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Web-based Education Module for Pain Management

Primary Purpose

Bone Fractures

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Interactive website
Video
Standard of care
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bone Fractures

Eligibility Criteria

undefined - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's Hospital, London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Interactive website

Video

Standard of care

Arm Description

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

The online video will contain the same information within the website.

Standard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home.

Outcomes

Primary Outcome Measures

Change in 21-item knowledge questionnaire total score between groups

Secondary Outcome Measures

Number of days of work missed for parent
Parental confidence in recognizing pain and providing analgesia using a 5-point Likert scale
Number of sleep-interrupted nights for child
Number of days of school missed for child
Number of days before resumption of normal diet for child
Other educational resources used

Full Information

First Posted
April 29, 2015
Last Updated
April 19, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02435498
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 4, 2015 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Fractures

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
311 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interactive website
Arm Type
Experimental
Arm Description
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
Arm Title
Video
Arm Type
Active Comparator
Arm Description
The online video will contain the same information within the website.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Standard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home.
Intervention Type
Other
Intervention Name(s)
Interactive website
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Video
Intervention Description
The online video will contain the same information within the website.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Standard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home.
Primary Outcome Measure Information:
Title
Change in 21-item knowledge questionnaire total score between groups
Time Frame
120 hours
Secondary Outcome Measure Information:
Title
Number of days of work missed for parent
Time Frame
120 hours
Title
Parental confidence in recognizing pain and providing analgesia using a 5-point Likert scale
Time Frame
120 hours
Title
Number of sleep-interrupted nights for child
Time Frame
120 hours
Title
Number of days of school missed for child
Time Frame
120 hours
Title
Number of days before resumption of normal diet for child
Time Frame
120 hours
Title
Other educational resources used
Time Frame
120 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naveen Poonai, MD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5W9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Web-based Education Module for Pain Management

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