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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05186844
Other study ID # Study1
Secondary ID Ayfer Açikgöz
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date January 20, 2020

Study information

Verified date December 2021
Source Eskisehir Osmangazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 (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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date January 20, 2020
Est. primary completion date March 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility 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 Design


Intervention

Behavioral:
survey application
Scales and questionnaires were applied to children and their parents according to age groups.

Locations

Country Name City State
Turkey Aysegul Ankara Mamak

Sponsors (1)

Lead Sponsor Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other application of the post-traumatic stress disorder scale post traumatic stress disorder scale applied to parents on day 30-40 of discharge
Primary application of the post-traumatic stress disorder scale post traumatic stress disorder scale applied to children on day 0-3 of discharge
Primary application of the post-traumatic stress disorder scale post traumatic stress disorder scale applied to parents on day 0-3 of discharge
Secondary application of the post-traumatic stress disorder scale post traumatic stress disorder scale applied to children on day 30-40 of discharge
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