Comparison of Three Different Pain and Anxiety Reducing Methods in Adult Patients Undergoing Bone Marrow Puncture
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 748
- 试验地点
- 2
- 主要终点
- Reduction of pain and anxiety during and after the punction procedure
研究概览
简要总结
The purpose of this study is to investigate and compare the effects of three different methods for reducing pain and anxiety in adult patients undergoing puncture of the bone marrow. The investigated methods are: cognitive behavioural technique, administration of a sedative drug(Midazolam) and administration of an analgetic drug (Piritramid)prior to the procedure. Additionally, there are two comparison groups in which the patients receive either placebo treatment or no treatment at all.
详细描述
The puncture of the bone marrow is a routine medical procedure which is often performed in the field of hematology/oncology. When carefully and appropriately performed, the puncture of the bone marrow has a very low rate of complications and is generally safe for the patient. However, it is an invasive and painful procedure associated with anxiety, especially in patients undergoing repeated punctures. Therefore an appropriate preparation of the patient for the puncture is essential in order to minimize the stress experienced during the procedure. In this regard, there are numbers of both pharmacological and non-pharmacological interventions in pedriatric patients aimed at reducing the punction related pain and anxiety in this patients. Nevertheless an evidence based approach for the pretreatment of the patients is yet to be established. The aim of this study is to investigate three different methods for reducing the pain and anxiety associated with the puncture of the bone marrow in adult patients. Two of the of the investigated methods involve pretreatment of the patients with pharmacological agents (sedative drug or analgetic drug), whereas the third method involves cognitive behavioural pretreatment in form of an audio material. The patients in the control group receive placebo injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for both first or repeated punction of the bone marrow
- •Age between 18 and 85 years
- •Written informed consent
排除标准
- •Contraindication for a punction of the bone marrow
- •Administration of benzodiazepines or analgetic drugs prior to the bone marrow punction
- •Known hypersensitivity to benzodiazepines or Piritramid
- •Known contraindication to benzodiazepines (Myasthenia gravis in particular) or Piritramid (Pheochromocytoma or conditions affecting the consciousness)
- •Poor general condition (ECOG Performance Status 3,4; Karnofsky Index < 50%)
- •Addictive disorders
- •Administration of antidepressive drugs
- •Administration of drugs that potentially depress the respiratory function
- •Severe cardio-circulatory or respiratory insufficiency, sleep apnea syndrome
- •Known bradycardia
- •History of syncope(s) of unclear etiology
- •Pregnancy or lactation
结局指标
主要结局
Reduction of pain and anxiety during and after the punction procedure
Comparison of the efficacy of the three investigated methods to the placebo group, as well as to the group not receiving any pretreatment at all.
次要结局
- Duration of the effective pain reduction in each of the investigated groups
- Assessment of the quality of life in the period immediately after the bone marrow puncture