scale, Jenkins Sleep Scale, Epworth Sleepiness Scale) at baseline, week 2, and week 4.
The intervention aims to reduce fatigue and sleep disturbances by activating the parasympathetic system, promoting relaxation, decreasing anxiety, and modulating autonomic balance.
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介入なし:Control
Control Arm Description: Participants in the control group, on the other hand, will
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fatigue Level
時間枠:Baseline, Week 2, Week 4
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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.
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Baseline, Week 2, Week 4
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sleep Quality
時間枠:Baseline, Week 2, Week 4
|
Sleep quality experienced by the patient over the past week.
This secondary 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.
Sleep quality is measured using the Jenkins Sleep Scale (JSS), a 4-item self-report scale.
Each item assesses the frequency of specific sleep problems on a 0-5 scale, with total scores ranging from 0 to 20.
Higher scores indicate poorer sleep quality.
The patient completes the scale independently, and the total score is recorded.
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Baseline, Week 2, Week 4
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 21.01.2026/2761
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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慢性腎臓病の臨床試験
Breathing techniqueの臨床試験
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Royal Brompton & Harefield NHS Foundation TrustNational Institute for Health Research, United Kingdom完了
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Luzerner Kantonsspital完了