Lumbar Puncture Video Study

September 17, 2018 updated by: Ash Singhal, University of British Columbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
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.
Experimental: Video
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.
The educational video is a 2 minute video depicting a live lumbar puncture on an infant interwoven with animations of the relevant anatomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 10 minutes of consent discussion (controls) or viewing the video (video group)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ashutosh Singhal, MD MSc, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

May 30, 2017

Study Completion (Actual)

May 30, 2017

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

September 19, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • H14-00981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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