Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Sample of the Research However, since children affected by the earthquake need psychological support, all children who are willing to participate in the programme will be included in order to provide the highest benefit. People who meet the research criteria and volunteer to participate in the research will be selected. In order to determine the power of the research, post-hoc power analysis will be performed using G*power 3.1 programme. Data Collection Tools Child Data Collection Form, Child State-Trait Anxiety Inventory, Me and My Emotions Scale in Children and Adolescents, Child and Adolescent Psychological Resilience Scale will be used to collect the data. Data Collection The study will be started after the approval of the ethics commission and permission from the organisation. At the beginning of the study, an introductory meeting will be held with the children and families in order to gain a sense of trust in children and information about the programme will be given. After obtaining consent from the children and their families who agreed to participate in the study, the child data collection form will be filled in by the researchers. Child State-Trait Anxiety Scale, I and My Emotions in Children and Adolescents Scale, Child and Adolescent Psychological Resilience Scale pre-tests will be completed by children. While the children are filling out the forms, the researchers will provide support in reading, explaining the incomprehensible statement and marking if requested. Researchers will not give any guidance to children while providing support. Therapeutic Communication Programme will be started with the children included in the study. After the programme is completed, the final tests of the scales completed by the children will be applied. Implementation of Therapeutic Communication Programme Children and parents will be invited to the container. Children and parents will be informed about the programme. After obtaining verbal consent from the children who want to participate and written consent from their parents, pre-test forms will be applied and physical evaluations will be made. In addition, a one-session training will be organised for the parents. The next day, the 1-week "Therapeutic Communication Programme", which includes 6 modules, will start to be applied to the children. Each module content is planned to last approximately 1 hour. One module will be applied every day. On the 6th day, after the applications are completed, the post-test application of the scales will be carried out. Ethics of the Research In order to decide on the ethical appropriateness of the research, approval will be obtained by applying to Gazi University Ethics Commission. Then, written permission will be obtained from the relevant institutions. Before the data collection process, the researchers will inform the individuals who agree to participate in the research about the research, and after explaining the purpose of the research, verbal consent will be obtained from the children and written consent will be obtained from the parents of the children. The research will be conducted in accordance with the principles of the Declaration of Helsinki. Physical assessment (vital signs, posture, assessment of respiration, assessment of bowel movements, assessment of musculoskeletal system, questioning of current disease status, oral examination, skin assessment, cognitive status, etc.) and anthropometric measurements (height and body weight) will be performed in a separate room in the service container. No one other than the child and his/her parent will be allowed in the room. Data Evaluation Statistical analyses will be performed in IBM SPSS for Windows Version 21.0 package programme. Numerical variables that fit the normal distribution will be analysed by independent groups t-test and one-way analysis of variance (ANOVA). Mann-Whitney U and Kruskal-Wallis tests will be used for comparisons of non-normally distributed numerical measurements. Intergroup comparisons of categorical variables will be analysed by Chi-Square tests. Post-Hoc tests will be used to determine the groups that create the difference in comparisons with significant differences. For all hypothesis tests, the statistical significance level will be set as ≤ 0,05. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06275711
Study type Interventional
Source Gazi University
Contact
Status Completed
Phase N/A
Start date November 30, 2023
Completion date December 6, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Recruiting NCT04356924 - Psychological Treatment to Support the Consequences of Cognitive Impairment N/A
Terminated NCT04241055 - Values Affirmation to Improve Teachers' Outcomes N/A
Active, not recruiting NCT04109677 - AIM CONTROL and SWECON - Handball The SWEdish CONcussion Study in Elite Handball
Recruiting NCT03624348 - The Impact of 8 Weeks of a Digital Meditation Application on Work Stress N/A
Recruiting NCT03706807 - Effect of the Mindfulness-Based Health Promotion Program (MBHP) in the Elderly: a RCT N/A
Recruiting NCT05949047 - Smartphone-based Cognitive Emotion Regulation Training for Unpaid Primary Caregivers of Persons With Alzheimer's Disease N/A
Completed NCT06010407 - Examining the Attitudes of Physiotherapists on Patient Psychology
Not yet recruiting NCT05442294 - "Juego de LLaves": Study Protocol of a Universal School-based Drug Use Prevention Program (PSIDUP) N/A
Active, not recruiting NCT05419167 - STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic Phase 1
Completed NCT04848948 - Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health N/A
Completed NCT05849792 - Internet-based Physical Activities Randomized Controlled Trial in Mild/Moderate Depression Participants: SONRIE Project N/A
Active, not recruiting NCT03610594 - Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children N/A
Completed NCT05510414 - Evaluation of a Psychological Capital Intervention to Alleviate Burnout and Regulate Immunity Among Oncology Nurses N/A
Completed NCT05149066 - #KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents N/A
Completed NCT05264792 - Remote Coaching for Supporting the Implementation of Depression Care in Primary Care in Rural India N/A
Enrolling by invitation NCT05977894 - Floatation Experience in Nurses and Physicians
Recruiting NCT05616988 - Metabolomic Evaluation of Psycho-surgical Synergy on Body Image Restoration After Breast Cancer N/A
Completed NCT04147741 - Effects of a Pre-Workout on Performance, Perceptual Responses, Energy Feelings and Muscular Properties, After a Training Microcycle in Adults. N/A