Pain Clinical Trial
Official title:
Investigation of the Effect of Breathing Exercise on Invasive Pain Associated With Arteriovenous Fistula Cannulation in Hemodialysis Patients.
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 |
Verified date | September 2022 |
Source | Istanbul Demiroglu Bilim University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Demiroglu Bilim University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul Demiroglu Bilim University |
Turkey,
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
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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