Emotional StatesNCT06956586
Therapeutic Communication Techniques for Children Aged 7-12 in Intensive Care
A study testing Therapeutic communication techniques in people with Emotional States and Therapeutic Communication in Pediatric ICU, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
Summary of the Research Children may need to stay in intensive care for a period of time due to acute or chronic illnesses in their lives.There may be anxiety, fear and concerns in intensive care. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Emotional States, Therapeutic Communication in Pediatric ICU, Child Emotional Well-being in ICU
- What is being tested?
- Therapeutic communication techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 26 Jan 2025
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 7 and 12 years,
- Receiving treatment in an intensive care unit,
- Children and families who agree to participate in the study,
- Conscious with a Glasgow Coma Scale (GCS) score of 15,
- First-time experience in an intensive care unit,
- Able to speak and understand Turkish,
- Not experiencing intense symptoms such as pain or nausea during the procedure,
- Children monitored at levels 1 and 2 will be included.
Who cannot join
- The child has a chronic illness requiring frequent hospitalizations and treatment,
- The child has a medically diagnosed psychological disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Ethical Approval From Gazi University Has Been Obtained.The Institutional Approval From Bilkent City Hospital Has Been Obtained.
Summary of the Research Children may need to stay in intensive care for a period of time due to acute or chronic illnesses in their lives.There may be anxiety, fear and concerns in intensive care. Therefore, a healthy communication with the child, such as care, accurate transfer and reporting of the events and situations experienced according to the development level, the use of appropriate therapeutic communication, the child's mental and spiritual life includes all lives. The aim of this study is to examine the effects of therapeutic communication techniques applied to the 7-12 age groups in intensive care on the emotional development of children. The research will be patterned later. The research storage will consist of 70 children between the ages of 7-12 who are hospitalized in the Intensive Care Unit of Ankara Bilkent City Hospital Pediatric Intensive Care Unit and Uşak University Education and Research Hospital. Data will be collected with 1. Descriptive Data Form Related to the Child and Family, 2. State Anxiety Inventory, 3. Koppitz's Human Figure Drawing Test, 4. "Facial Expressions Rating Scale" in Wong and Baker.
Purpose of the study: The purpose of this study is to examine the effects of therapeutic communication techniques applied to children aged 7-12 in intensive care on the emotional state of the children.
Read more
Hypotheses of the Study:
H1.1: The average total score of the state anxiety scale in the intervention group (children receiving therapeutic communication techniques) will differ from that of the control group (children not receiving therapeutic communication techniques).
H1.2: The emotional state of the children in the intervention group, as measured by the Koppitz Human Figure Drawing Test, will differ from the emotional state of children in the control group.
Before the therapeutic communication method is applied to the children in the intervention and control groups, the descriptive characteristics data form, the State Anxiety Inventory, the Facial Expressions Rating Scale, and the Emotion Wheel will be applied.
The forms will be shown to the child by the researcher at the child's bedside in the intensive care unit and filled out face to face by the researcher. After the therapeutic communication intervention is completed, Koppitz's Human Figure Drawing Test and State Anxiety Inventory will be applied to the children in the intervention and control groups. The estimated application time of the forms is 30 minutes. The application will last 2 days.
DAY 1: Application of joint storytelling as a therapeutic communication technique by the researcher to the children DAY 2: Application of picture drawing technique as a therapeutic communication technique by the researcher to the children
Read the detailed description
Study Design: study is designed as a randomized controlled trial to evaluate the effects of therapeutic communication techniques on the emotional development of children aged 7-12 in intensive care units.
Participants:
The study will include 70 children aged 7-12 years who are admitted to the Pediatric Intensive Care Units of Ankara Bilkent City Hospital and Uşak University Training and Research Hospital.
Randomization:To reduce selection bias and control for variables that may affect outcome parameters, participants will be randomly assigned to either the intervention group, which will receive therapeutic communication techniques, or the control group, which will receive standard care.In order to ensure homogeneity between groups, it will be created with the existing stratification method.The CONSORT 2022 (Updated Guidelines for Reporting Randomized Parallel Group Trials) report will be followed during the randomization phase The data obtained in the study will be evaluated in the computer environment with the SPSS 27.0 package data program. The conformity of the data to normal distribution will be examined with descriptive statistics (skewness, kurtosis), hypothesis tests (Kolmogorov-Smirnov/Shapiro-Wilk tests) and visually (histogram and probability graphs). In comparisons between groups, single-factor covariance analysis (ANCOVA) will be applied to eliminate bias in normally distributed data, and Mann Whitney U test will be applied for non-normally distributed data. In intra-group evaluations, the significance test of the difference between two pairs will be used for normally distributed ordinal data, and the Wilcoxon paired two-sample test will be used for non-normally distributed ones. Chi-square test will be used in comparisons of nominal data between groups.
Ethical Aspects of the Research A permit numbered 09 dated 12.07.2024 was obtained from the Gazi University Ethics Committee for the implementation of the data collection forms. Written consent will be obtained from the patient child and his/her family to be included in the study, and the identity and medical conditions of the participants will be kept confidential. The children in the control group will be subjected to the technique of drawing pictures and telling stories after the study.
- Conditions
- Emotional States, Therapeutic Communication in Pediatric ICU, Child Emotional Well-being in ICU
- Being tested
- Therapeutic communication techniques
- Keywords
- Therapeutic Communication, Intensive Care Unit (ICU), Pediatric Care, Child Psychological Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic communication techniquesOther
Therapeutic communication techniques will be applied to children in the intensive care unit for two days."
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Communication Techniques | Experimental | Participants in the intervention group will participate in therapeutic communication sessions using storytelling and drawing techniques for 2 days. Receives: Other: Therapeutic communication techniques |
| Standard Care | No intervention | The control group will receive standard care. After the study is completed, therapeutic communication techniques will also be applied to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory
The State-Trait Anxiety Inventory is a psychological inventory that measures the level of anxiety in individuals. It consists of two separate scales: one that measures state anxiety (the temporary anxiety experienced at a specific moment or situation) and one that measures trait anxiety (the general tendency to experience anxiety in a variety of situations).It was developed to assess how children feel at that moment. It consists of 20 items and aims to assess feelings related to state anxiety. The options in this form are scored as "not at all" (1), "a little" (2), "a lot" (3), "always" (4). The highest score that can be obtained from the State Anxiety Inventory is 80 and the lowest score is 20. A high score indicates a high anxiety state. A low score indicates a low anxiety state.
Measured: Before and immediately after the application of therapeutic communication techniques."
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Aug 2024
- Primary completion26 Jan 2025
- Study completion26 Jan 2025
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 Emotional StatesStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Köksal, Uşak University
- Investigators
- Serhat Emeksiz, Assoc. Prof., Study director, Bilkent City HospitalEbru Kılıçarslan, Professor, Study director, Gazi UnivercıtyÖzge Köksal, Research Assistant, Principal investigator, Uşak Univercıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956586
- Sponsor's protocol ID
- E-14774941-199-996608
- Status last verified
- Aug 2025
- First submitted
- 25 Apr 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rennick JE, Stremler R, Horwood L, Aita M, Lavoie T, Majnemer A, Antonacci M, Knox A, Constantin E. A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music. Pediatr Crit Care Med. 2018 Jul;19(7):e358-e366. doi: 10.1097/PCC.0000000000001556.
PubMed 29659416Koksal O, Kilicarslan E, Emeksiz S. Drawing and mutual storytelling to alleviate anxiety and improve emotional well-being in children in PICU: a randomized controlled trial. Eur J Pediatr. 2025 Sep 5;184(9):602. doi: 10.1007/s00431-025-06454-5.
PubMed 40913193
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ethical Approval From Gazi University Has Been Obtained.The Institutional Approval From Bilkent City Hospital Has Been Obtained.
- ClinicalTrials.gov ID
- NCT06956586
- Acronym / sponsor ID
- E-14774941-199-996608
- Conditions
- Emotional States, Therapeutic Communication in Pediatric ICU, Child Emotional Well-being in ICU
- Keywords
- Therapeutic Communication, Intensive Care Unit (ICU), Pediatric Care, Child Psychological Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 26 Jan 2025 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 4 May 2025 (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.
Summary of the Research Children may need to stay in intensive care for a period of time due to acute or chronic illnesses in their lives.There may be anxiety, fear and concerns in intensive care. Therefore, a healthy communication with the child, such as care, accurate transfer and reporting of the events and situations experienced according to the development level, the use of appropriate therapeutic communication, the child's mental and spiritual life includes all lives. The aim of this study is to examine the effects of therapeutic communication techniques applied to the 7-12 age groups in intensive care on the emotional development of children. The research will be patterned later. The research storage will consist of 70 children between the ages of 7-12 who are hospitalized in the Intensive Care Unit of Ankara Bilkent City Hospital Pediatric Intensive Care Unit and Uşak University Education and Research Hospital. Data will be collected with 1. Descriptive Data Form Related to the Child and Family, 2. State Anxiety Inventory, 3. Koppitz's Human Figure Drawing Test, 4. "Facial Expressions Rating Scale" in Wong and Baker.
Purpose of the study: The purpose of this study is to examine the effects of therapeutic communication techniques applied to children aged 7-12 in intensive care on the emotional state of the children.
Hypotheses of the Study:
H1.1: The average total score of the state anxiety scale in the intervention group (children receiving therapeutic communication techniques) will differ from that of the control group (children not receiving therapeutic communication techniques).
H1.2: The emotional state of the children in the intervention group, as measured by the Koppitz Human Figure Drawing Test, will differ from the emotional state of children in the control group.
Before the therapeutic communication method is applied to the children in the intervention and control groups, the descriptive characteristics data form, the State Anxiety Inventory, the Facial Expressions Rating Scale, and the Emotion Wheel will be applied.
The forms will be shown to the child by the researcher at the child's bedside in the intensive care unit and filled out face to face by the researcher. After the therapeutic communication intervention is completed, Koppitz's Human Figure Drawing Test and State Anxiety Inventory will be applied to the children in the intervention and control groups. The estimated application time of the forms is 30 minutes. The application will last 2 days.
DAY 1: Application of joint storytelling as a therapeutic communication technique by the researcher to the children DAY 2: Application of picture drawing technique as a therapeutic communication technique by the researcher to the children
Detailed description
Study Design: study is designed as a randomized controlled trial to evaluate the effects of therapeutic communication techniques on the emotional development of children aged 7-12 in intensive care units.
Participants:
The study will include 70 children aged 7-12 years who are admitted to the Pediatric Intensive Care Units of Ankara Bilkent City Hospital and Uşak University Training and Research Hospital.
Randomization:To reduce selection bias and control for variables that may affect outcome parameters, participants will be randomly assigned to either the intervention group, which will receive therapeutic communication techniques, or the control group, which will receive standard care.In order to ensure homogeneity between groups, it will be created with the existing stratification method.The CONSORT 2022 (Updated Guidelines for Reporting Randomized Parallel Group Trials) report will be followed during the randomization phase The data obtained in the study will be evaluated in the computer environment with the SPSS 27.0 package data program. The conformity of the data to normal distribution will be examined with descriptive statistics (skewness, kurtosis), hypothesis tests (Kolmogorov-Smirnov/Shapiro-Wilk tests) and visually (histogram and probability graphs). In comparisons between groups, single-factor covariance analysis (ANCOVA) will be applied to eliminate bias in normally distributed data, and Mann Whitney U test will be applied for non-normally distributed data. In intra-group evaluations, the significance test of the difference between two pairs will be used for normally distributed ordinal data, and the Wilcoxon paired two-sample test will be used for non-normally distributed ones. Chi-square test will be used in comparisons of nominal data between groups.
Ethical Aspects of the Research A permit numbered 09 dated 12.07.2024 was obtained from the Gazi University Ethics Committee for the implementation of the data collection forms. Written consent will be obtained from the patient child and his/her family to be included in the study, and the identity and medical conditions of the participants will be kept confidential. The children in the control group will be subjected to the technique of drawing pictures and telling stories after the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Communication Techniques | Experimental | Other: Therapeutic communication techniquesParticipants in the intervention group will participate in therapeutic communication sessions using storytelling and drawing techniques for 2 days. |
| Standard Care | No intervention | –The control group will receive standard care. After the study is completed, therapeutic communication techniques will also be applied to the control group |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Aged between 7 and 12 years,
- Receiving treatment in an intensive care unit,
- Children and families who agree to participate in the study,
- Conscious with a Glasgow Coma Scale (GCS) score of 15,
- First-time experience in an intensive care unit,
Key exclusion criteria (2 listed)
- The child has a chronic illness requiring frequent hospitalizations and treatment,
- The child has a medically diagnosed psychological disorder.
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 techniquesTherapeutic communication techniques will be applied to children in the intensive care unit for two days." | Other | Therapeutic Communication Techniques |
Primary outcome
State-Trait Anxiety Inventory
Time frame: Before and immediately after the application of therapeutic communication techniques."
The State-Trait Anxiety Inventory is a psychological inventory that measures the level of anxiety in individuals. It consists of two separate scales: one that measures state anxiety (the temporary anxiety experienced at a specific moment or situation) and one that measures trait anxiety (the general tendency to experience anxiety in a variety of situations).It was developed to assess how children feel at that moment. It consists of 20 items and aims to assess feelings related to state anxiety. The options in this form are scored as "not at all" (1), "a little" (2), "a lot" (3), "always" (4). The highest score that can be obtained from the State Anxiety Inventory is 80 and the lowest score is 20. A high score indicates a high anxiety state. A low score indicates a low anxiety state.
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 12 Aug 2025.
- Background: PubMed 29659416Rennick JE, Stremler R, Horwood L, Aita M, Lavoie T, Majnemer A, Antonacci M, Knox A, Constantin E. A Pilot Randomized Controlled Trial of an Intervention to Promote Psychological Well-Being in Critically Ill Children: Soothing Through Touch, Reading, and Music. Pediatr Crit Care Med. 2018 Jul;19(7):e358-e366. doi: 10.1097/PCC.0000000000001556.
- Derived from this study: PubMed 40913193Koksal O, Kilicarslan E, Emeksiz S. Drawing and mutual storytelling to alleviate anxiety and improve emotional well-being in children in PICU: a randomized controlled trial. Eur J Pediatr. 2025 Sep 5;184(9):602. doi: 10.1007/s00431-025-06454-5.
- Ankara Bilkent City HospitalLink 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.
Serhat Emeksiz, Assoc. Prof. study director
Bilkent City Hospital
Ebru Kılıçarslan, Professor study director
Gazi Univercıty
Özge Köksal, Research Assistant principal investigator
Uşak Univercıty
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 techniques in people with Emotional States and Therapeutic Communication in Pediatric ICU, run by Uşak 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 8 inclusion and 2 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 12 Aug 2025. 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-Trait Anxiety Inventory (time frame: Before and immediately after the application of therapeutic communication techniques."). 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 NCT06956586, 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 12 Aug 2025.