Clinical trial NCT03677219: Lumbar Puncture Video Study
Official title: An Educational Video to Address Parental Concern in Lumbar Puncture Consent: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consent
Keywords: consent
lumbar puncture
pediatric
video
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parents are randomized to either view an educational video or not
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Likert Scale for Parent Understanding, Pain perception, Safety Perception and Comfort
timeFrame: within 10 minutes of consent discussion (controls) or viewing the video (video group)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Ashutosh Singhal, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.