BurnsNCT03838172
Investigation of the Impact of Burn Injury on Parents
An observational study of Burns and Parents, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Family impact scale
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2019to 1 May 2021
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents who have a burned child
Who may be able to join
- Parents who have a burned child
- Parents who have a volunteer
Who cannot join
- Parents who have no confirm to participate this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Family impact scale
- Keywords
- Burn Injury, quality of life, scar
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family impact scaleOther
The family Impact Scale (FIS) will be completed by the parents
| Study group | Role | What they receive |
|---|---|---|
| Parents | Parents who have a burned child Receives: Other: Family impact scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family of Impact scale
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.
Measured: 15 minutes
Secondary outcomes (4)
Nottingham Health Profile
Nottingham Health Profile is a widely used measure of perceived health status. The higher score is indicated the lower quality of life.
Measured: 15 minutes
The hospital anxiety and depression scale
It is a self-reported questionnaire that measures level of anxiety and depression. the higher score is indicated the higher anxiety level.
Measured: 15 minutes
The Spielberger State-Trait Anxiety Inventory
It is used to determine anxiety level of parents. Higher scores are an indication of greater anxiety.
Measured: 15 minutes
Patient and Observer Scar Assessment Scale
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
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start20 Feb 2019
- Primary completion30 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozden Ozkal, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838172
- Sponsor's protocol ID
- GO 19/28
- Status last verified
- Aug 2021
- First submitted
- 10 Feb 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Burn Injury on Parents
- ClinicalTrials.gov ID
- NCT03838172
- Acronym / sponsor ID
- GO 19/28
- Keywords
- Burn Injury, quality of life, scar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 12 Feb 2019 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents | – | Other: Family impact scaleParents who have a burned child |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents who have a burned child
Key inclusion criteria (2 listed)
- Parents who have a burned child
- Parents who have a volunteer
Key exclusion criteria (1 listed)
- Parents who have no confirm to participate this study
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 |
|---|---|---|
| Family impact scaleThe family Impact Scale (FIS) will be completed by the parents | Other | Parents |
Primary outcome
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.
4 secondary outcomes
Nottingham Health Profile
Time frame: 15 minutes
The hospital anxiety and depression scale
Time frame: 15 minutes
The Spielberger State-Trait Anxiety Inventory
Time frame: 15 minutes
Patient and Observer Scar Assessment Scale
Time frame: 15 minutes
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 25 Aug 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns and Parents, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 25 Aug 2021. 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 Turkey (Türkiye). 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?
Family of Impact scale (time frame: 15 minutes). 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 25 Aug 2021.