PsychologicalNCT06275711
The Effect of Therapeutic Communication Program on the Psychological State of Children
A study testing Therapeutic communication methods in people with Psychological, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological
- What is being tested?
- Therapeutic communication methods
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2023to 6 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- Children with psychological diagnoses (since exclusion from the group is not ethically appropriate, these children will be allowed to participate in the trainings, but the data obtained will not be included in the sample group).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
K-1 Container City
Adıyaman, Altınsehir, 02040
About this study
Official title: The Effect of Therapeutic Communication Program on the Psychological State of Children Affected by the Kahramanmaras Earthquake in Türkiye
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.
Read more
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.
Read the detailed 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.
- Conditions
- Psychological
- Being tested
- Therapeutic communication methods
- Keywords
- children, earthquake, anxiety, affection, psychological resilience
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic communication methodsBehavioural
Drawing pictures, story completion, breathing and relaxation exercises
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic communication | Experimental | Therapeutic communication methods were applied. Pre-test and post-test measurements were made Receives: Behavioral: Therapeutic communication methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: before the study is started (day 1) / after the study is completed (day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start30 Nov 2023
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-test post-test quasi-experimental study
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Gizem Çakır, Gazi University
- Investigators
- Gizem Cakir, PhD(c), Principal investigator, Gazi University Nursing FacultyRukiye Celik, PhD(c), Principal investigator, Gazi University Nursing FacultyNaime Altay, PhD, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275711
- Sponsor's protocol ID
- 223K003
- Status last verified
- Oct 2024
- First submitted
- 5 Feb 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32876808Sever 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.
PubMed 31422466
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Communication Program on the Psychological State of Children Affected by the Kahramanmaras Earthquake in Türkiye
- ClinicalTrials.gov ID
- NCT06275711
- Acronym / sponsor ID
- 223K003
- Conditions
- Psychological
- Keywords
- children, earthquake, anxiety, affection, psychological resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-test post-test quasi-experimental study
| Arm | Type | Receives |
|---|---|---|
| Therapeutic communication | Experimental | Behavioral: Therapeutic communication methodsTherapeutic communication methods were applied. Pre-test and post-test measurements were made |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- Children with psychological diagnoses (since exclusion from the group is not ethically appropriate, these children will be allowed to participate in the trainings, but the data obtained will not be included in the sample group).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic communication methodsDrawing pictures, story completion, breathing and relaxation exercises | Behavioural | Therapeutic communication |
Primary outcome
State Anxiety Scale on Children
Time frame: before the study is started (day 1) / after the study is completed (day 7)
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.
Trait Anxiety Scale on Children
Time frame: before the study is started (day 1) / after the study is completed (day 7)
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.
Me and My Feelings Scale on Children
Time frame: before the study is started (day 1) / after the study is completed (day 7)
The score range for emotional difficulties and behavioural difficulties is 0-20 and 0-12, respectively.
Child and Youth Resilience Measure
Time frame: before the study is started (day 1) / after the study is completed (day 7)
High scores obtained from the scale indicate a high level of psychological resilience. There is no cut-off value.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Background: PubMed 32876808Blanc 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.
- Background: PubMed 31422466Sever 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.
- Children's earthquake preparedness and risk perception: A comparative study of two cities in Turkey, using a modified PRISM approachLink provided by the sponsor.
- Impact evaluation of a school-based disaster education program in a city affected by the 2011 great East Japan earthquake and tsunami disasterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Cakir, PhD(c) principal investigator
Gazi University Nursing Faculty
Rukiye Celik, PhD(c) principal investigator
Gazi University Nursing Faculty
Naime Altay, PhD principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic communication methods in people with Psychological, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Scale on Children (time frame: before the study is started (day 1) / after the study is completed (day 7)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06275711, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.