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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01471769
Other study ID # CHW 10/156
Secondary ID
Status Completed
Phase N/A
First received July 20, 2011
Last updated December 17, 2012
Start date June 2011
Est. completion date August 2012

Study information

Verified date December 2012
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 4 Years to 18 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Pain management video
6-minute video
Falls Prevention Video
6-minute video

Locations

Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in parent knowledge from baseline 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 No
Secondary Change in anxiety from baseline Parent's anxiety will be measured using a validated pain scale before and immediately after the video intervention on day 0 in the ED No
Secondary Pain medication use Pain medicatin use collected in a diary at-home after ED treatment assessed on day 0, 1, 2, 3 No
Secondary Child's pain child's reported pain at-home after ED treatment on day 0, 1, 2, 3 No
Secondary satisfaction 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 No
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