Posttraumatic Stress DisorderPTSDNCT05186844
Posttraumatic Stress Disorder in Parents and Children After Discharge From the Pediatric Intensive Care Unit
An observational study of Posttraumatic Stress Disorder and Parents, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Background: If disorders that occur immediately after a trauma are not treated, they may become chronic and turn into severe health problems. Objectives: This study was conducted with children who had spent time in an intensive care unit and their parents to examine the development of posttraumatic stress disorder… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Parents, Children, Only
- What is being tested?
- survey application
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 20 Jan 2020
- How long will I take part?
- 3 Months
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: In the power analysis conducted using the G*power 3.0.10 program and an alpha=0.05 margin of error, the power of the study was 85% for 110 children, 93.3% for the 98 mothers and 81.5% for the 80 fathers.
Who may be able to join
- The child was between 8-12 years old,
- The child had an accompanying adult present,
- The child was conscious and/or able to communicate verbally,
- The child did not have any intellectual disability,
- There were no challenges in communicating with the family and/or the child (i.e., they spoke Turkish, were able to communicate),
- The child's stay at the PICU was no longer than 29 days,
- The child and their family volunteered to participate in the study.
Who cannot join
- All participants who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Background: If disorders that occur immediately after a trauma are not treated, they may become chronic and turn into severe health problems.
Objectives: This study was conducted with children who had spent time in an intensive care unit and their parents to examine the development of posttraumatic stress disorder (PTSD) in both children and parents.
Methods: The study was a cross-sectional study. A total of 110 children, 98 mothers and 80 fathers were included in the study.
Read the detailed description
Background: If disorders that occur immediately after a trauma are not treated, they may become chronic and turn into severe health problems.
Objectives: This study was conducted with children who had spent time in an intensive care unit and their parents to examine the development of posttraumatic stress disorder (PTSD) in both children and parents.
Methods: The research was carried out in the intensive care unit of a children's hospital in Turkey. Children between the ages of 8-12 who had spent time in the PICU over the period January 1 - March 1, 2019, who had been discharged from the PICU or transferred into another unit during this time, and who met the research criteria were included in the study. Between these dates, the total number of children discharged from intensive care or transferred into another unit was 166. Of these children, 138 were between the ages of 8-12. During this period, three children who died, two children whose general condition meant they were unable to participate in the study, and 23 children for whom parental consent could not be obtained were excluded from the study. The study was ultimately completed with 110 children. In addition, the parents of the children in the sample group (98 mothers and 80 fathers) who were alive, reachable, and who agreed to participate were included in the study.
Results: A total of 110 children, 98 mothers and 80 fathers who agreed to participate in the study, met the sample selection criteria, and were available throughout were included in the study.
- Conditions
- Posttraumatic Stress Disorder, Parents, Children, Only
- Being tested
- survey application
- Keywords
- child, intensive care, parent, PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey applicationBehavioural
Scales and questionnaires were applied to children and their parents according to age groups.
What is being measured
The primary outcome is the main question the study is designed to answer.
application of the post-traumatic stress disorder scale
post traumatic stress disorder scale applied to children
Measured: on day 0-3 of discharge
application of the post-traumatic stress disorder scale
post traumatic stress disorder scale applied to parents
Measured: on day 0-3 of discharge
Secondary outcomes (1)
application of the post-traumatic stress disorder scale
post traumatic stress disorder scale applied to children
Measured: on day 30-40 of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start1 Jan 2019
- Primary completion1 Mar 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül Karaca, Eskisehir Osmangazi University
- Investigators
- ayşegül karaca, Principal investigator, aysegulkaraca_88@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186844
- Sponsor's protocol ID
- Study1
- Other IDs
- Ayfer Açıkgöz
- Acronym
- PTSD
- Status last verified
- Dec 2021
- First submitted
- 15 Oct 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Cannot be shared because it is in the publishing phase.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posttraumatic Stress Disorder in Parents and Children After Discharge From the Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05186844
- Acronym / sponsor ID
- PTSD / Study1
- Conditions
- Posttraumatic Stress Disorder, Parents, Children, Only
- Keywords
- child, intensive care, parent, PTSD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 11 Jan 2022 (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.
Background: If disorders that occur immediately after a trauma are not treated, they may become chronic and turn into severe health problems.
Objectives: This study was conducted with children who had spent time in an intensive care unit and their parents to examine the development of posttraumatic stress disorder (PTSD) in both children and parents.
Methods: The study was a cross-sectional study. A total of 110 children, 98 mothers and 80 fathers were included in the study.
Detailed description
Background: If disorders that occur immediately after a trauma are not treated, they may become chronic and turn into severe health problems.
Objectives: This study was conducted with children who had spent time in an intensive care unit and their parents to examine the development of posttraumatic stress disorder (PTSD) in both children and parents.
Methods: The research was carried out in the intensive care unit of a children's hospital in Turkey. Children between the ages of 8-12 who had spent time in the PICU over the period January 1 - March 1, 2019, who had been discharged from the PICU or transferred into another unit during this time, and who met the research criteria were included in the study. Between these dates, the total number of children discharged from intensive care or transferred into another unit was 166. Of these children, 138 were between the ages of 8-12. During this period, three children who died, two children whose general condition meant they were unable to participate in the study, and 23 children for whom parental consent could not be obtained were excluded from the study. The study was ultimately completed with 110 children. In addition, the parents of the children in the sample group (98 mothers and 80 fathers) who were alive, reachable, and who agreed to participate were included in the study.
Results: A total of 110 children, 98 mothers and 80 fathers who agreed to participate in the study, met the sample selection criteria, and were available throughout were included in the study.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- In the power analysis conducted using the G*power 3.0.10 program and an alpha=0.05 margin of error, the power of the study was 85% for 110 children, 93.3% for the 98 mothers and 81.5% for the 80 fathers.
Key inclusion criteria (7 listed)
- The child was between 8-12 years old,
- The child had an accompanying adult present,
- The child was conscious and/or able to communicate verbally,
- The child did not have any intellectual disability,
- There were no challenges in communicating with the family and/or the child (i.e., they spoke Turkish, were able to communicate),
Key exclusion criteria (1 listed)
- All participants who do not meet the inclusion criteria
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 |
|---|---|---|
| survey applicationScales and questionnaires were applied to children and their parents according to age groups. | Behavioural | – |
Primary outcome
application of the post-traumatic stress disorder scale
Time frame: on day 0-3 of discharge
post traumatic stress disorder scale applied to children
application of the post-traumatic stress disorder scale
Time frame: on day 0-3 of discharge
post traumatic stress disorder scale applied to parents
1 secondary outcome
application of the post-traumatic stress disorder scale
Time frame: on day 30-40 of discharge
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 11 Jan 2022.
- Individual participant dataSharing planned: No. Cannot be shared because it is in the publishing phase.
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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.
ayşegül karaca principal investigator
aysegulkaraca_88@hotmail.com
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 Posttraumatic Stress Disorder and Parents, run by Eskisehir Osmangazi 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 7 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 11 Jan 2022. 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?
application of the post-traumatic stress disorder scale (time frame: on day 0-3 of discharge). The study lists 2 primary outcomes in all. 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 11 Jan 2022.