Lumbar Puncture Video Study

NCT03677219 | Completed

• 1 other identifier: H14-00981
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to improve the lumbar puncture (LP) consent process for pediatric patients. Though a commonly performed and safe procedure, LP can be anxiety-provoking for parents. By using an educational video on a handheld device at the time of consent, we hope to improve parent understanding and comfort with the procedure.

Conditions

Consent

Keywords

consent; lumbar puncture; pediatric; video

Outcome Measures

Primary Outcomes (1)

• Likert Scale for Parent Understanding, Pain perception, Safety Perception and Comfort

  4 separate Likert scales from 1-10 (1 is low, 10 is high) for each of understanding of procedure, pain perception, safety perception and comfort with procedure, each individual scale will be reported. For understanding, safety and comfort, a higher score represents better outcome, for pain perception a lower score represents better outcome.

  within 10 minutes of consent discussion (controls) or viewing the video (video group)

Study Arms (2)

Control

NO INTERVENTION

Parents in this arm receive the standard lumbar puncture consent discussion and answer a survey about their concerns, and do not view an educational video.

Video

EXPERIMENTAL

Parents in this arm receive the standard lumbar puncture consent discussion and answer a survey about their concerns, then view a 2 minute educational video and respond to a second survey.

Other: Educational Video

Interventions

Educational Video OTHER

The educational video is a 2 minute video depicting a live lumbar puncture on an infant interwoven with animations of the relevant anatomy.

Video

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• parent of a patient less than 17 years of age
• parent present for consent
• patient under the care of the neurology team (directly or consulting)
• consenting physician able to communicate with parent directly or through a translator

You may not qualify if:

• patients with emergent indications for lumbar puncture, such as bacterial meningitis
• parent's unable to communicate in English and no translator was available
• consent not performed in person (over the phone)

Sponsors & Collaborators

• University of British Columbia: lead

Related Publications (1)

• Dunbar M, Paton G, Singhal A. An Educational Video Improves Consent in Pediatric Lumbar Puncture: A Randomized Control Trial. Pediatr Neurol. 2019 Nov;100:74-79. doi: 10.1016/j.pediatrneurol.2019.04.014. Epub 2019 May 13.

  PMID: 31201072 DERIVED

Study Officials

• Ashutosh Singhal, MD MSc

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The caregiver obtaining consent for lumbar puncture does not know if the parent will be randomized to see the video; the parent is not aware they may be randomized to see a video when they respond to the first survey about their concerns.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Parents are randomized to either view an educational video or not

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: September 19, 2018
• Study Start: January 1, 2015
• Primary Completion: May 30, 2017
• Study Completion: May 30, 2017
• Last Updated: September 19, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share