Evaluation of the Effect of the Valsalva Maneuver on Invasive Pain During Arteriovenous Fistula Cannulation in Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Pain Intensity During AVF Cannulation Assessed by Visual Analogue Scale (VAS)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether the Valsalva maneuver reduces invasive pain during arteriovenous fistula (AVF) cannulation in adult hemodialysis patients. The main questions it aims to answer are:
Does the Valsalva maneuver effectively reduce pain intensity during AVF cannulation as measured by the Visual Analogue Scale (VAS)?
Is the Valsalva maneuver feasible, acceptable, and satisfactory for patients, and can it be sustainably implemented over multiple sessions?
Researchers will compare patients performing the Valsalva maneuver (intervention group) with those receiving standard care without any intervention (control group) to see if pain scores are significantly lower and whether patients are willing to continue using this technique voluntarily.
Participants will:
Receive training and supervised practice on the Valsalva maneuver before inclusion in the study
Perform the Valsalva maneuver during AVF cannulation in each hemodialysis session for 12 sessions
Complete VAS pain assessments after each session
Complete a patient satisfaction and feasibility form at the end of the study
详细描述
Arteriovenous fistula (AVF) cannulation is a frequent and essential procedure for patients receiving maintenance hemodialysis, yet it often causes moderate to severe pain and anxiety, which can negatively affect patients' treatment adherence and quality of life. Although pharmacological methods are commonly used to manage cannulation-related pain, they can be costly and have potential side effects. Therefore, there is increasing interest in simple, low-cost, non-pharmacological techniques.
The Valsalva maneuver is a physiological technique that increases intrathoracic pressure through forced exhalation against a closed airway, stimulating the vagus nerve and providing an antinociceptive effect. Previous studies have shown that the Valsalva maneuver reduces pain in various invasive procedures such as intravenous cannulation and spinal puncture; however, evidence for its efficacy during AVF cannulation in hemodialysis patients is limited and methodologically weak.
This randomized controlled, single-blind trial aims to evaluate the effectiveness of the Valsalva maneuver in reducing pain intensity during AVF cannulation among adult hemodialysis patients. The study also investigates the feasibility, sustainability, and patient satisfaction associated with the use of this maneuver.
Patients in the intervention group will receive training on the Valsalva maneuver and perform it during each cannulation session over 12 hemodialysis sessions. Pain intensity will be measured using the Visual Analogue Scale (VAS) immediately after each session. At the end of the study, patient feedback regarding the acceptability and ease of use of the maneuver will be collected through a structured form.
This study is designed to provide high-level evidence supporting a cost-effective, easily applicable, and non-pharmacological approach to pain management during AVF cannulation, potentially contributing to improved patient comfort and adherence to hemodialysis treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor (dialysis nurse) is blinded to group allocation to reduce assessment bias.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Receiving hemodialysis treatment via arteriovenous fistula for at least 3 months
- •No analgesic medication use within the past 24 hours
- •Systolic blood pressure between 90-160 mmHg and diastolic between 60-100 mmHg
- •Pain score ≥ 1 on Visual Analogue Scale during AVF cannulation
- •Able to perform the Valsalva maneuver (no contraindications)
- •No communication barriers or severe psychiatric disorders
- •Provided written informed consent
排除标准
- •Unable to correctly perform the Valsalva maneuver
- •Failed first cannulation attempt
- •History of acute myocardial infarction or malignant arrhythmia
- •Aneurysm, infection, edema, or scar tissue at AVF site
- •Pregnancy
- •Voluntary withdrawal from the study at any stage
- •Switching dialysis centers or requiring hospitalization during the study
研究组 & 干预措施
Valsalva Maneuver Group
Patients perform the Valsalva maneuver during AVF cannulation in each dialysis session.
干预措施: Valsalva Maneuver (Behavioral)
Control Group
Patients receive standard AVF cannulation care without any additional intervention.
结局指标
主要结局
Pain Intensity During AVF Cannulation Assessed by Visual Analogue Scale (VAS)
时间窗: Up to 12 hemodialysis sessions (approximately 3 months)
Pain intensity will be assessed using the Visual Analogue Scale (VAS), a 0-10 scale where 0 means no pain and 10 means the worst possible pain, immediately after each AVF cannulation session.
次要结局
- Patient Satisfaction With the Valsalva Maneuver(At the end of 12 hemodialysis sessions (approximately 3 months))
- Feasibility of Performing the Valsalva Maneuver(Up to 12 hemodialysis sessions (approximately 3 months))
研究者
Cansu POLAT DÜNYA
PhD, Associate Professor
Istanbul University