A Study to Assess the Effect of Temperature of Needle on Perception of Pain during Administration of Intramuscular Injection of Benzathine Penicillin to Patients Having Rheumatic Heart Disease
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- subjective pain perception when administering intramuscular penicillin injection using cold needle as compared to room temperature needle as assessed by numerical rating scale
研究概览
简要总结
Aim of the study: Rheumatic heart disease (RHD) patients are committed to lifelong secondary prophylaxis with Intramuscular Benzathine Penicillin. The study was conducted as a part of Master’s dissertation to evaluate the effect of cold needle to decrease the pain associated with this injection. Material and Methods: A randomized crossover single blinded study was conducted at a tertiary care facility of India among 100 patients whoreceived two injections 21 days apart, with room temperature needle and cold needle (0-2 degree Celsius) in random order. Pain was evaluated using numerical rating scale and biophysiological measures. Analysis was done using STATA 9.1; Paired t test and Wilcoxon signed rank test were applied with level of significance set at p< 0.05.
Results: There was a significant decrease in subjective pain score when cold needle was used as compared to room temperature needle. (3.37 ±1.75 vs 5.58 ±1.68, p ≤ 0.0001). Conclusion: Cold needle decreased pain perception of patients receiving intramuscular injection of Benzathine Penicillin. Pain reducing technique may be useful in improving compliance of patients receiving benzathine penicillin.
Keywords: Rheumatic heart disease, Benzathine penicillin, Cold needle
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 13.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients and parents giving informed consent.
- •2.Patients receiving benzathine penicillin intramuscular injection every 21 days and capable of giving adequate response.
- •3.Absence of any problem/ conditions resulting in pain.
排除标准
- •1.Muscular dystrophies 2.Disoriented patients 3.Diabetic neuropathy.
结局指标
主要结局
subjective pain perception when administering intramuscular penicillin injection using cold needle as compared to room temperature needle as assessed by numerical rating scale
时间窗: Immediately after administering injection
次要结局
- Change in objective pain assessment(Blood Pressure and Pulse) when cold needle was used compared to room temperature(Five minutes before and after administering intramuscular injection)