Anxiety, Arteriovenous Fistula Cannulation, Breathing Exercises, Comfort, Hemodialysis, Pain
Conditions
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.
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.
Interventions
BEHAVIORALGuided 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.
BEHAVIORALGuided 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.
OTHERroutine 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.
Sponsors
Emine Kaplan Serin
Mersin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety level during arteriovenous fistula cannulation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity during arteriovenous fistula cannulation | 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. |
| Systolic blood pressure | 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. |
| Diastolic blood pressure | 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. |
| Heart rate | During arteriovenous fistula cannulation. | Time Frame: Pre-cannulation and post-cannulation Unit of Measure: beats per minute (bpm) |
| Respiratory rate | During arteriovenous fistula cannulation | Time Frame: Pre-cannulation and post-cannulation Unit of Measure: breaths per minute |
| Oxygen saturation | During arteriovenous fistula cannulation. | Time Frame: Pre-cannulation and post-cannulation Unit of Measure: percentage (%) |
| Body temperature | During arteriovenous fistula cannulation | Time Frame: Pre-cannulation Unit of Measure: °C |
| Body Mass Index (BMI) | 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). |
Countries
Turkey (Türkiye)
Contacts
STUDY_DIRECTOREmine KAPLAN SERİN, Associate Professor
Mersin University, Faculty of Nursing, Department of Internal Medicine Nursing, Mersin/ Türkiye.
Outcome results
None listed