Bone FracturesNCT02435498
Web-based Education Module for Pain Management
A study testing Interactive website and Video in people with Bone Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Fractures
- What is being tested?
- Interactive website and Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteCanada
- Study dates
- 4 Sep 2015to 1 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital, London Health Sciences Centre
London, Ontario, N6A5W9
About this study
Official title: A Web-based Education Module Versus Standard of Care for Pain Management Following a Fracture in Children: a Randomized Controlled Trial
This study's objectives are as follows:
- 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
Read the 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.
- Conditions
- Bone Fractures
- Being tested
- Interactive website, Video, Standard of care
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive websiteOther
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
VideoOther
The online video will contain the same information within the website.
Standard of careOther
Standard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home.
| Study group | Role | What they receive |
|---|---|---|
| Interactive website | Experimental | 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 Receives: Other: Interactive website |
| Video | Active comparator | The online video will contain the same information within the website. Receives: Other: Video |
| Standard of care | Active comparator | Standard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 21-item knowledge questionnaire total score between groups
Measured: 120 hours
Secondary outcomes (6)
Number of days of work missed for parent
Measured: 120 hours
Parental confidence in recognizing pain and providing analgesia using a 5-point Likert scale
Measured: 120 hours
Number of sleep-interrupted nights for child
Measured: 120 hours
Number of days of school missed for child
Measured: 120 hours
Number of days before resumption of normal diet for child
Measured: 120 hours
Other educational resources used
Measured: 120 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study start4 Sep 2015
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveen Poonai, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Naveen Poonai, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435498
- Sponsor's protocol ID
- 106402
- Status last verified
- Apr 2017
- First submitted
- 29 Apr 2015
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-based Education Module Versus Standard of Care for Pain Management Following a Fracture in Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02435498
- Acronym / sponsor ID
- 106402
- Conditions
- Bone Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 4 Sep 2015 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 6 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study's objectives are as follows:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interactive website | Experimental | Other: Interactive websiteThe 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 comparator | Other: VideoThe online video will contain the same information within the website. |
| Standard of care | Active comparator | Other: Standard of careStandard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive websiteThe 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 | Other | Interactive website |
| VideoThe online video will contain the same information within the website. | Other | Video |
| Standard of careStandard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home. | Other | Standard of care |
Primary outcome
Change in 21-item knowledge questionnaire total score between groups
Time frame: 120 hours
6 secondary outcomes
Number of days of work missed for parent
Time frame: 120 hours
Parental confidence in recognizing pain and providing analgesia using a 5-point Likert scale
Time frame: 120 hours
Number of sleep-interrupted nights for child
Time frame: 120 hours
Number of days of school missed for child
Time frame: 120 hours
Number of days before resumption of normal diet for child
Time frame: 120 hours
Other educational resources used
Time frame: 120 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naveen Poonai, MD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive website and Video in people with Bone Fractures, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 21-item knowledge questionnaire total score between groups (time frame: 120 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017; AzTrials last refreshed its copy on 28 Oct 2026.