Web-based Education Module for Pain Management

Bone Fractures Clinical Trial

Official title:

A Web-based Education Module Versus Standard of Care for Pain Management Following a Fracture in Children: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435498
• Other study ID #: 106402
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: April 19, 2017
• Start date: September 4, 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: April 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Fractures
• Fractures, Bone

Intervention

Other:
• Interactive website
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
• Video
The online video will contain the same information within the website.
• Standard of care
Standard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home.

Locations

Country	Name	City	State
Canada	Children's Hospital, London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 21-item knowledge questionnaire total score between groups		120 hours
Secondary	Number of days of work missed for parent		120 hours
Secondary	Parental confidence in recognizing pain and providing analgesia using a 5-point Likert scale		120 hours
Secondary	Number of sleep-interrupted nights for child		120 hours
Secondary	Number of days of school missed for child		120 hours
Secondary	Number of days before resumption of normal diet for child		120 hours
Secondary	Other educational resources used		120 hours