Effect of Breathing Exercises Applied to Hemodialysis Patients on Anxiety, Fatigue and Quality of Life
Exercise
1 other identifier
interventional
52
1 country
1
Brief Summary
Breathing exercises are one of the non-pharmacological methods frequently used in health care in recent years. The aim of this study is to evaluate the effect of breathing exercises on fatigue, anxiety symptoms and quality of life in hemodialysis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2024
CompletedFirst Posted
Study publicly available on registry
September 25, 2024
CompletedStudy Start
First participant enrolled
February 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2025
CompletedJune 29, 2025
June 1, 2025
3 months
September 22, 2024
June 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Beck Anxiety Inventory
Beck Anxiety Inventory (BAI) is designed to measure the frequency of anxiety symptoms experienced by an individual. The scale, consisting of 21 items, is a Likert-type assessment scale scored between 0-3. Individuals rate each item by giving a score between 0-3 to determine how uncomfortable they have felt for the symptom in each item "including the day of the application, in the last week". The scale scores between 0-63. The high total score indicates the high level of anxiety experienced by the person. While 13 of the items describe physical symptoms, 3 reveal the cognitive aspects of anxiety. 3 items have a physical quality as well as a cognitive quality. Therefore, the BAI includes physiological, affective and cognitive symptoms of anxiety. The Cronbach Alpha value of the scale was determined as 0.92.
6 week
Quality of Life Scale
Quality of Life Scale (SF-12): SF-12; consists of two dimensions measuring physical (6 statements) and mental/psychological (6 statements) functioning. It includes various Likert-type statements (2-point Likert; yes-no or 5-point Likert; always, often, sometimes, very little, never etc.) regarding general health status, activity limits, depression, energy level etc. High scores indicate high quality of life.
6 week
Piper Fatigue Scale
Piper Fatigue Scale (PFS): PFS consists of 22 questions and subjectively evaluates fatigue perception. It has four sub-dimensions: the behavior/severity sub-dimension, which evaluates the effect and severity of fatigue on daily life activities; the affective sub-dimension, which covers the emotional meaning attributed to fatigue; the sensory sub-dimension, which reflects the mental, physical and emotional symptoms of fatigue; and the cognitive/spiritual sub-dimension, which reflects the degree to which fatigue affects cognitive functions and mood. The total score of the scale varies between 0 and 10. A score of 0 indicates no fatigue, 1-3 indicates mild fatigue, 4-6 indicates moderate fatigue, and 7-10 indicates severe fatigue.
6 week
Study Arms (2)
Experimental (breathing exercise)
EXPERIMENTALThe researcher has a certificate in breathing exercises. Those who consent to participate in the study that meets the research criteria will be given training with a prepared training brochure about correct breathing technique, introduction and function of the diaphragm muscle, box breathing technique, diaphragm breathing technique and benefits of correct breathing before the exercise. Box breathing technique will be applied in addition to standard treatment, 3 sets per day (morning, noon and evening) for 6 weeks, 10 repetitions in each set. Diaphragm breathing exercise will be applied in addition to standard treatment, lasting 2 minutes in the first week, then increasing each week and reaching 12 minutes in the 6th week, as 3 sets (morning, noon and evening).
Control
NO INTERVENTIONThe control group will receive standard care. No intervention will be applied to these patients during the follow-up period, only data collection forms will be applied. Data collection forms will be collected in the same time period as the intervention group.
Interventions
The researcher has a certificate in breathing exercises. Those who consent to participate in the study that meets the research criteria will be given training with a prepared training brochure about correct breathing technique, introduction and function of the diaphragm muscle, box breathing technique, diaphragm breathing technique and benefits of correct breathing before the exercise. Box breathing technique will be applied in addition to standard treatment, 3 sets per day (morning, noon and evening) for 6 weeks, 10 repetitions in each set. Diaphragm breathing exercise will be applied in addition to standard treatment, lasting 2 minutes in the first week, then increasing each week and reaching 12 minutes in the 6th week, as 3 sets (morning, noon and evening).
Eligibility Criteria
You may qualify if:
- Being over the age of 18
- Being willing to participate in the study
- Speaking and understanding Turkish
- Having started hemodialysis treatment at least 6 months ago
You may not qualify if:
- Being on hemodialysis treatment with a diagnosis of stage 4 renal failure
- Being on hemodialysis treatment due to acute renal failure
- Having a malignancy related to the respiratory system (bronchus or lung)
- Having chest pain
- Having previously done box breathing and diaphragmatic breathing exercises/receiving training
- Having cognitive dysfunction
- Not giving consent to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neşe Uysal
Amasya, 0500, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Mahmut Zengin
Amasya University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 22, 2024
First Posted
September 25, 2024
Study Start
February 17, 2025
Primary Completion
May 26, 2025
Study Completion
June 23, 2025
Last Updated
June 29, 2025
Record last verified: 2025-06