- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03838172
Investigation of the Impact of Burn Injury on Parents
August 24, 2021 updated by: Ozden Ozkal, Hacettepe University
The Effects of Burn Injury on Parents
Burn injuries are related to longer hospital stay.
Patients who have a burned child are affected prolonged hospitalization.
Social life and quality of life are affected by burn injuries.
Therefore, the aim of this study is to investigate the effects of burn injury on parents.
Study Overview
Detailed Description
Pediatric burn injuries is commonly seen.
Burn injuries are extended from minor injuries to severe injuries.
The severity of burn injury may affect burn related complications such as scar tissue and duration of hospitalization.
This process extremely affect parents.
Although parents are part of this prolonged treatments process, there is no study that evaluated of the impact of burn injury on parents.
Therefore, the aim of this study is to investigate the effects of burn injury on parents.
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06100
- Ozden Ozkal
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Parents who have a burned child
Description
Inclusion Criteria:
- Parents who have a burned child
- Parents who have a volunteer
Exclusion Criteria:
- Parents who have no confirm to participate this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Parents
Parents who have a burned child
|
The family Impact Scale (FIS) will be completed by the parents
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Family of Impact scale
Time Frame: 15 minutes
|
questionnaire is a self-report instrument designed to measure the effects of childhood diseased on parents.
A low score indicates a higher impact of the disease on the parents.
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nottingham Health Profile
Time Frame: 15 minutes
|
Nottingham Health Profile is a widely used measure of perceived health status.
The higher score is indicated the lower quality of life.
|
15 minutes
|
|
The hospital anxiety and depression scale
Time Frame: 15 minutes
|
It is a self-reported questionnaire that measures level of anxiety and depression.
the higher score is indicated the higher anxiety level.
|
15 minutes
|
|
The Spielberger State-Trait Anxiety Inventory
Time Frame: 15 minutes
|
It is used to determine anxiety level of parents.
Higher scores are an indication of greater anxiety.
|
15 minutes
|
|
Patient and Observer Scar Assessment Scale
Time Frame: 15 minutes
|
The Patient and Observer Scar Assessment Scale consists of two scales, the patient scale, which contains six items, and the observer scale, which contains five items.
The higher score indicates the greater scar tissue
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 20, 2019
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
May 1, 2021
Study Registration Dates
First Submitted
February 10, 2019
First Submitted That Met QC Criteria
February 10, 2019
First Posted (Actual)
February 12, 2019
Study Record Updates
Last Update Posted (Actual)
August 25, 2021
Last Update Submitted That Met QC Criteria
August 24, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 19/28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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