Effect of Hypericum Perforatum Oil on Prevention Ecchymosis and Pain Associated With Subcutaneous Low Molecular Weight Heparin Injection: a Self-controlled Single-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Ecchymosis
研究概览
简要总结
Low molecular weight heparin is a drug with anticoagulant and antithrombotic effects. This drug is frequently administered subcutaneously to patients by nurses. Complications such as pain, ecchymosis and hematoma may commonly occur at the injection site. This study investigated the effect of Hypericum Perforatum oil in preventing pain and ecchymosis after subcutaneous injection low molecular weight heparin. This quasi-experimental and single blinded study was conducted with 160 patients in a coronary intensive care unit. The researcher nurse applied 5-6 drops of Hypericum Perforatum oil to one arm of the patients 2 hours before the injection. The other arm of the patient was considered as the control arm. A total of 320 injections were administered. The evaluation of the injection sites was performed by two other researchers at 48th hours. The data were analyzed using Wilcoxon and McNemar test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Two researchers do not know which site was injected.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •Normal platelet value,
- •Normal international normalised ratio (INR) and prothrombin time (PTZ) values,
- •No infection, scar tissue or incision in the lateral upper arm
排除标准
- •Pregnancy
- •Administration of haemodialysis
结局指标
主要结局
Ecchymosis
时间窗: 48 hours after injection
Ecchymosis was evaluated at 48th hours after injection in the study. A transparent ruler that allows millimetric measurement was used to measure the ecchymosis at the injection site. The discoloration at the injection site was measured in millimeter. Ecchymosis was defined as an area of discolored skin of more than 2 mm appearing 48th hours after administration. The maximum horizontal extent (diameter) of the bruise was recorded regardless of whether the bruise was regular or uneven in shape at the time of measurement. According to previous studies, bruise size was analyzed according to 3 categories: no bruise (0-1 mm), small bruise (2-5 mm) and large bruise (\>5 mm). In our study, bruises \>2 mm in size was accepted as ecchymosis.
Pain point
时间窗: 48 hours after injection
The patient's pain was evaluated with Visual Analogue Scale (VAS) 48 hours after the injection. Visual Analogue Scale is a reliable pain assessment scale to determine the pain felt by patients at the injection site. The VAS is a self-report scale consisting of a horizontal line (10 cm long) with anchor points "no pain" and "worst possible pain". The patient is asked to mark the place on this line that best describes the intensity of pain. A marking of "0" means "no pain". Marking "10" means "'intolerable pain". In this way, the patient scores his/her pain between 1-10.
次要结局
未报告次要终点
研究者
HATİCE DEMİRDAĞ
Assistant Proffessor
Uskudar University