The Effect of Innovative Cold Applications (Cold Spray and Buzzy Device) on Pain and Fear Associated With Penicillin Injection: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Procedural Pain Intensity
研究概览
简要总结
This study investigates the effect of cold spray and Buzzy devices on pain and fear experienced during penicillin injections. There are three groups: a cold spray and Buzzy device, and a control group. Penicillin injections are commonly used in clinical practice and can cause discomfort, pain, and fear, particularly in patients receiving intramuscular injections.
Cold spray and Buzzy devices are non-pharmacological methods that can help reduce pain and fear by providing a cooling effect and vibration at the injection site. Participants will be randomly assigned to one of the study groups, and their pain and fear levels during injection will be assessed using standardized measurement tools.
The results of this study are expected to contribute to improving patient comfort and supporting the use of simple, non-invasive methods to reduce pain and fear during injections.
详细描述
This randomized controlled study will be conducted to evaluate the effects of cold spray and the Buzzy device on pain and fear associated with penicillin injection. Eligible participants who require intramuscular penicillin injection will be randomly assigned to one of the study groups: cold spray, Buzzy device, or routine care (control group).
In the cold spray group, a topical cold spray will be applied to the injection site immediately before the injection. In the Buzzy device group, the Buzzy device will be placed near the injection site to provide cold and vibration during the injection. Participants in the control group will receive the injection according to standard clinical practice without any additional intervention.
Pain and fear levels will be assessed during the injection process using validated measurement tools. Data collection will be carried out by trained researchers following standardized procedures. The study will be conducted in accordance with ethical principles and relevant clinical research guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Eligibility Criteria
- •Inclusion Criteria:
- •Adults aged 18 years and older
- •Individuals scheduled to receive intramuscular penicillin injection
- •Able to communicate and report pain and fear levels
- •Willing to participate in the study
- •Provided written informed consent
排除标准
- •Known allergy or hypersensitivity to cold applications
- •Skin lesions, infection, or injury at the injection site
- •Neurological or psychiatric conditions that may affect pain or fear perception
- •Use of analgesic or anxiolytic medication prior to injection
- •Previous adverse reaction to intramuscular injections
研究组 & 干预措施
Control Group
In the Control group, a standard intramuscular penicillin injection is administered without any additional pain management intervention. All injections are performed using a standardized technique by the same nurse to ensure consistency.
干预措施: Control Group (Other)
Cold Spray Intervention Group
Two minutes prior to the procedure, patients will receive a brief explanation about the device. One minute before the injection, a cold spray will be applied to the individual for 30 seconds. Routine procedures will be followed during the injection.
干预措施: Cold Spray Intervention Group (Other)
Buzy Device Intervention Group
Two minutes prior to the procedure, patients will receive a brief explanation about the device. One minute before the injection, a cold spray will be applied to the individual for 30 seconds. Routine procedures will be followed during the injection.
干预措施: Buzy Device Intervention Group (Other)
结局指标
主要结局
Procedural Pain Intensity
时间窗: Within one minute before the penicillin injection 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.)
研究者
Zeliha CENGİZ
Associate Professor Dr.
Inonu University