NCT06275711

Brief Summary

Earthquake is a disaster that causes physical, psychological, social, economic and cultural losses for individuals and affects/interrupts all age groups and normal life. Children are a group that is more affected by the earthquake than other members of the society and are exposed to its long-term effects. Children who have experienced earthquakes and continue to stay in the earthquake zone experience physical, economic, and social problems. In addition, the emotional and psychological development of these children is negatively affected. Due to the earthquake that occurred on 6 February 2023 affecting 11 provinces in our country, the needs in the field vary. After the acute period (first 1 month), children need psychological support. Problems that cannot be solved in the early period may cause health and behavioural problems in children in later ages and adulthood. In this context, approaching children with appropriate therapeutic communication methods positively affects their psychological well-being and directly affected physical resilience by enabling them to express their emotions. The aim of the study was to evaluate the effect of therapeutic communication programme on state and trait anxiety levels, psychological resilience, mental health and well-being of children aged 8-12 years affected by the earthquake. Hypotheses H1. After the therapeutic communication programme, children's State Anxiety Scale scores decrease. H2. After the therapeutic communication programme, children's Continuance Anxiety Scale scores decrease. H3. After the therapeutic communication programme, children's Me and My Emotions Scale scores decrease. H4. After the therapeutic communication programme, children's scores on the Child and Adolescent Psychological Resilience Scale increase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

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

November 30, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
Last Updated

October 2, 2024

Status Verified

October 1, 2024

Enrollment Period

6 days

First QC Date

February 5, 2024

Last Update Submit

October 1, 2024

Conditions

Keywords

childrenearthquakeanxietyaffectionpsychological resilience

Outcome Measures

Primary Outcomes (4)

  • State Anxiety Scale on Children

    The score to be obtained from the trait anxiety subsection of the inventory varies between 20-60. The higher the score obtained from the inventory, the higher the level of anxiety.

    before the study is started (day 1) / after the study is completed (day 7)

  • Trait Anxiety Scale on Children

    The score to be obtained from the trait anxiety subsection of the inventory varies between 20-60. The higher the score obtained from the inventory, the higher the level of anxiety.

    before the study is started (day 1) / after the study is completed (day 7)

  • Me and My Feelings Scale on Children

    The score range for emotional difficulties and behavioural difficulties is 0-20 and 0-12, respectively.

    before the study is started (day 1) / after the study is completed (day 7)

  • Child and Youth Resilience Measure

    High scores obtained from the scale indicate a high level of psychological resilience. There is no cut-off value.

    before the study is started (day 1) / after the study is completed (day 7)

Study Arms (1)

Therapeutic communication

EXPERIMENTAL

Therapeutic communication methods were applied. Pre-test and post-test measurements were made

Behavioral: Therapeutic communication methods

Interventions

Drawing pictures, story completion, breathing and relaxation exercises

Therapeutic communication

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • He is willing to participate in the programme,
  • Children aged 8-12 years (verbal consent will be obtained from children and written consent will be obtained from their parents).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

K-1 Container City

Adıyaman, Altınsehir, 02040, Turkey (Türkiye)

Location

Related Publications (2)

  • Blanc J, Eugene D, Louis EF, Cadichon JM, Joseph J, Pierre A, Laine R, Alexandre M, Huang KY. Mental Health Among Children Older than 10 Years Exposed to the Haiti 2010 Earthquake: a Critical Review. Curr Psychiatry Rep. 2020 Sep 2;22(11):57. doi: 10.1007/s11920-020-01178-9.

    PMID: 32876808BACKGROUND
  • Sever MS, Sever L, Vanholder R. Disasters, children and the kidneys. Pediatr Nephrol. 2020 Aug;35(8):1381-1393. doi: 10.1007/s00467-019-04310-x. Epub 2019 Aug 17.

    PMID: 31422466BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Gizem Cakir, PhD(c)

    Gazi University Nursing Faculty

    PRINCIPAL INVESTIGATOR
  • Rukiye Celik, PhD(c)

    Gazi University Nursing Faculty

    PRINCIPAL INVESTIGATOR
  • Naime Altay, PhD

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Pre-test post-test quasi-experimental study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 23, 2024

Study Start

November 30, 2023

Primary Completion

December 6, 2023

Study Completion

December 6, 2023

Last Updated

October 2, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations