Lumbar Puncture Video Study

University of British Columbia

Status: Completed

Conditions: Consent

Treatments: Other: Educational Video

Study type: Interventional

Funder types: Other

Identifiers

NCT03677219

H14-00981

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Video

Experimental group

Description:

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.

Treatment:

Other: Educational Video