NCT05815966

Brief Summary

Earthquakes cause increased mental health problems in the communities they hit. Few attempts have been made to develop effective psychological care strategies for earthquake survivors. Interventions are needed to deal with traumatic stress issues in large populations that survive devastating earthquakes. Fear and anxiety post-traumatic growth and rumination can coexist in individuals after traumatic experiences, and the cognitive pathways leading to them may be different. However, to date, no study has examined the effect of emotion recognition and empathy focused education program on anxiety, rumination and post-traumatic growth levels. This situation constitutes the original value of this project. The aim of this project is to investigate the effect of the emotion recognition and empathy-oriented education program applied to earthquake survivors on children's anxiety, rumination and post-traumatic growth levels. The data of this project, which is planned in accordance with the experimental research principles, will be collected in two primary schools planned to be opened after 13 March 2023. Demographic information form, Event-Related Rumination Inventory, Post-Traumatic Growth Inventory, and Child Anxiety Scale-State and Child Fear Inventory will be used as the project data collection form. The results obtained in this project are planned to be presented as an oral presentation at a national or international congress that will take place in 2023 or 2024 with the theme of child health, nursing or disaster nursing. The data of the research will be evaluated with the SPSS 20.0 program on the computer. Percentage, mean and t test will be used in the analysis of the data. Chi-square test, Sperman correlation and Wilcoxon test will be used for categorical comparisons. The significance level will be accepted as 0.05 in all statistical processes used within the scope of the research. The significance level will be accepted as 0.05 in all statistical processes used within the scope of the research.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable anxiety

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

April 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

March 30, 2023

Last Update Submit

April 14, 2023

Conditions

Keywords

Anxietyearthquakefearruminationgrowth after trauma

Outcome Measures

Primary Outcomes (4)

  • the Event Related Rumination Inventory

    This scale was developed to measure intrusive and voluntary ruminations after traumatic events and consists of 20 items in total for both types of rumination. In the first part of the scale, there are 10 questions in which participants are asked to indicate how much the event occupied them, even though they try not to think about the traumatic experience, and these questions measure the level of intrusive rumination. The questions in the second part, on the other hand, determine the level of voluntary rumination through the answers given to how much thought of the event, especially and intentionally, after the traumatic experience. The scale is scored as a 4-point Likert scale. In the validity and reliability study of the scale, it is stated that the internal consistency scores are strong and explain 57% of the variance.A minimum of 0 points and a maximum of 60 points are taken from the scale.A high score on the scale indicates that repetitive thoughts about the event increase.

    Change in rumination at 5 weeks

  • Child Anxiety Scale-State Scale

    It is similar to a thermometer with a light bulb at the bottom and horizontal lines at intervals that go up. This scale, for children aged 4-10, is instructed to "Imagine all anxious or angry feelings are at the bottom here (point to the scale)". If you're a little worried or nervous, the emotions may be a little heightened (put your finger up). If you are very, very anxious or nervous, the emotions may run high (move your finger to the top). The use of the scale is explained as "Put a line showing how anxious or angry you feel". To measure the child's state anxiety, the child is asked to mark what he feels "at the moment". Before the children fill out the ÇAS-D scale, the child's sequencing ability is monitored. A transparent meter is placed above the child's rating with 0.5 point increments marked, then 0.5 point increments are rounded up to the nearest number. The score can vary between 0-10.

    Change in anxiety at 5 weeks

  • Child Fear Scale

    It is used to measure the child's fear level. The CDS is a scale of 0-4, consisting of showing five drawn facial expressions ranging from neutral (0=no fear) to frightened face (4=severe fear). The fear experienced by the child before, during and after the procedure can be used in the evaluation by parents or researchers. The scale is intended for children aged 5-10 years.

    Change in fear at 5 weeks

  • Post Traumatic Growth Scale

    This 21-item scale was developed by Tedeschi and Calhoun (1996) to evaluate the positive development/transformations that can be seen in individuals after traumatic experiences. This scale was translated into Turkish by Dirik (2006) considering the Kılıç (2005) translation. In this study, it was used to evaluate the positive transformations that may occur after trauma and to investigate the factors that contribute to positive results. Using the translation of Dirik (2006) and the 5-factor structure.Posttraumatic growth (PTG) total score (Mean = 2.81, SD = 1.23, Min = 0, Max = 5, Range = 5) was calculated by summing the responses to 21 items and dividing by the number of items. A high mean score indicates greater development after a traumatic experience.

    Change in post traumatic growth at 5 weeks

Study Arms (2)

Experimental: emotion recognition and empathy focused training program

EXPERIMENTAL

A suitable hall for children will be determined by the school administration. Education days and hours for the children in the experimental group will be determined by negotiating with the 4th grade teachers. In this study, a 50-minute training program consisting of 2 sessions per week, lasting 5 weeks, will be applied to the experimental group.

Behavioral: The effect of emotion recognition and empathy focused education program

Control group

NO INTERVENTION

Standard care group

Interventions

Emotion recognition and empathy-oriented education program is a group-based, interactive program that includes techniques such as vision development, brainstorming, painting and drawing, recital, role-playing, gamification and information notes, which requires the active participation of children. Within the program; There are trainings aimed at establishing bilateral relations, gaining in-group commitment, expressing emotions comfortably, feeling that they are not alone, and learning new resources that will make them feel good when they feel bad. The aims of education; children,

Experimental: emotion recognition and empathy focused training program

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being able to speak and understand Turkish,
  • The children and their parents have voluntarily given their consent to the research,
  • Absence of physical or mental disability,
  • Having experienced the February 6 earthquake,

You may not qualify if:

  • Existence of physical and mental disability,
  • Having a diagnosis of neurological disease,
  • Lack of attention,
  • Not attending 1 session,
  • Failure to fill one of the scales applied in the tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Xu J, Xie L, Li B, Li N, Yang Y. Anxiety symptoms among children after the Wenchuan earthquake in China. Nord J Psychiatry. 2012 Oct;66(5):349-54. doi: 10.3109/08039488.2011.650197. Epub 2012 Jan 30.

    PMID: 22283715BACKGROUND
  • Dutta A, Pena F, Holcomb JM, Leiva L, Squicciarini AM, Canenguez KM, Bergmann P, Riobueno-Naylor A, Farley AM, Simonsohn A, Garfin DR, Cohen Silver R, Benheim TS, Guzman J, Jellinek MS, Murphy JM. Earthquake exposure, adverse childhood experiences, and psychosocial functioning in Chilean children: A longitudinal study. J Trauma Stress. 2022 Aug;35(4):1177-1188. doi: 10.1002/jts.22826. Epub 2022 Mar 30.

    PMID: 35355336BACKGROUND
  • Forresi B, Caputi M, Scaini S, Caffo E, Aggazzotti G, Righi E. Parental Internalizing Psychopathology and PTSD in Offspring after the 2012 Earthquake in Italy. Children (Basel). 2021 Oct 17;8(10):930. doi: 10.3390/children8100930.

    PMID: 34682196BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersRumination Syndrome

Condition Hierarchy (Ancestors)

Mental DisordersGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating Disorders

Study Officials

  • Ayşe Elkoca

    Gaziantep Islam Science and Technology University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist.Prof.Dr. Ayşe Elkoca

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 18, 2023

Study Start

April 30, 2023

Primary Completion

June 30, 2023

Study Completion

October 30, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share