- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05252377
Breathing Exercise and Invasive Pain at Hemodialysis Patients
September 8, 2022 updated by: Nurten Ozen, Istanbul Demiroglu Bilim University
Investigation of the Effect of Breathing Exercise on Invasive Pain Associated With Arteriovenous Fistula Cannulation in Hemodialysis Patients.
Non-pharmacological approaches applied in the prevention of invasive pain due to cannulation in patients treated with arteriovenous fistula and hemodialysis; It is also a cost-effective method that prevents the patient from feeling pain from the application.
Breathing exercises are a method that can be easily applied before the cannulation procedure.
Although it is seen that there are limited number of studies on the subject in the literature, it was observed that the duration of breathing exercise application was short (two weeks) in one study and the duration was not specified in the other.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
An average of 312 cannulations per year is performed in a patient who is treated for chronic hemodialysis and has arteriovenous fistula.
Patients state that they experience moderate to severe pain at a rate of 57-60.9%
when accessing the arteriovenous.
In cases where access to the fistula cannot be achieved at one time, patients may experience pain due to; patients experience non-compliance with dialysis treatment and their quality of life is adversely affected.
This situation causes an increase in the mortality rate, especially with cardiovascular and respiratory system complications.
In recent years, breathing exercise, which is one of the methods of distraction, has been used to reduce the invasive pain experienced during blood collection and cannulation procedures.
By increasing lung ventilation with breathing, the amount of oxygen entering the body is maximized, and this causes relaxation in the patient.
This relaxation also causes the person to relax and reduce the pain they will feel.
Although studies have found that breathing exercise is effective in reducing invasive pain; No information was given about the exercise method and duration.
Although in practice, holding the patient's breath during venipuncture and performing the cannulation procedure while giving it is a method frequently applied by the nurse, no study with high evidence supporting the situation has been found in the literature.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey, 34384
- Demiroglu Bilim University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Hemodialysis treatment with arteriovenous for at least 3 months
- Hemodialysis treatment is applied for 3 days and 4 hours a week.
- Between the ages of 18-65
- Pain score ≥ 2 as assessed by Visual Analogue Scale during cannulation of the arteriovenous fistula
- Absence of advanced heart failure, asthma and chronic obstructive pulmonary disease
- Able to communicate in Turkish
- Not having any psychiatric disorder that prevents communication
- Agreeing to participate in the research
Exclusion Criteria:
- Inability to do breathing exercises properly
- Presence of infection, edema and scar tissue in the area where the arteriovenous fistula is located
- Using pain medication before hemodialysis treatment
- Two or more cannulation attempts for arteriovenous fistula in the same session
- Presence of neuropathy and peripheral vascular disease
- Pregnancy
- Withdrawal from the study at any stage of the research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breathing Exercise Group
Breathing exercise program; It was prepared by the researchers in accordance with the literature and based on the studies in which breathing exercise was applied to reduce invasive pain experienced during cannulation, blood collection and postoperative pain.
Patients will be given an exercise based on rhythmic breathing.
The exercise will be started before the cannulation application, the patient will be told to perform the breathing exercise twice, and he will be asked to continue doing the breathing exercise until the cannulation process is completed.
The patient will wait by taking five normal breaths between each breathing exercise.
The patient will be told that he can count by using his fingers in the steps he is asked to count up to three.
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No Intervention: Control Group
No intervention will be made by the researcher on the patients in this group, and a pain assessment will be made by the nurse in charge of dialysis immediately after the cannulation procedure by the dialysis nurse working in the unit.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline Invasive Pain at 12 Dialysis Session
Time Frame: At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)]
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It will be assessed total 12 times at the end of the dialysis session with Visual Analogue.
Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. Pain increases as the score increases.
The high point describes bad outcome.
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At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)]
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Alzaatreh MY, Abdalrahim MS. Management Strategies for Pain Associated with Arteriovenous Fistula Cannulation: An Integrative Literature Review. Hemodial Int. 2020 Jan;24(1):3-11. doi: 10.1111/hdi.12803. Epub 2019 Dec 3.
- Aitken E, McLellan A, Glen J, Serpell M, Mactier R, Clancy M. Pain resulting from arteriovenous fistulae: prevalence and impact. Clin Nephrol. 2013 Nov;80(5):328-33. doi: 10.5414/CN107917.
- Crespo Montero R, Rivero Arellano F, Contreras Abad MD, Martinez Gomez A, Fuentes Galan MI. Pain degree and skin damage during arterio-venous fistula puncture. EDTNA ERCA J. 2004 Oct-Dec;30(4):208-12. doi: 10.1111/j.1755-6686.2004.tb00369.x.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2022
Primary Completion (Actual)
April 1, 2022
Study Completion (Actual)
May 1, 2022
Study Registration Dates
First Submitted
February 14, 2022
First Submitted That Met QC Criteria
February 14, 2022
First Posted (Actual)
February 23, 2022
Study Record Updates
Last Update Posted (Actual)
September 9, 2022
Last Update Submitted That Met QC Criteria
September 8, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Congenital Abnormalities
- Pathological Conditions, Anatomical
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Respiratory Aspiration
- Fistula
- Arteriovenous Fistula
Other Study ID Numbers
- 2021-20-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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