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ACTIVE NOT RECRUITING
NCT07074925
NA

Video-Assisted Informed Consent for Neonatal Lumbar Puncture

Sponsor: University of Texas at Austin

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

0 Months - 7 Months

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-10-01

Completion Date

2025-11-15

Last Updated

2025-07-20

Healthy Volunteers

No

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.

Locations (1)

Dell Children's Medical Center

Austin, Texas, United States