Emotion Diary Application

October 7, 2026 updated by: Özge KOKSAL, Gazi University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • ÇANKAYA
      • Ankara, ÇANKAYA, Turkey (Türkiye), 06930
        • Ankara Bilkent City Hospital
        • Contact:
          • CITY HOSPITAL I Üniversiteler Neighborhood, 6000th Avenue No: 9, Bilkent/Çanka
          • Phone Number: 0312 552 60 00
          • Email: ankarasehir@saglik.gov.tr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental

9-14 years children
Behavioral: Emotion Diary Administration

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
No Intervention: No Intervention

9-14 years children

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Change relative to the baseline value on day 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child and Adolescent Mindfulness Scale
Time Frame: Change relative to the baseline value on day 5

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.
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

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
Change relative to the baseline value on day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ebru b KILIÇARSLAN, Professor, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026 - 366
  • Gazi Universiyt Bap (Other Identifier: Proje ID:11649)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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