Clinical trial NCT05252377: Breathing Exercise and Invasive Pain at Hemodialysis Patients
Official title: Investigation of the Effect of Breathing Exercise on Invasive Pain Associated With Arteriovenous Fistula Cannulation in Hemodialysis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Arteriovenous Fistula
Breathing Exercise
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2022-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline Invasive Pain at 12 Dialysis Session
timeFrame: At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)]
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demiroglu Bilim University
Study officials:
References:
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.
citation: 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.
citation: 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.