Video-Assisted Informed Consent for Neonatal Lumbar Puncture
United States100 participantsStarted 2023-10-01
Plain-language summary
The purpose of this study is to explore the effectiveness of video-assisted neonatal lumbar puncture consent processes against a conventional consent discussion to inform parents about pediatric lumbar puncture in the pediatric ED. We hypothesize that having a visual aid in addition to the verbal information presented in the consent process will lead to increased parent comprehension, decision-making, and satisfaction with the consent process. Furthermore, the findings from this study may have broader implications for improving the informed consent process for other medical procedures and interventions in pediatric settings.
Who can participate
Age range
0 Months – 7 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Children, age 0-7 months old who are recommended for lumbar puncture procedure during an ED visit.
* Caregiver fluent in English or Spanish
Exclusion Criteria:
* Previous enrollment in the study, i.e., the patient has been previously part of the current LP study. This will be confirmed by the study coordinator, PI, or co-I.
* Parent/guardian unwilling to complete surveys
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.