- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05186844
Posttraumatic Stress Disorder in Parents and Children After Discharge From the Pediatric Intensive Care Unit (PTSD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Mamak
-
Ankara, Mamak, Turkey, 06100
- Aysegul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- All participants who do not meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
application of the post-traumatic stress disorder scale
Time Frame: on day 0-3 of discharge
|
post traumatic stress disorder scale applied to children
|
on day 0-3 of discharge
|
|
application of the post-traumatic stress disorder scale
Time Frame: on day 0-3 of discharge
|
post traumatic stress disorder scale applied to parents
|
on day 0-3 of discharge
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
application of the post-traumatic stress disorder scale
Time Frame: on day 30-40 of discharge
|
post traumatic stress disorder scale applied to children
|
on day 30-40 of discharge
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
application of the post-traumatic stress disorder scale
Time Frame: on day 30-40 of discharge
|
post traumatic stress disorder scale applied to parents
|
on day 30-40 of discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ayşegül karaca, aysegulkaraca_88@hotmail.com
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study1
- Ayfer Açıkgöz (Other Identifier: Eskisehir OU)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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