- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07700693
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Aucune intervention: Control
Control Arm Description: Participants in the control group, on the other hand, will
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fatigue Level
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Sleep Quality
Délai: Baseline, Week 2, Week 4
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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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies du système nerveux
- Les troubles mentaux
- Processus pathologiques
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladie chronique
- Attributs de la maladie
- Troubles du sommeil et de l'éveil
- Insuffisance rénale
- Troubles du sommeil, intrinsèques
- Dyssomnies
- Conditions pathologiques, signes et symptômes
- Troubles de l'initiation et du maintien du sommeil
- Insuffisance rénale chronique
- Techniques d'investigation
- Méthodes
Autres numéros d'identification d'étude
- 21.01.2026/2761
Informations sur les médicaments et les dispositifs, documents d'étude
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