Emotion JournalNCT07860190
Emotion Diary Application
A study testing Emotion Diary Administration in people with Emotion Journal and Pediatric Intensive Care, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Pediatric patients, hospitalization in a pediatric intensive care unit (PICU) is not merely a situation requiring physical treatment, but also an experience that has significant psychosocial effects. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Journal, Pediatric Intensive Care, Emotion Regulation
- What is being tested?
- Emotion Diary Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2027to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 9-14 years
- Those who voluntarily agree to participate in the study
- Those who are not intubated and are able to communicate
- Those who are conscious
- Children admitted to the intensive care unit will be accepted into the study.
Who cannot join
- Those with visual, hearing, or neurological/mental impairments that hinder communication;
- Those with cognitive limitations severe enough to prevent them from responding to the scales;
- Those under sedation;
- Children whose clinical condition does not permit the 30-minute intervention; and
- Children and parents who do not wish to participate in the study.
- Withdrawal Criteria:
- Those unable to participate in the program for more than 2 days of the five-day schedule.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, ÇANKAYA, 06930
CITY HOSPITAL I Üniversiteler Neighborhood, 6000th Avenue No: 9, Bilkent/Çanka, 0312 552 60 00, ankarasehir@saglik.gov.tr
About this study
Official title: The Effect of the Emotion Diary Application on Awareness, Emotion Regulation, and Anxiety Levels in Pediatric Patients
Pediatric patients, hospitalization in a pediatric intensive care unit (PICU) is not merely a situation requiring physical treatment, but also an experience that has significant psychosocial effects. This project was designed to evaluate the effect of a mood journal intervention on anxiety levels, mindfulness, and emotion regulation skills in conscious pediatric patients aged 9-14 years in a pediatric intensive care unit. An emotion journal is a supportive tool that allows children to express the experiences they have during the day, the emotions they feel, and their reactions to these emotions in a structured format. It is anticipated that this practice may help children develop their abilities to recognize, express, and regulate their emotions; it may also reduce their anxiety levels related to the intensive care process. Children admitted to the pediatric intensive care unit who are conscious, able to communicate, and meet the inclusion criteria will be assigned to the intervention and control groups using a randomization method. At the start of the study, both groups will be provided with the Child and Parent Information Form, the Child and Adolescent Mindfulness Scale, the Emotion Regulation Scale for Children and Adolescents, and the State Anxiety Scale for Children will be administered to both groups. The intervention group will participate in an emotion journaling program for 5 days, approximately 30 minutes per day, while the control group will receive routine clinical care. Data will be analyzed using the SPSS 30.0 statistical software; descriptive statistics, normality tests, parametric or non-parametric group comparison tests, and correlation analyses will be performed. As a result of the project, it is expected that the emotion journaling intervention will reduce children's anxiety levels, increase their mindfulness, and support their emotion regulation skills. It is anticipated that the findings will contribute to the development of implementable, low-cost, and child-centered psychosocial care interventions in pediatric intensive care units.
- Being tested
- Emotion Diary Administration
- Keywords
- child, pediatric, intensive care, emotion regulation, therapeutic communication
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Diary AdministrationBehavioural
Emotion Diary Administration Protocol The emotion diary to be administered to children in the experimental group will be a structured material developed by the researchers. The emotion diary will be administered to children aged 9-14 who are hospitalized in the pediatric intensive care unit, are conscious, able to communicate, and meet the inclusion criteria for the study, for a period of 5 days, for approximately 30 minutes each day. All sessions will be conducted by the researchers; the journal will be completed by the child themselves. The emotion journal is structured to help children become aware of the experiences they go through during their time in intensive care, the emotions they feel, and how these emotions manifest in their bodies and behaviors, and to assist them in developing appropriate coping strategies. The journal will include sections appropriate for the children's age level, such as selecting emotions, naming emotions, written expression, short-answer questions, dr
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 9-14 years children Receives: Behavioral: Emotion Diary Administration |
| No Intervention | No intervention | 9-14 years children |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Scale for Children
The State Anxiety Scale for Children was developed by Spielberger et al. in 1970.
This scale was developed to assess children's momentary emotional states. Its validity in Turkish was established by Öner and Le Compte in 1985. It was translated into Turkish by Özusta (1995).
The response fields can be extended as needed. The scale consists of 20 items and is designed to assess emotions related to state anxiety. The highest possible score on the scale is 80, and the lowest is 20. A high score indicates a high level of anxiety. The scale's Cronbach's alpha coefficient is 0.89 (Spielberger and Edwards, 1973); in the Turkish version, it is 0.82 (Özusta, 1995).
Measured: Change relative to the baseline value on day 5
Secondary outcomes (2)
Child and Adolescent Mindfulness Scale
The scale was developed by Greco et al. (2011), and a study on its validity and reliability in Turkish was conducted by Bilaç et al. (2024). Used to measure mindfulness in children and adolescents aged nine and older, the scale consists of 10 items and is a five-point Likert-type self-report scale (4: always, 3: often, 2: sometimes, 1: rarely, 0: never). The items on the scale are first reverse-coded by changing 0 to 4, 1 to 3, 3 to 1, and 4 to 0 (leaving 2 unchanged), and the total score is calculated by summing all items. Higher scores are considered to indicate a higher level of mindfulness (Bilaç et al., 2024). The scale does not include subscales or cutoff scores. In the original study of the scale, the total Cronbach's alpha coefficient was 0.80 (Greco et al., 2011); in the Turkish adaptation study (Bilaç et al., 2024), it was found to be 0.76.
Measured: Change relative to the baseline value on day 5
Emotional Regulation Scale for Children and Adolescents
Developed by Gullone and Taffe (2012) as an adaptation for children and adolescents of the Emotional Regulation Scale developed by Gross and John (2003). The Turkish adaptation of the scale was conducted by Tetik and Önder (2021). There are no reverse-scored items on the scale.
Items 1, 3, 5, 7, 8, and 10 represent the reappraisal subscale; items 2, 4, 6, and 9 represent the suppression subscale. High scores on the subscales indicate that the emotion regulation strategy represented by that subscale is frequently used (Tetik and Önder, 2021). In the original version of the scale (Gullone and Taffe, 2012), the Cronbach's alpha internal consistency coefficient ranged from 0.82 to 0.86 for the reappraisal subscale and from 0.69 to 0.79 for the suppression subscale. In the Turkish adaptation study, the Cronbach's alpha internal consistency coefficient was found to be 0.79 for the reappraisal subscale and 0.53 for the suppress
Measured: Change relative to the baseline value on day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotion JournalStudies 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, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Responsible party
- Principal investigator, Özge KOKSAL, Gazi University
- Investigators
- Ebru b KILIÇARSLAN, Professor, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860190
- Sponsor's protocol ID
- 2026 - 366
- Other IDs
- Gazi Universiyt Bap
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Calzari S, Villa M, Mauro S, Mirto V, Bulloni P, Zini P, Deelen P, Grassellini PR, Bernasconi S, Cassina T. The intensive care unit diary as a valuable care tool: A qualitative study of patients' experiences. Intensive Crit Care Nurs. 2024 Feb;80:103558. doi: 10.1016/j.iccn.2023.103558. Epub 2023 Oct 10.
PubMed 37826962
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Emotion Diary Application on Awareness, Emotion Regulation, and Anxiety Levels in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07860190
- Acronym / sponsor ID
- 2026 - 366
- Keywords
- child, pediatric, intensive care, emotion regulation, therapeutic communication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- Ankara City Hospital Bilkent
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 6 Oct 2026 (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.
Pediatric patients, hospitalization in a pediatric intensive care unit (PICU) is not merely a situation requiring physical treatment, but also an experience that has significant psychosocial effects. This project was designed to evaluate the effect of a mood journal intervention on anxiety levels, mindfulness, and emotion regulation skills in conscious pediatric patients aged 9-14 years in a pediatric intensive care unit. An emotion journal is a supportive tool that allows children to express the experiences they have during the day, the emotions they feel, and their reactions to these emotions in a structured format. It is anticipated that this practice may help children develop their abilities to recognize, express, and regulate their emotions; it may also reduce their anxiety levels related to the intensive care process. Children admitted to the pediatric intensive care unit who are conscious, able to communicate, and meet the inclusion criteria will be assigned to the intervention and control groups using a randomization method. At the start of the study, both groups will be provided with the Child and Parent Information Form, the Child and Adolescent Mindfulness Scale, the Emotion Regulation Scale for Children and Adolescents, and the State Anxiety Scale for Children will be administered to both groups. The intervention group will participate in an emotion journaling program for 5 days, approximately 30 minutes per day, while the control group will receive routine clinical care. Data will be analyzed using the SPSS 30.0 statistical software; descriptive statistics, normality tests, parametric or non-parametric group comparison tests, and correlation analyses will be performed. As a result of the project, it is expected that the emotion journaling intervention will reduce children's anxiety levels, increase their mindfulness, and support their emotion regulation skills. It is anticipated that the findings will contribute to the development of implementable, low-cost, and child-centered psychosocial care interventions in pediatric intensive care units.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Emotion Diary Administration9-14 years children |
| No Intervention | No intervention | –9-14 years children |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 9-14 years
- Those who voluntarily agree to participate in the study
- Those who are not intubated and are able to communicate
- Those who are conscious
- Children admitted to the intensive care unit will be accepted into the study.
Key exclusion criteria (7 listed)
- Those with visual, hearing, or neurological/mental impairments that hinder communication;
- Those with cognitive limitations severe enough to prevent them from responding to the scales;
- Those under sedation;
- Children whose clinical condition does not permit the 30-minute intervention; and
- Children and parents who do not wish to participate in the study.
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 |
|---|---|---|
| Emotion Diary AdministrationEmotion Diary Administration Protocol The emotion diary to be administered to children in the experimental group will be a structured material developed by the researchers. The emotion diary will be administered to children aged 9-14 who are hospitalized in the pediatric intensive care unit, are conscious, able to communicate, and meet the inclusion criteria for the study, for a period of 5 days, for approximately 30 minutes each day. All sessions will be conducted by the researchers; the journal will be completed by the child themselves. The emotion journal is structured to help children become aware of the experiences they go through during their time in intensive care, the emotions they feel, and how these emotions manifest in their bodies and behaviors, and to assist them in developing appropriate coping strategies. The journal will include sections appropriate for the children's age level, such as selecting emotions, naming emotions, written expression, short-answer questions, dr | Behavioural | Experimental |
Primary outcome
State Anxiety Scale for Children
Time frame: Change relative to the baseline value on day 5
The State Anxiety Scale for Children was developed by Spielberger et al. in 1970. This scale was developed to assess children's momentary emotional states. Its validity in Turkish was established by Öner and Le Compte in 1985. It was translated into Turkish by Özusta (1995). The response fields can be extended as needed. The scale consists of 20 items and is designed to assess emotions related to state anxiety. The highest possible score on the scale is 80, and the lowest is 20. A high score indicates a high level of anxiety. The scale's Cronbach's alpha coefficient is 0.89 (Spielberger and Edwards, 1973); in the Turkish version, it is 0.82 (Özusta, 1995).
2 secondary outcomes
Child and Adolescent Mindfulness Scale
Time frame: Change relative to the baseline value on day 5
Emotional Regulation Scale for Children and Adolescents
Time frame: Change relative to the baseline value on day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 37826962Calzari S, Villa M, Mauro S, Mirto V, Bulloni P, Zini P, Deelen P, Grassellini PR, Bernasconi S, Cassina T. The intensive care unit diary as a valuable care tool: A qualitative study of patients' experiences. Intensive Crit Care Nurs. 2024 Feb;80:103558. doi: 10.1016/j.iccn.2023.103558. Epub 2023 Oct 10.
- Individual participant dataSharing planned: No
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.
Ebru b KILIÇARSLAN, Professor study director
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 Emotion Diary Administration in people with Emotion Journal and Pediatric Intensive Care, 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özge Z KÖKSAL (+905345109208, koksalozge26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety Scale for Children (time frame: Change relative to the baseline value on day 5). 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 NCT07860190, which also lists 1 linked publication.
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 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.