Clinical trial NCT02435498: Web-based Education Module for Pain Management
Official title: A Web-based Education Module Versus Standard of Care for Pain Management Following a Fracture in Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Fractures
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-05-06
Enrollment: 311
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: This study will compare the effectiveness of three mediums of parental education among parents of children treated for non-operative fractures in the emergency department (ED): 1) A novel website entitled, "Online User-Centered Home Pain Management for Fractures" (OUCH PMF) 2) An online educational video (OV) and 3) standard discharge instructions (SOC). The investigators primary goal is to see which modality results in a greater improvement in scores on a on a knowledge questionnaire. The investigators secondary goals are to see which modality results in better parental satisfaction, confidence in managing pain, and lower impact of injury on the child and family. As participants will receive the standard-of-care that includes a pamphlet on how to take care of the cast. During their stay in the ED, participants will be randomly assigned to one of the three aforementioned groups. Participants will then be given the pre-intervention knowledge questionnaire, followed by the intervention and then the post-intervention knowledge questionnaire, prior to being discharged. At 120 hours post-discharge, participants will be asked to access an online survey to obtain information about the functional impact of the injury on their child. The investigators goal is to compare online and video education tools in their ability to improve parental knowledge, confidence, and satisfaction regarding the treatment of fracture pain.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in 21-item knowledge questionnaire total score between groups
timeFrame: 120 hours
Secondary outcomes:
measure: Number of days of work missed for parent
timeFrame: 120 hours
measure: Parental confidence in recognizing pain and providing analgesia using a 5-point Likert scale
timeFrame: 120 hours
measure: Number of sleep-interrupted nights for child
timeFrame: 120 hours
measure: Number of days of school missed for child
timeFrame: 120 hours
measure: Number of days before resumption of normal diet for child
timeFrame: 120 hours
measure: Other educational resources used
timeFrame: 120 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: Children's Hospital, London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University
name: Naveen Poonai, MD
role: PRINCIPAL_INVESTIGATOR
References: