4-7-8 Breathing for Fatigue and Sleep Management in Hemodialysis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIzmir Kavram Vocational School
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Advanced reading comprehension problems
Advanced hearing impairment
Presence of sleep apnea
Known psychiatric illness.
Trial design
Design model
Parallel
Treatments tested in this trial
Breathing technique
BehavioralA 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Fatigue Level
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.
Time frame
Baseline, Week 2, Week 4Secondary outcomes
1
Sleep Quality
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.
Time frame
Baseline, Week 2, Week 4Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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