- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07700680
Effect of 4-7-8 Breathing on AV Fistula Needle Pain in Dialysis Patients: A Randomized Trial
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
Studieoversigt
Status
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:
- Pre-Procedure Preparation: Immediately before needle insertion, the research nurse will instruct the patient to begin the breathing exercise.
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.
- 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
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
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
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:
|
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.
|
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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
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Smerte
- Neurologiske manifestationer
- Karsygdomme
- Hjerte-kar-sygdomme
- Patologiske processer
- Mandlige urogenitale sygdomme
- Patologiske Tilstande, Anatomiske
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Kronisk sygdom
- Sygdomsegenskaber
- Nyreinsufficiens
- Medfødte abnormiteter
- Kardiovaskulære abnormiteter
- Vaskulære misdannelser
- Fistel
- Arteriovenøse misdannelser
- Vaskulær fistel
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Patologiske tilstande, tegn og symptomer
- Tegn og symptomer
- Smerte, Procedurel
- Nyreinsufficiens, kronisk
- Arteriovenøs fistel
Andre undersøgelses-id-numre
- 04.02.2026/ 2760
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