Breathing Exercises for Pain and Anxiety During Arteriovenous Fistula Cannulation

The Effect of Guided 4-7-8 and Diaphragmatic Breathing Exercises During Arteriovenous Fistula Cannulation on Pain, Anxiety, and Comfort Levels in Hemodialysis Patients: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Hemodialysis; Anxiety; Comfort; Breathing Exercises; Arteriovenous Fistula Cannulation
• Intervention / Treatment: Behavioral: Guided 4-7-8 Breathing Exercise; Behavioral: Guided Diaphragmatic Breathing Exercise; Other: routine care

Detailed Description

This study is a randomized controlled trial designed to evaluate the effects of non-pharmacological breathing exercises applied during arteriovenous fistula cannulation on pain, anxiety, and comfort levels in hemodialysis patients. The research will be conducted within routine clinical practice, and no additional invasive procedures will be performed beyond standard care.

During the study process, guided breathing exercises will be applied to patients in the intervention groups before and during arteriovenous fistula cannulation, which is routinely performed in the hemodialysis unit. Patients in the control group will continue to receive standard nursing care without any additional intervention. The breathing exercises used in this study are complementary nursing interventions that are easy to apply in clinical settings, cost-free, and associated with no known serious adverse effects.

All measurement tools used in the study are validated and reliable instruments, and the collected data will be used solely for research purposes. Participants' personal information will be kept confidential, data will be coded and analyzed anonymously, and no identifying information will be shared with third parties. Participation in the study is entirely voluntary, and participants may withdraw from the study at any time without providing a reason. Withdrawal from the study will not affect patients' ongoing treatment processes or their right to receive healthcare services.

The breathing exercises will be administered with careful consideration of patients' physical and cognitive conditions. If any clinical risk or contraindication to the breathing exercises is identified, the intervention will be discontinued immediately. Participant safety will be prioritized throughout the study, and appropriate clinical interventions will be provided promptly in the event of any discomfort or adverse situation.

The findings obtained from this study are expected to contribute evidence-based data to nursing care practices related to arteriovenous fistula cannulation in hemodialysis patients and to support the integration of effective non-pharmacological interventions into clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Yenişehir
    • Mersin, Yenişehir, Turkey (Türkiye), 33000
      • Mersin University Faculty of Nursing Çiftlikköy Campus 33343, Yenişehir / Mersin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• 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
• Volunteer to participate in the study and sign the written informed consent form Exclusion criteria
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4-7-8 Breathing Exercise Group; 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; 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.; Other Names: 4-7-8 Breathing Technique
Experimental: Diaphragmatic Breathing Exercise Group; 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; 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.; Other Names: Diaphragmatic Breathing Technique
Other: Control Group (Usual Care); 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; 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.; Other Names: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	Time Frame: Baseline Unit of Measure: kg/m² Description: BMI will be calculated using the formula: weight (kg) divided by height squared (m²). Height (meters) and weight (kilograms) are measured separately and combined to obtain a single reported value (kg/m²).	During arteriovenous fistula cannulation.
Pain intensity during arteriovenous fistula cannulation	Pain intensity will be measured using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity. Pain will be assessed during arteriovenous fistula cannulation to evaluate the effect of the intervention.	During arteriovenous fistula cannulation.
Systolic blood pressure	Time Frame: Pre-cannulation and post-cannulation Unit of Measure: mmHg Description: Higher values indicate higher blood pressure and potentially worse physiological response.	During arteriovenous fistula cannulation.
Diastolic blood pressure	Time Frame: Pre-cannulation and post-cannulation Unit of Measure: mmHg Description: Higher values indicate higher blood pressure and potentially worse physiological response.	During arteriovenous fistula cannulation
Heart rate	Time Frame: Pre-cannulation and post-cannulation Unit of Measure: beats per minute (bpm)	During arteriovenous fistula cannulation.
Respiratory rate	Time Frame: Pre-cannulation and post-cannulation Unit of Measure: breaths per minute	During arteriovenous fistula cannulation
Oxygen saturation	Time Frame: Pre-cannulation and post-cannulation Unit of Measure: percentage (%)	During arteriovenous fistula cannulation.
Body temperature	Time Frame: Pre-cannulation Unit of Measure: °C	During arteriovenous fistula cannulation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort level during arteriovenous fistula cannulation	Comfort level will be measured using the Hemodialysis Comfort Scale Version II. The scale consists of 9 items rated on a five-point Likert scale. Total scores range from 9 to 45, with higher scores indicating greater comfort. Comfort will be assessed during arteriovenous fistula cannulation to evaluate the effect of the intervention.	During arteriovenous fistula cannulation.

Collaborators and Investigators

• Sponsor: Emine Kaplan Serin
• Collaborators: Mersin University
• Investigators: Study Director: Emine KAPLAN SERİN, Associate Professor, Mersin University, Faculty of Nursing, Department of Internal Medicine Nursing, Mersin/ Türkiye.

Publications and helpful links

General Publications

• 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
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Actual): April 1, 2026
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Anxiety Disorders
• Other Study ID Numbers: 78017789/050.01.04/3392078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No