Consent
Conditions
Keywords
consent, lumbar puncture, pediatric, video
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.
Interventions
OTHEREducational Video
The educational video is a 2 minute video depicting a live lumbar puncture on an infant interwoven with animations of the relevant anatomy.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Intervention model description
Parents are randomized to either view an educational video or not
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Likert Scale for Parent Understanding, Pain perception, Safety Perception and Comfort | 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. |
Outcome results
None listed