NCT05186844

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

October 15, 2021

Last Update Submit

December 23, 2021

Conditions

Keywords

child, intensive care, parent, PTSD

Outcome Measures

Primary Outcomes (2)

  • application of the post-traumatic stress disorder scale

    post traumatic stress disorder scale applied to children

    on day 0-3 of discharge

  • application of the post-traumatic stress disorder scale

    post traumatic stress disorder scale applied to parents

    on day 0-3 of discharge

Secondary Outcomes (1)

  • application of the post-traumatic stress disorder scale

    on day 30-40 of discharge

Other Outcomes (1)

  • application of the post-traumatic stress disorder scale

    on day 30-40 of discharge

Interventions

Scales and questionnaires were applied to children and their parents according to age groups.

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aysegul

Ankara, Mamak, 06100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The research was conducted as a survey study only.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • ayşegül karaca

    aysegulkaraca_88@hotmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

October 15, 2021

First Posted

January 11, 2022

Study Start

January 1, 2019

Primary Completion

March 1, 2019

Study Completion

January 20, 2020

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Cannot be shared because it is in the publishing phase.

Locations