Video-Assisted Informed Consent for Neonatal Lumbar Puncture

NCT07074925 | Active Not Recruiting

• 1 other identifier: 00004883
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Comprehension efficacy

  Efficacy of the video intervention on parents' comprehension compared to the conventional consent discussion of the lumbar puncture procedure. Using the Delphi method, a knowledge survey was designed. The survey consists of 10 questions about the lumbar puncture procedure that are discussed in both the standard consent discussion and in the video. Each question has one correct response. The investigators will compare correct responses (individual questions and aggregate scores) between the two groups. The survey will be given to the parents/caregivers immediately after the procedure informed consent process.

  Day 1

Secondary Outcomes (1)

• Parental satisfaction

  Day 1

Study Arms (2)

Video assisted consent

EXPERIMENTAL

The intervention group (n=50) will receive procedure information via a video explanation. The 2-minute video (available in English or Spanish) will use animation to explain the neonatal LP procedure, benefits, and risks.

Other: Video assisted informed consent

Standard consent

ACTIVE COMPARATOR

The control group (n=50) will receive standard procedure explanation.

Other: Standard consent

Interventions

Video assisted informed consent OTHER

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

Video assisted consent

Standard consent OTHER

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

Standard consent

Eligibility Criteria

• Age: 0 Months - 7 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children, age 0-7 months old who are recommended for lumbar puncture procedure during an ED visit.
• Caregiver fluent in English or Spanish

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Related Publications (5)

• Spencer SP, Stoner MJ, Kelleher K, Cohen DM. Using a Multimedia Presentation to Enhance Informed Consent in a Pediatric Emergency Department. Pediatr Emerg Care. 2015 Aug;31(8):572-6. doi: 10.1097/PEC.0000000000000513.

  PMID: 26221786 BACKGROUND

• Richardson V. Patient comprehension of informed consent. J Perioper Pract. 2013 Jan-Feb;23(1-2):26-30. doi: 10.1177/1750458913023001-204.

  PMID: 23413533 BACKGROUND

• Sherlock A, Brownie S. Patients' recollection and understanding of informed consent: a literature review. ANZ J Surg. 2014 Apr;84(4):207-10. doi: 10.1111/ans.12555.

  PMID: 24812707 BACKGROUND

• COMMITTEE ON BIOETHICS. Informed Consent in Decision-Making in Pediatric Practice. Pediatrics. 2016 Aug;138(2):e20161484. doi: 10.1542/peds.2016-1484.

  PMID: 27456514 BACKGROUND

• Leazer RC. Evaluation and Management of Young Febrile Infants: An Overview of the New AAP Guideline. Pediatr Rev. 2023 Mar 1;44(3):127-138. doi: 10.1542/pir.2022-005624.

  PMID: 36854834 BACKGROUND

Study Officials

• Matthew Wilkinson, MD, MPH

  The University of Texas at Austin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 20, 2025
• Study Start: October 1, 2023
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)