- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01471769
Video Education Intervention in the Emergency Department
December 17, 2012 updated by: Amy Drendel, Medical College of Wisconsin
The purpose of this study is to evaluate if an educational video viewed during the Emergency Department visit will improve parent knowledge of pain management, reduce parent anxiety, and change their use of analgesics at-home after discharge from the Emergency Department.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will investigate the use of a video instruction for parents just prior to discharge on pain treatment for their child.
The investigators plan to investigate the effect of the video on knowledge because educational modules in the form of videotapes have been shown to be an effective method to improve a parent's knowledge about pain management prior to surgical procedures.
Because parental anxiety has a significant impact on a child's experience of pain and video education has been shown to reduce parent anxiety before a procedure, the investigators will also evaluate if parental anxiety is reduced.
Whether or not a short video will change the behavior of parents or their satisfaction with the outcome at home has not been investigated and will be an exploratory hypothesis for this study.
This research will be a first step towards optimizing the outpatient care for common diagnoses in the Emergency Department.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53201
- Children's Hospital of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- complaint of pain or injury and laceration, fracture or spring, contusion, crush injuries, head injury, motor vehicle collision, or burn.
Exclusion Criteria:
- non- English speaking parents
- primary caregiver not with child in Emergency Department
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: pain management video
Experimental
|
6-minute video
|
|
PLACEBO_COMPARATOR: falls prevention video
placebo
|
6-minute video
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in parent knowledge from baseline
Time Frame: on day 0 in the ED
|
A parent knowledge test will be completed by parents prior to the video intervention, immediately after the video intervention, and on day 3 after the video intervention.
|
on day 0 in the ED
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in anxiety from baseline
Time Frame: on day 0 in the ED
|
Parent's anxiety will be measured using a validated pain scale before and immediately after the video intervention
|
on day 0 in the ED
|
|
Pain medication use
Time Frame: assessed on day 0, 1, 2, 3
|
Pain medicatin use collected in a diary at-home after ED treatment
|
assessed on day 0, 1, 2, 3
|
|
Child's pain
Time Frame: on day 0, 1, 2, 3
|
child's reported pain at-home after ED treatment
|
on day 0, 1, 2, 3
|
|
satisfaction
Time Frame: on day 1, 2, and 3
|
child and parent at-home satisfaction utilizing a validated likert scale will be assesed on day 1, 2, and 3 after ED treatment to determine if the intervention results in improved satisfaction with pain treatment after discharge home
|
on day 1, 2, and 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (ACTUAL)
August 1, 2012
Study Completion (ACTUAL)
August 1, 2012
Study Registration Dates
First Submitted
July 20, 2011
First Submitted That Met QC Criteria
November 10, 2011
First Posted (ESTIMATE)
November 16, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
December 19, 2012
Last Update Submitted That Met QC Criteria
December 17, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHW 10/156
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.
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