An interventional study of Breathing technique in Chronic Kidney Diseases, Pain, Procedural and Arteriovenous Fistula, sponsored by Izmir Kavram Vocational School. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Izmir Kavram Vocational School · Not applicable, Interventional, and Supportive care
For many hemodialysis patients, needle insertion into the vascular access site (fistula) is a significant source of pain and anxiety. In this study, patients will be guided to perform breathing exercises using the 4-7-8 breathing technique during needle insertion to reduce this pain. A total of 80 adult patients undergoing regular hemodialysis at Izmir Atatürk Training and Research Hospital will be randomly assigned to two groups: an intervention group and a control group. Participants in the intervention group will be taught a standardized intervention program consisting solely of the 4-7-8 breathing technique, to be applied before and during AVF cannulation. The program will be implemented during every hemodialysis session (three times a week) for one week. The technique will be explained in person by a research nurse before the first session, and patients will be provided with a short instructional video demonstrating the technique step by step. The video will be sent to patients' smartphones to encourage them to practice at home. Participants in the control group, however, will continue with their current routine hemodialysis care and standard cannulation procedures (without any structured breathing exercises). The results of this study may provide nurses and patients with easy-to-use, evidence-based options to make hemodialysis needle procedures less painful and stressful.
This study was designed as a randomized controlled trial. The estimated sample size was calculated using the G*Power 3.1.9.7 software. The calculation was based on parameters from a preliminary study on the effects of breathing exercises in hemodialysis patients. For the independent two-group t-test, an analysis was conducted assuming 95% power (1-β), a significance level of α=0.05, and a large effect size (d=0.80). As a result, it was determined that 35 participants were needed in each group, for a total of 70 participants. Taking potential dropouts into account, the study will begin with a total of 80 participants, and analyses will be conducted using data from at least 70 participants who have completed the follow-up.
Inclusion Criteria: Age between 18 and 85 years.Receiving hemodialysis treatment three times per week.Literate (able to read and write).No hearing impairment.Native Turkish speaker.On hemodialysis for at least 6 months.Baseline pain score >3 on the Visual Analogue Scale (VAS).Willing to listen to music.
Exclusion Criteria: Presence of a psychological disorder.Communication problems.Diagnosis of cancer.Unwillingness to participate in the study.
Intervention Group Protocol:
Participants in the experimental group will be taught a standardized intervention program consisting solely of the 4-7-8 breathing technique, to be performed before and during AVF cannulation. The program will be implemented during every hemodialysis session for one week (three times a week). The technique will be explained in person by a research nurse before the first session, and patients will be provided with a short instructional video demonstrating the technique step by step. The video will be sent to patients' smartphones to encourage them to practice at home.
4-7-8 Breathing Technique Implementation Protocol (During Cannulation):
During AVF cannulation, while the patient is sitting or lying down in a comfortable position, the following protocol will be followed:
Simultaneous Application: While the cannulation procedure (skin cleansing, needle insertion) is ongoing, the patient will perform the following cycle:
Assessment:
Immediately after the cannulation procedure and breathing exercise are completed, the patient will be asked to rate the intensity of their pain on a Visual Analog Scale (VAS) on a scale from 0 (no pain) to 10 (unbearable pain). This assessment will be repeated after each cannulation session throughout the four-week intervention period.
Being 18-85 years of age or older
Exclusion Criteria:
Having a psychological disorder
During AVF cannulation, immediately before needle insertion, the research nurse will instruct the patient to begin the breathing exercise. The patient will perform the following cycle while the cannulation procedure (skin preparation, needle insertion) is underway: * 4 seconds: Take a slow, deep breath through the nose. * 7 seconds: Hold your breath. * 8 seconds: Exhale slowly and completely through the mouth, pursing the lips slightly. 3\. Number of Repetitions: This cycle will be repeated 5-6 times in succession, covering the duration of the cannulation procedure. The total duration of the exercise will be approximately 2-3 minutes.
Behavioral: Breathing technique
Participants in the control group, on the other hand, will continue with their current routine hemodialysis care and standard cannulation procedures (without any structured breathing exercises).
A non-pharmacological behavioral intervention utilizing the 4-7-8 breathing technique. Prior to the first session, a researcher nurse provides brief face-to-face training and an instructional video sent to participants' smartphones for home practice. During AVF cannulation in a comfortable position, the cycle begins just before and continues through needle insertion: inhale for 4 seconds, hold for 7, exhale for 8 through pursed lips. This 5-6-cycle sequence covers the entire \~2-3 minute procedure. Applied three times weekly for four weeks, with pain assessed post-cannulation via VAS (0-10). The intervention reduces procedural pain by activating the parasympathetic system, promoting relaxation, decreasing anxiety, and modulating central pain processing.
Procedural pain intensity during arteriovenous fistula cannulation
Pain intensity experienced by the patient immediately following the needle insertion for hemodialysis. This primary outcome is measured during the second and third hemodialysis sessions following randomization (the first session post-randomization served as a runin with no intervention). Pain is measured using a 10-cm Visual Analogue Scale (VAS). Scores range from 0 to 10, where 0 cm represents 'no pain' and 10 cm represents 'the worst pain imaginable,' and higher scores indicate worse pain (greater pain intensity). The patient marks their pain level on the line, and the score is recorded in centimeters.
Time frame: Procedure (during cannulation)
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Izmir Kavram Vocational School