Web-based Education Module for Pain Management

NCT ID: NCT02435498

Last Updated: 2017-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-04

Study Completion Date

2017-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bone Fractures

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Interactive website

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Video

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Video

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

Intervention Type OTHER

Standard of care

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Naveen Poonai

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Naveen Poonai, MD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's Hospital, London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

106402

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.