The Effect of Shotblocker on Pain, Anxiety, and Satisfaction During Peripheral Intravenous Catheterization: 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
- 100
- 试验地点
- 1
- 主要终点
- Pain Intensity During Peripheral Intravenous Catheterization
研究概览
简要总结
This randomized controlled trial aims to evaluate the effect of the ShotBlocker device on pain, anxiety, and patient satisfaction during peripheral intravenous catheterization (PIVC). Peripheral intravenous catheterization is a commonly performed procedure in clinical settings and is often associated with pain and anxiety, which may negatively affect patient experience.
The ShotBlocker is a simple, non-pharmacological device designed to reduce pain by applying pressure and sensory stimulation at the injection site. Participants will be randomly assigned to either the intervention group, where the ShotBlocker will be used during the procedure, or the control group, where routine care will be provided.Pain will be assessed using the Visual Analog Scale (VAS). Anxiety and patient satisfaction will be evaluated using a visual analog-based scale supported , combining features of the Visual Analog Scale and the Wong-Baker Faces Scale, with scores ranging from 0 to 10. The findings of this study are expected to contribute to evidence-based nursing practices by providing an effective, low-cost, and non-invasive method for reducing procedural discomfort and improving patient experience during PIVC.
详细描述
Peripheral intravenous catheterization (PIVC) is one of the most frequently performed invasive procedures in clinical practice. Despite its routine nature, it is commonly associated with pain and anxiety, which may negatively influence patient comfort, satisfaction, and overall experience of care. Therefore, effective and practical strategies to reduce procedure-related discomfort are essential in nursing practice.
The ShotBlocker is a simple, non-pharmacological device designed to reduce pain by applying mechanical pressure and providing sensory distraction at the injection site. It is inexpensive, easy to use, and does not require additional training or pharmacological intervention, making it suitable for routine clinical use.
This study is designed as a randomized controlled trial to evaluate the effectiveness of the ShotBlocker device during PIVC. Participants will be randomly assigned to either the intervention group, in which the ShotBlocker will be applied during the catheterization procedure, or the control group, in which routine care will be provided without any additional intervention.
Pain intensity will be assessed using the Visual Analog Scale (VAS). Anxiety and patient satisfaction will be evaluated using a visual analog-based scale supported by combining features of the Visual Analog Scale and the Wong-Baker Faces Scale, with scores ranging from 0 to 10.
All procedures will be performed by trained healthcare professionals following standard clinical protocols. Data will be collected immediately after the procedure. The primary outcome of the study is pain intensity, while secondary outcomes include anxiety and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Blinding is not feasible due to the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 18 years and older Patients requiring peripheral intravenous catheterization Patients who are conscious and able to communicate Patients who agree to participate in the study and provide informed consent
排除标准
- •Patients with cognitive impairment or inability to communicate Patients with a history of chronic pain or current use of analgesics Patients with dermatological conditions or wounds at the catheterization site Patients who previously experienced peripheral intravenous catheterization within the last 24 hours Patients who refuse to participate in the study
研究组 & 干预措施
ShotBlocker Group
Participants will receive peripheral intravenous catheterization using the ShotBlocker device during the procedure.
干预措施: ShotBlocker (Device)
Control Group
Participants will receive routine peripheral intravenous catheterization without the use of the ShotBlocker device.
结局指标
主要结局
Pain Intensity During Peripheral Intravenous Catheterization
时间窗: Immediately after the procedure
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
次要结局
- Anxiety Level(Before and immediately after the procedure)
- Patient Satisfaction(Immediately after the procedure)
研究者
Emine Korkmaz
Assistant Professor
Kirsehir Ahi Evran Universitesi