Web-based Education Module for Pain Management
A Web-based Education Module Versus Standard of Care for Pain Management Following a Fracture in Children: a Randomized Controlled Trial
1 other identifier
interventional
311
1 country
1
Brief Summary
This study's objectives are as follows: 1\. To evaluate the utility of a website to provide information and guidance about pain management in children 2. To educate parents about the pathophysiology of pain, proper use of analgesic medications and signs of pain in children 3. To reduce the functional impact of pain in children following treatment for fracture 4. To endow parents with confidence to manage their child's pain at home 5. To dispel misconceptions about the use and safety of analgesics in children 6. To increase awareness of complications of fractures such as compartment syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
May 6, 2015
CompletedStudy Start
First participant enrolled
September 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 21, 2017
April 1, 2017
1.6 years
April 29, 2015
April 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in 21-item knowledge questionnaire total score between groups
120 hours
Secondary Outcomes (6)
Number of days of work missed for parent
120 hours
Parental confidence in recognizing pain and providing analgesia using a 5-point Likert scale
120 hours
Number of sleep-interrupted nights for child
120 hours
Number of days of school missed for child
120 hours
Number of days before resumption of normal diet for child
120 hours
- +1 more secondary outcomes
Study Arms (3)
Interactive website
EXPERIMENTALThe interactive website called Online User Centered Home Pain Management for Fractures (OUCH PMF) will cover 4 domains of knowledge: 1. Fracture-related pain 2. Analgesic dosing regimens 3. Indications, risks and safety of analgesia in children 4. Signs and symptoms of pain in children
Video
ACTIVE COMPARATORThe online video will contain the same information within the website.
Standard of care
ACTIVE COMPARATORStandard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home.
Interventions
The interactive website called Online User Centered Home Pain Management for Fractures (OUCH PMF) will cover 4 domains of knowledge: 1. Fracture-related pain 2. Analgesic dosing regimens 3. Indications, risks and safety of analgesia in children 4. Signs and symptoms of pain in children
Standard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home.
Eligibility Criteria
You may qualify if:
- All caregivers who are in attendance with their child (any age) for a primary complaint of a non-operative fracture managed by the paediatric emergency physician AND will be the primary caregiver for the child at home.
You may not qualify if:
- Poor parental English fluency
- Lack of a home computer with Internet access
- Child with a history of renal disease, liver disease, bleeding diathesis, chronic pain issues, or pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital, London Health Sciences Centre
London, Ontario, N6A5W9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naveen Poonai, MD
Western University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 29, 2015
First Posted
May 6, 2015
Study Start
September 4, 2015
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
April 21, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share