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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05252377
Other study ID # 2021-20-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 5, 2022
Est. completion date May 1, 2022

Study information

Verified date September 2022
Source Istanbul Demiroglu Bilim University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date May 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Breathing Exercise
The patient will be asked to close their eyes He will be asked to relax his head and neck in a semi-sitting position in bed The patient will be asked to breathe through the nose for 3 seconds by counting Then he will be told to hold his breath for 3 seconds As the last step, he will be asked to breathe out again in 3 seconds.

Locations

Country Name City State
Turkey Demiroglu Bilim University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Demiroglu Bilim University

Country where clinical trial is conducted

Turkey, 

References & Publications (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. — View Citation

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. Review. — View Citation

Crespo Montero R, Rivero Arellano F, Contreras Abad MD, Martínez Gómez A, Fuentes Galán MI. Pain degree and skin damage during arterio-venous fistula puncture. EDTNA ERCA J. 2004 Oct-Dec;30(4):208-12. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline Invasive Pain at 12 Dialysis Session 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. At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)]
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