All inpatient neurological patients for whom there is a medical indication for elective lumbar puncture to investigate their neurological symptoms are eligible for participation, provided they do not meet the exclusion criteria of this study. This includes a broad spectrum of neurological symptoms, signs or conditions and is not limited to one or more specific diagnoses.
Conditions
Interventions
Group 1: Experimental group with optimized communication techniques during oral medical risk information for lumbar puncture
Group 2: The control group (Treatment As Usual, TAU) without the use of spe
Sponsors
Universitätsklinikum Essen, Klinik für Neurologie, Professur für klinische Neurowissenschaften
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Impairment due to headache, rated on a numeric rating scale from 0-10, since lumbar puncture, or since the last inquiry timepoint, respectively. Collected at 3h, 24h and 72h after lumbar puncture | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Expectation of unwanted effects - Headache incidence - Reported current headache intensity - Mean and maximum headache intensity since lumbar puncture, or since the last inquiry timepoint, respectively - Headache duration - Use of pain medication against headache - Warmth and competence of the informing physician - Satisfaction with the procedure - Anxiety, Arousal | — |
Countries
Germany
Contacts
Public ContactLivia Asan
Universitätsklinikum Essen, Klinik für Neurologie
Outcome results
None listed