Active — Not RecruitingNot Applicable

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 range0 Months – 7 Months

SexALL

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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

What they're measuring

Comprehension efficacy

Timeframe: Day 1

Trial details

NCT IDNCT07074925

SponsorUniversity of Texas at Austin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-15

View on ClinicalTrials.gov More Lumbar Puncture trials