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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Diseases; Insomnia; 4-7-8 Breathing Technique
• Intervention / Treatment: Behavioral: Intervention

Detailed Description

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 (Güvener & Koç, 2025). 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Intervention; 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.
No Intervention: Control; Control Arm Description: Participants in the control group, on the other hand, will

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 2, Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 2, Week 4

Collaborators and Investigators

• Sponsor: Izmir Kavram Vocational School

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: insomnia; Hemodialysis; Non-pharmacological Pain Management; 4-7-8 Breathing Technique
• Additional Relevant MeSH Terms: Urogenital Diseases; Nervous System Diseases; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Sleep Wake Disorders; Renal Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Pathological Conditions, Signs and Symptoms; Sleep Initiation and Maintenance Disorders; Renal Insufficiency, Chronic; Investigative Techniques; Methods
• Other Study ID Numbers: 21.01.2026/2761

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No