An interventional study of Guided 4-7-8 Breathing Exercise and Guided Diaphragmatic Breathing Exercise in Hemodialysis, Arteriovenous Fistula Cannulation and Breathing Exercises, sponsored by Emine Kaplan Serin. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-07.
Sponsored by Emine Kaplan Serin · Not applicable, Interventional, and Supportive care
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.
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.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 90 is above the median of 70 across 1,904 interventional studies indexed under Pain.
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Inclusion criteria
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
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 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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During arteriovenous fistula cannulation
Heart rate
Time Frame: Pre-cannulation and post-cannulation Unit of Measure: beats per minute (bpm)
Time frame: During arteriovenous fistula cannulation.
Respiratory rate
Time Frame: Pre-cannulation and post-cannulation Unit of Measure: breaths per minute
Time frame: During arteriovenous fistula cannulation
Oxygen saturation
Time Frame: Pre-cannulation and post-cannulation Unit of Measure: percentage (%)
Time frame: During arteriovenous fistula cannulation.
Body temperature
Time Frame: Pre-cannulation Unit of Measure: °C
Time frame: During arteriovenous fistula cannulation
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).
Time frame: During arteriovenous fistula cannulation.
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.
Time frame: During arteriovenous fistula cannulation.
Plan to share: No — 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.
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