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Emotion Diary Application

7 de octubre de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

64

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • ÇANKAYA
      • Ankara, ÇANKAYA, Turquía (Türkiye), 06930
        • Ankara Bilkent City Hospital
        • Contacto:
          • CITY HOSPITAL I Üniversiteler Neighborhood, 6000th Avenue No: 9, Bilkent/Çanka
          • Número de teléfono: 0312 552 60 00
          • Correo electrónico: ankarasehir@saglik.gov.tr

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

9 años a 14 años (Niño)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Experimental

9-14 years children

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

Sin intervención: No Intervention

9-14 years children

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
State Anxiety Scale for Children
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Child and Adolescent Mindfulness Scale
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Ebru b KILIÇARSLAN, Professor, Gazi University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

1 de junio de 2027

Finalización del estudio (Estimado)

1 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

30 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de septiembre de 2026

Publicado por primera vez (Actual)

6 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2026 - 366
  • Gazi Universiyt Bap (Otro identificador: Proje ID:11649)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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