The Effect of Standardizing Procedures for Subcutaneous Injections of Low-molecular-weight Heparin on Patients With Cardiovascular Diseases: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Bruising
研究概览
简要总结
Improper subcutaneous administration of LMWH may cause complications at the injection site. Standardized protocol for subcutaneous LMWH injections in patient with cardiovascular diseases is warranted to ensure consistent best practices in clinical settings.
详细描述
This study examines the effect of standardized protocol in reducing complications for patients with cardiovascular disease.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The administrative staff, who will be responsible for data collection, will be masked for the group allocation during the whole process. The patients will be masked for the intervention purpose.
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
- •patients who are in cardiac care units suffering from cardiovascular diseases prescribed with LMWH injections two times per day
排除标准
- •cognitively impaired
- •unconscious
- •refuse to participate
研究组 & 干预措施
Active Control
The control group participants will receive the usual practice of subcutaneous LMWH injection administered by nurses.
干预措施: Active Control (Other)
Standardized injection protocol
The intervention group participants will receive standardized LMWH injection administered by nurses.
干预措施: Standardized injection protocol (Other)
结局指标
主要结局
Bruising
时间窗: 24 hours, 48 hours, 72 hours
The bruising diameter will be measured by a ruler and the incidence of bruising will be recorded.
Pain
时间窗: Immediately after injection, 24 hours, 48 hours, 72 hours
Patients' pain levels are assessed using the Verbal Descriptor Scale: 'severe pain,' 'moderate pain,' 'mild pain,' and 'no pain.' 'Severe pain' indicates the worst outcome, followed by 'moderate pain,' then 'mild pain,' with 'no pain' representing the best outcome.
Bruise size
时间窗: 24 hours, 48 hours, 72 hours
The bruising length and width will be measured by a ruler and the incidence of bruising will be recorded.
Pain level
时间窗: Immediately after injection, 24 hours, 48 hours, 72 hours
Patients' pain levels are assessed using the Numeric Rating Scale: from o to 10, with "10" representatin the worst outcome and with '0' representing the best outcome.
Bruising
时间窗: 24 hours, 48 hours, 72 hours
The bruising diameter will be measured by a ruler and the incidence of bruising will be recorded.
Pain
时间窗: Immediately after injection, 24 hours, 48 hours, 72 hours
Patients' pain levels are assessed using the Verbal Descriptor Scale: 'severe pain,' 'moderate pain,' 'mild pain,' and 'no pain.' 'Severe pain' indicates the worst outcome, followed by 'moderate pain,' then 'mild pain,' with 'no pain' representing the best outcome.
次要结局
- Patient Experience(Immediately after receiving the injection)
- Communicative Competence(Immediately before and after injection)
研究者
CHEUNG Pui Yu Frankie
Assistant Professor of Practice
The Hong Kong Polytechnic University