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

NCT07700680 | Not Yet Recruiting

• 1 other identifier: 04.02.2026/ 2760
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Diseases; Pain, Procedural; Arteriovenous Fistula

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Procedure (during cannulation)

Study Arms (2)

Experimental

EXPERIMENTAL

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

Control

NO INTERVENTION

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).

Interventions

Breathing technique BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Bakircay University: collaborator
• Izmir Kavram Vocational School: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Pain, Procedural; Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Dr

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

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 14, 2026
• Study Start: July 20, 2026
• Primary Completion: July 25, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07