NCT01471769

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

1.2 years

First QC Date

July 20, 2011

Last Update Submit

December 17, 2012

Conditions

Keywords

pediatricpain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Change in anxiety from baseline

    on day 0 in the ED

  • Pain medication use

    assessed on day 0, 1, 2, 3

  • Child's pain

    on day 0, 1, 2, 3

  • satisfaction

    on day 1, 2, and 3

Study Arms (2)

pain management video

EXPERIMENTAL

Experimental

Behavioral: Pain management video

falls prevention video

PLACEBO COMPARATOR

placebo

Behavioral: Falls Prevention Video

Interventions

6-minute video

pain management video

6-minute video

Also known as: Fall Prevention Video
falls prevention video

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • complaint of pain or injury and laceration, fracture or spring, contusion, crush injuries, head injury, motor vehicle collision, or burn.

You may not qualify if:

  • non- English speaking parents
  • primary caregiver not with child in Emergency Department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amy L Drendel, DO

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator: Assistant Professor, DO, MS

Study Record Dates

First Submitted

July 20, 2011

First Posted

November 16, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations