4-7-8 Breathing for Fatigue and Sleep Management in Hemodialysis

NCT07700693 | Not Yet Recruiting

• 1 other identifier: 21.01.2026/2761
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Kidney Diseases; Insomnia; 4-7-8 Breathing Technique

Keywords

4-7-8 Breathing Technique; Non-pharmacological Pain Management; Hemodialysis; insomnia

Outcome Measures

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.

  Baseline, Week 2, Week 4

Secondary Outcomes (1)

• Sleep Quality

  Baseline, Week 2, Week 4

Study Arms (2)

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: Breathing technique

Control

NO INTERVENTION

Control Arm Description: Participants in the control group, on the other hand, will

Interventions

Breathing technique BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Advanced reading comprehension problems
• Advanced hearing impairment
• Presence of sleep apnea
• Known psychiatric illness.

Sponsors & Collaborators

• Izmir Kavram Vocational School: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Dr

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel groups for the duration of the study.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07