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OpenTrials
Completed

NCT Number: NCT03677219

Lumbar Puncture Video Study

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Introduction: Lumbar puncture is a safe procedure commonly performed on pediatric patients for a variety of indications. Parents are informed of and consented to this procedure, but are often left with concerns and doubts. There are no published studies of the nature of the concerns of parents in North America, and no studies examining a process to improve pediatric lumbar puncture consent. Here the investigators conduct a randomized control study of a short educational video on a handheld device as an adjunct to the formal consent process.

Methods: 72 patients were enrolled, evenly divided between the control arm and video arm of the study. A survey was provided examining four key indices: parent self-rated understanding of the procedure, their perception of its safety, their perception of the painfulness and their overall comfort with their child undergoing LP. In addition, demographic characteristics such as prior experience with LP or epidural, language spoken at home, age of the child and indication for lumbar puncture, as well as qualitative information about parent concerns were collected.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

An Educational Video to Address Parental Concern in Lumbar Puncture Consent: A Randomized Control Trial

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 19, 2018
Registry last updated
Sep 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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