The Effect of Palm Stimulator Use During Peripheral Venous Catheterization on Pain, Fear, and Procedural Satisfaction in Cancer Patients Receiving Chemotherapy
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
- Procedural Pain Intensity
研究概览
简要总结
Purpose: The purpose of this study is to evaluate the effectiveness of a "Palm Stimulator" (a handheld device with blunt protrusions) in reducing pain, fear, and anxiety during peripheral venous catheterization (IV insertion) in adult cancer patients receiving chemotherapy.
Methods: This is a randomized controlled clinical trial. Participants will be randomly assigned to either the Experimental Group or the Control Group.
Experimental Group: During the IV insertion process, patients will hold and squeeze the Palm Stimulator in the palm of their non-procedural hand. The device is designed to provide intense tactile (touch) stimulation based on the "Gate Control Theory." Control Group: Patients will receive the standard routine care for IV insertion without any additional intervention.
Data Collection: Pain intensity will be measured using the Visual Analog Scale (VAS), while fear and anxiety levels will be assessed through VAS scales before and after the procedure. Patient satisfaction with the device will also be recorded.
Expected Outcome: The investigators hypothesize that the use of the Palm Stimulator will significantly decrease procedural pain and fear while increasing patient satisfaction compared to standard care. This study aims to provide a low-cost, non-pharmacological, and easy-to-use tool for oncology nurses to improve patient comfort during invasive procedures.
详细描述
Background: Cancer remains a complex disease that threatens individuals' lives across biopsychosocial dimensions. According to the World Health Organization, more than 19 million new cancer cases were diagnosed globally in 2020 (Sung et al., 2021). In modern oncology, chemotherapy is a primary treatment modality, with approximately 75% of these treatments administered intravenously (Duggan et al., 2024). Consequently, patients undergo repeated invasive procedures such as peripheral venous catheterization (PVC). Although PVC is a routine clinical task, it is a significant source of stress associated with pain, fear, and dissatisfaction. Inadequate management of procedural pain can lead to increased pain perception through peripheral and central sensitization, resulting in anticipatory anxiety and healthcare avoidance behaviors (Kapucu et al., 2017; Özırmak & Yayan, 2026).Oncology nurses bear critical responsibility in utilizing non-pharmacological methods to enhance patient comfort. Due to the side effects and cost limitations of pharmacological interventions, there is a need for low-cost, easy-to-integrate alternative approaches. While tactile stimulation-based interventions are promising, evidence regarding neurophysiologically based palmar stimulation is limited (Moustafa, 2024; Zengin & Yayan, 2022). The palm of the hand occupies a large representation area in the somatosensory cortex, allowing tactile stimuli from this region to be processed intensely by the central nervous system. Based on the Gate Control Theory, gripping the "Palm Stimulator" provides rapid sensory input that can inhibit pain perception at a neurophysiological level (Özırmak & Yayan, 2026).
Study Design and Setting: This study is designed as a randomized controlled clinical trial. It will be conducted at the Oncology Unit of Inönü University Turgut Ozal Medical Center between February and July 2026.
Intervention Protocol: Participants will be randomized into two groups using Research Randomizer software:
Palm Stimulator Group: 1-2 minutes before the procedure, patients will receive a brief orientation regarding the device. 20 seconds before PVC insertion, the device will be placed in the palm of the non-procedural hand. Patients will grip the device as the nurse applies the tourniquet. The tactile stimulation will continue throughout the needle entry and catheter stabilization.
Control Group: Participants will receive the standard routine PVC protocol. No additional intervention will be provided during the procedure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years.
- •Receiving chemotherapy treatment via peripheral venous catheter (PVC).
- •Cognitively capable of communicating and responding to pain, fear, and satisfaction scales.
- •Volunteering to participate and providing written informed consent.
排除标准
- •Diagnosis of chemotherapy-induced peripheral neuropathy or diabetic neuropathy.
- •Presence of active infection, open wound, scar tissue, or edema in the palm.
- •Use of analgesic medication within 4-6 hours before the procedure.
- •History of hemiplegia or movement restriction in the extremity to be used for the procedure.
研究组 & 干预措施
Palm Stimulator Group
1-2 minutes before the procedure, patients will receive a brief orientation regarding the device. 20 seconds before PVC insertion, the device will be placed in the palm of the non-procedural hand. Patients will grip the device as the nurse applies the tourniquet. The tactile stimulation will continue throughout the needle entry and catheter stabilization.
干预措施: Palm Stimulator Group (Device)
Control group
Participants will receive the standard routine PVC protocol. No additional intervention will be provided during the procedure.
结局指标
主要结局
Procedural Pain Intensity
时间窗: Within 1 minute after the completion of the peripheral venous catheterization procedure.
Procedural pain intensity will be measured using a 10-centimeter Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "unbearable pain."
次要结局
- Level of Procedural Fear(Immediately before the procedure and within 1 minute after the procedure.)
- Patient Satisfaction With the Procedure(Within 1 minute after the completion of the procedure.)
研究者
Zeliha CENGİZ
Associate Professor
Inonu University