Lumbar Puncture Video Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-05-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Consent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parents are randomized to either view an educational video or not

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Educational Video

Intervention Type OTHER

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

Interventions

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Educational Video

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

Intervention Type OTHER

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes