- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03677219
Lumbar Puncture Video Study
An Educational Video to Address Parental Concern in Lumbar Puncture Consent: A Randomized Control Trial
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 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.
|
|
Experimental: 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.
|
The educational video is a 2 minute video depicting a live lumbar puncture on an infant interwoven with animations of the relevant anatomy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Likert Scale for Parent Understanding, Pain perception, Safety Perception and Comfort
Time Frame: 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.
|
within 10 minutes of consent discussion (controls) or viewing the video (video group)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ashutosh Singhal, MD MSc, University of British Columbia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H14-00981
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Consent
-
University of ChicagoRecruitingAnesthesia | Patient Satisfaction | Anesthesia Risks | Anesthesia Consent | Consent RetentionUnited States
-
The University of Texas Health Science Center,...CompletedUnderstanding of Consent in Clinical Research | Implementation of Consent in Clinical ResearchUnited States
-
Weill Medical College of Cornell UniversityCompletedTablet-delivered Informed Consent | Paper-based Informed ConsentUnited States
-
US Department of Veterans AffairsCompleted
-
Wake Forest University Health SciencesNational Center for Advancing Translational Sciences (NCATS)Completed
-
National Cancer Institute (NCI)CompletedEmotions | Informed ConsentUnited States
-
Brooke Army Medical CenterCompletedHysterectomy | Informed ConsentUnited States
-
US Department of Veterans AffairsCompleted
-
The Hospital for Sick ChildrenActive, not recruiting
Clinical Trials on Educational Video
-
Drexel UniversityCompletedOther Surgical Procedures
-
St. Joseph's Healthcare HamiltonNot yet recruitingBody Image | Eating, Healthy
-
Black Hills State UniversityNational Institute of General Medical Sciences (NIGMS)Recruiting
-
Elizabeth MuellerCompletedPelvic Floor Disorders | Patient ComplianceUnited States
-
University of California, IrvineKaiser PermanenteUnknownStress Urinary Incontinence | Knowledge, Attitudes, PracticeUnited States
-
University of Illinois at ChicagoActive, not recruiting
-
George Washington UniversityCompletedHuman Papilloma Virus | Cervical DysplasiaUnited States
-
Sun Yat-sen UniversityWenzhou Medical UniversitySuspended
-
University of PittsburghCompleted