Mersin University Faculty of Nursing Çiftlikköy Campus 33343, Yenişehir / Mersin
Mersin, Yenişehir, 33000, Turkey (Türkiye)
NCT Number: NCT07427875
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Mersin, Yenişehir, 33000, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
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
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
Time frame: 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 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.
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
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.
Time Frame: Pre-cannulation and post-cannulation Unit of Measure: beats per minute (bpm)
Time frame: During arteriovenous fistula cannulation
Time Frame: Pre-cannulation and post-cannulation Unit of Measure: breaths per minute
Time frame: During arteriovenous fistula cannulation.
Time Frame: Pre-cannulation and post-cannulation Unit of Measure: percentage (%)
Time frame: During arteriovenous fistula cannulation
Time Frame: Pre-cannulation Unit of Measure: °C
Time frame: During arteriovenous fistula cannulation.
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 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.
Emine KAPLAN SERIN
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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