Lumbar Puncture Video Study

Consent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677219
• Other study ID #: H14-00981
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: May 30, 2017

Study information

• Verified date: September 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Consent

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)