DRKS00032272招募中Unknown
The effects of risk communication strategies before lumbar puncture on the occurence of post-dural-puncture headache- a randomized controlled clinical study - OPTI-LP (Occurrence of Post-dural-puncture headache with Techniques for informed consent before lumbar puncture)
niversitätsklinikum Essen, Klinik für Neurologie, Professur für klinische Neurowissenschaften0 个研究点目标入组 80 人开始时间: 2023年11月27日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Existence of a medical indication for the execution of an elective, i.e., planned lumbar puncture for diagnostic purposes during an inpatient stay in the neurological clinic at the University Medicine Essen. The indication is confirmed by the study physician as well as the physicians primarily treating the patient on the ward.
排除标准
- •Emergency indication for lumbar puncture, limited capacity for providing informed consent, decreased level of consciousness, restricted ability to answer questions from study personnel, therapeutic purpose of lumbar puncture, history of lumbar puncture, marked scoliosis, extreme obesity with BMI > 50, or other medical conditions likely to complicate lumbar puncture, indication for performing lumbar puncture under fluoroscopy, The presence of a chronic headache disorder (defined as 15 or more headache days per month), headaches as the primary symptom leading to admission or to the indication of a lumbar puncture.
- •Criteria for discontinuing study participation:
- •Lumbar puncture no longer indicated by medical personnel or the patient declines the procedure; unsuccessful lumbar puncture (discontinuation at the patient's request or due to difficulty in execution, with no further attempt by medical personnel), retroactively withdrawing consent for study participation or use of the data, occurrence of a contraindication against lumbar puncture (coagulation disorder; anticoagulation not paused), other medical circumstances (e.g., discharge before the puncture, significant deterioration in health, necessary examinations or medical measures preventing patient interview, e.g., due to absence), unplanned unavailability of study personnel without adequate replacement or feasibility of a rescheduling of the lumbar puncture, detection of increased cerebrospinal fluid pressure during lumbar puncture and medical decision on the necessity of pressure relief through cerebrospinal fluid drainage, extended inability to establish contact with the patient, or the patient grossly violates study instructions.
研究者
相似试验
已完成
3 期
A scientific trial to determine the effect of risk-related information on awareness, behavior and change in risk of heart disease among people having hypertension, diabetes, or other heart-disease causing risky behavior.CTRI/2020/10/028614AIIMS BHOPA159
已完成
不适用
Optimizing risk-communication by presenting convertability of of individual life expectancy or rather cost-effectivenessI25.19I63.0E11I10Cerebral infarction due to thrombosis of precerebral arteriesType 2 diabetes mellitusEssential (primary) hypertensionDRKS00004933Abteilung für Allgemeinmedizin303
已完成
不适用
The effect of an online diabetes risk communication intervention for people impacted by alcohol and other drugs: A randomized controlled trialType 2 DiabetesACTRN12621000112864niversity of Wollongong1,282
进行中（未招募）
不适用
Forms of risk communication in context with the German Diabetes Risk Score to investigate risk perception and user understandingRisk perception of diabetesDRKS00013355German Institute of Human Nutrition Potsdam-Rehbruecke3,399
已完成
不适用
Intentions for Cancer Screening in Older AdultsThe effect of communication strategies about cancer screening cessationMental Health - Studies of normal psychology, cognitive function and behaviourPublic Health - Health promotion/educationCancer - BreastCancer - ProstateACTRN12618001306202School of Public Health, University of Sydney271