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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Anxiety level during arteriovenous fistula cannulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Guided 4-7-8 Breathing Exercise (Behavioral)
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.
干预措施: Guided Diaphragmatic Breathing Exercise (Behavioral)
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.
干预措施: routine care (Other)
结局指标
主要结局
Anxiety level during arteriovenous fistula cannulation
时间窗: 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.
次要结局
- 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)
- Oxygen saturation(During arteriovenous fistula cannulation.)
- Body temperature(During arteriovenous fistula cannulation)
- Body Mass Index (BMI)(During arteriovenous fistula cannulation.)
研究者
Emine Kaplan Serin
Associate Professor
Mersin University