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Video-Assisted Informed Consent for Neonatal Lumbar Puncture

NCT07074925 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-20

No results posted yet for this study

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.

Conditions

  • Lumbar Puncture
  • Pediatrics
  • Emergency Department Patient
  • Informed Consent

Interventions

OTHER

Video assisted informed consent

The 2-minute video (available in English or Spanish) will use animation to explain the neonatal LP procedure, benefits, and risks.

OTHER

Standard consent

The standard consent group will receive usual procedure description and consent.

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Matthew Wilkinson, MD, MPH · The University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-11-15
Completion
2025-11-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07074925 on ClinicalTrials.gov