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Effect of 4-7-8 Breathing on AV Fistula Needle Pain in Dialysis Patients: A Randomized Trial

8. juli 2026 opdateret af: Izmir Konak, Izmir Kavram Vocational School

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Detaljeret beskrivelse

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 (Güvener & Koç, 2025). 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.

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.
Ingen indgriben: Control
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procedural smerteintensitet under arteriovenøs fistelkanulation
Tidsramme: Procedure (under kanylering)
Smerteintensiteten oplevet af patienten umiddelbart efter nåleindsættelsen til hemodialyse. Dette primære resultat måles under den anden og tredje hemodialysesession efter randomisering (den første session efter randomisering fungerede som en indkøringsperiode uden intervention). Smerte måles ved hjælp af en 10 cm visuel analog skala (VAS). Scoreintervallet er fra 0 til 10, hvor 0 cm repræsenterer 'ingen smerte' og 10 cm repræsenterer 'den værste tænkelige smerte', og højere score indikerer værre smerte (større smerteintensitet). Patienten markerer deres smertegrad på linjen, og scoren registreres i centimeter.
Procedure (under kanylering)

Samarbejdspartnere og efterforskere

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Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. juli 2026

Primær færdiggørelse (Anslået)

25. juli 2026

Studieafslutning (Anslået)

30. januar 2027

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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