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- Ensayo clínico 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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:
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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Sin intervención: Control
Control Arm Description: Participants in the control group, on the other hand, will
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fatigue Level
Periodo de tiempo: Baseline, Week 2, Week 4
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sleep Quality
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Trastornos del sueño y la vigilia
- Insuficiencia renal
- Trastornos del Sueño Intrínsecos
- Disomnias
- Condiciones Patológicas, Signos y Síntomas
- Trastornos de iniciación y mantenimiento del sueño
- Insuficiencia Renal Crónica
- Técnicas de investigación
- Métodos
Otros números de identificación del estudio
- 21.01.2026/2761
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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