NCT07427875

Brief Summary

This study aims to evaluate the effects of guided 4-7-8 and diaphragmatic breathing exercises performed during arteriovenous fistula cannulation on pain, anxiety, and comfort levels in patients undergoing hemodialysis treatment. Hemodialysis patients often experience pain and anxiety during fistula cannulation, which can negatively affect the treatment process and patient comfort. The study will be conducted as a three-arm randomized controlled trial. Participants will be randomly assigned to the 4-7-8 breathing exercise group, the diaphragmatic breathing exercise group, or the control group receiving usual care. In the intervention groups, breathing exercises will be performed with guidance before and during cannulation. The study anticipates that breathing exercises will reduce pain and anxiety, increase comfort levels, and contribute as an easily applicable, side-effect-free method to nursing care. The findings are expected to support the use of non-pharmacological interventions in hemodialysis patients.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress54%
Feb 2026Oct 2026

First Submitted

Initial submission to the registry

February 8, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 8, 2026

Last Update Submit

February 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anxiety level during arteriovenous fistula cannulation

    State anxiety will be measured using the State-Trait Anxiety Inventory (STAI) state subscale. The subscale consists of 20 items rated on a four-point Likert scale. Total scores range from 20 to 80, with higher scores indicating greater anxiety. Anxiety will be assessed during arteriovenous fistula cannulation to evaluate the immediate effect of the intervention.

    During arteriovenous fistula cannulation

Secondary Outcomes (8)

  • Pain intensity during arteriovenous fistula cannulation

    During arteriovenous fistula cannulation.

  • Systolic blood pressure

    During arteriovenous fistula cannulation.

  • Diastolic blood pressure

    During arteriovenous fistula cannulation

  • Heart rate

    During arteriovenous fistula cannulation.

  • Respiratory rate

    During arteriovenous fistula cannulation

  • +3 more secondary outcomes

Other Outcomes (1)

  • Comfort level during arteriovenous fistula cannulation

    During arteriovenous fistula cannulation.

Study Arms (3)

4-7-8 Breathing Exercise Group

EXPERIMENTAL

Participants in this experimental group will receive guided 4-7-8 breathing exercises before and during arteriovenous fistula cannulation in addition to routine hemodialysis care. The 4-7-8 breathing technique consists of inhaling through the nose for 4 seconds, holding the breath for 7 seconds, and exhaling slowly through the mouth for 8 seconds. The breathing exercises will be performed under researcher guidance according to a standardized protocol during each cannulation session.

Behavioral: Guided 4-7-8 Breathing Exercise

Diaphragmatic Breathing Exercise Group

EXPERIMENTAL

Participants in this experimental group will receive guided diaphragmatic breathing exercises before and during arteriovenous fistula cannulation in addition to routine hemodialysis care. The intervention involves slow and deep breathing with diaphragmatic expansion, emphasizing abdominal movement rather than chest movement. The breathing exercises will be performed under researcher guidance according to a standardized protocol during each cannulation session.

Behavioral: Guided Diaphragmatic Breathing Exercise

Control Group (Usual Care)

OTHER

Participants in this control group will receive routine nursing care during arteriovenous fistula cannulation according to standard clinical practice. No breathing exercise or additional intervention will be applied.

Other: routine care

Interventions

Katılımcılar, rutin hemodiyaliz bakımına ek olarak, arteriyovenöz fistül kanülasyonu öncesinde ve sırasında rehberli 4-7-8 nefes egzersizi yapacaklardır. Bu teknik, 4 saniye boyunca burundan nefes almak, 7 saniye boyunca nefesini tutmak ve 8 saniye boyunca ağızdan yavaşça nefes vermekten oluşur. Egzersiz, her kanülasyon seansı sırasında standart bir protokole göre araştırmacıların rehberliğinde uygulanacaktır.

Also known as: 4-7-8 Breathing Technique
4-7-8 Breathing Exercise Group

Participants will perform guided diaphragmatic breathing exercises before and during arteriovenous fistula cannulation in addition to routine hemodialysis care. The intervention involves slow and deep breathing with diaphragmatic expansion, emphasizing abdominal movement rather than chest movement. The breathing exercises will be administered under researcher guidance according to a standardized protocol during each cannulation session.

Also known as: Diaphragmatic Breathing Technique
Diaphragmatic Breathing Exercise Group

Participants in this group will receive routine nursing care during arteriovenous fistula cannulation according to standard clinical practice. No breathing exercise or additional intervention will be applied.

Also known as: Usual Care
Control Group (Usual Care)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be 18 years of age or older
  • Have been receiving regular hemodialysis treatment for at least 6 months
  • Undergo hemodialysis via an AV fistula
  • Have the physical and cognitive ability to perform breathing exercises during cannulation
  • Have a cognitive level sufficient to communicate

You may not qualify if:

  • Those with pain level 4 or higher
  • Those using painkillers and antidepressants
  • Those with a history of acute complications
  • Patients using a vascular access route other than an AV fistula
  • Those with severe cognitive impairment or a neurological disease that impairs communication
  • Those with severe cardiopulmonary disease that may contraindicate breathing exercises Patients with an infection requiring contact isolation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Faculty of Nursing Çiftlikköy Campus 33343, Yenişehir / Mersin

Mersin, Yenişehir, 33000, Turkey (Türkiye)

Location

Related Publications (2)

  • İlgin, V. E., & Yayla, A. (2023). Effect of the 4-7-8 breathing technique on pain level and sleep quality of patients after laparoscopic bariatric surgery: A randomized controlled study. Bariatric Surgical Practice and Patient Care, 18, 225-232. https://doi.org/10.1089/bari.2022.0044

    BACKGROUND
  • Serbest Baz, A. N. (2025). The effect of using the 4-7-8 breathing technique on postoperative shoulder pain and pulmonary functions after laparoscopic cholecystectomy (Unpublished doctoral dissertation). Mersin University.

    RESULT

Related Links

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Emine KAPLAN SERİN, Associate Professor

    Mersin University, Faculty of Nursing, Department of Internal Medicine Nursing, Mersin/ Türkiye.

    STUDY DIRECTOR

Central Study Contacts

Semra USTA Usta, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 8, 2026

First Posted

February 23, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to ethical considerations, protection of patient privacy, and the absence of participant consent for data sharing beyond the scope of this study.

Locations