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Effect of 4-7-8 Breathing on AV Fistula Needle Pain in Dialysis Patients

The Effect of a 4-7-8 Breathing Exercise Program on the Management of Arteriovenous Fistula Intervention Pain in Hemodialysis Patients: A Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07700680
Enrollment
80
Registered
2026-07-14
Start date
2026-07-20
Completion date
2027-01-30
Last updated
2026-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula, Chronic Kidney Diseases, Pain, Procedural

Keywords

Non-pharmacological Pain Management, Hemodialysis, Vascular Access, Cannulation Pain, 4-7-8 Breathing Technique

Brief summary

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.

Detailed description

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: 1. Pre-Procedure Preparation: Immediately before needle insertion, the research nurse will instruct the patient to begin the breathing exercise. 2. Simultaneous Application: While the cannulation procedure (skin cleansing, needle insertion) is ongoing, the patient will perform the following cycle: * 4 seconds: Take a slow, deep breath through the nose. * 7 seconds: Hold the 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 to cover the duration of the cannulation procedure. The total duration of the exercise will be approximately 2-3 minutes. 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.

Interventions

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.

Sponsors

Izmir Kavram Vocational School
Lead SponsorOTHER
Izmir Bakircay University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Masking description

Due to the nature of the interventions (listening to music and looking in a mirror), participants and the nurses providing care will not be blinded to the group assignment. However, the statistician conducting the final data analysis will be blinded to the group assignment.

Intervention model description

Participants were randomly assigned in a 1:1 ratio to one of two parallel groups for the duration of the study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Being 18-85 years of age or older * Receiving HD treatment 3 days a week * Being able to read and write * Having no hearing impairment * Having Turkish as their native language * Having received HD treatment for at least 6 months * Having a VAS pain score \>3 * Agreeing to listen to music

Exclusion criteria

* Having a psychological disorder * Having communication problems * Having cancer * Not wanting to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Procedural pain intensity during arteriovenous fistula cannulationProcedure (during 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 16, 2026