- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07560241
The Effects of an Intermodal Art Therapy Program on Depression, Anxiety, Stress, and Emotion Regulation Skill Levels in Nursing Students: A Randomized Controlled Study
24 de abril de 2026 actualizado por: Atlas University
Nursing students face stress during their education, especially when transitioning to clinical practice; poorly managed stress reduces academic achievement and increases levels of depression and anxiety.
Therefore, developing students' emotional awareness and coping skills is important.
Art therapy is an effective method that supports individuals in self-expression and the development of emotion regulation skills.
Although the literature shows positive effects of art-based interventions on psychological well-being, there are limited randomized controlled studies that address depression, anxiety, stress, and emotion regulation skills together in nursing students.
Accordingly, this study aims to determine the effect of an intermodal art therapy program on these variables in nursing students.
The research was planned as a two-group, single-blind, observational, randomized controlled interventional study.
The population of the study will consist of 1st and 2nd-year nursing students studying at Istanbul Atlas University, and 44 students meeting the inclusion-exclusion criteria will constitute the sample of the study.
The intermodal art therapy program will be applied to the intervention group.
Data; Data will be collected using an Individual Demographic Form, the Depression, Anxiety, Stress Scale, and the Emotion Regulation Skills Scale.
Interventions will be administered in approximately grouped sessions, once a week, for a total of 8 sessions, each lasting 90 minutes, in a structured format.
Data analysis will be performed using the SPSS 23.0 software package.
Descriptive statistics such as frequency distribution, mean, and standard deviation will be used to define the sample size; pairwise pairs or the Wilcoxon pairwise test will be used for intragroup comparisons according to parametric test assumptions; and the Chi-square test will be used for the analysis of categorical data.
A 95% significance level will be used to determine differences in the analyses.
This study aims to contribute to strengthening the psychosocial care of nursing students by providing evidence on the effectiveness of an intermodal art therapy program applied to nursing students.
Descripción general del estudio
Estado
Inscripción por invitación
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
44
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.
Ubicaciones de estudio
-
-
Istanbul
-
Istanbul, Istanbul, Turquía (Türkiye), 34408
- Istanbul Atlas University
-
-
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
- Niño
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Being enrolled in the 1st or 2nd year of the Nursing Department at Istanbul Atlas University in the Spring Semester of 2025-2026,
- Voluntarily participating in the research
Exclusion Criteria:
- Having any comprehension or speech impairment,
- Having any psychiatric diagnosis,
- Being on any psychotropic medication,
- Being enrolled in another program using a similar method that could affect the study's outcome
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Art Therapy Group
In the study, it was planned to apply art therapy program the independent variable to the intervention group in 8 sessions of 90-120 minutes, one days a week, and no intervention was planned for the control group.
|
Intermodal art therapy program
Otros nombres:
|
|
Sin intervención: Comparison group
No intervention was planned for the control group.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Depression, anxiety, stress
Periodo de tiempo: Pre-test (8 weeks before intervention) Post-test (8 weeks after intervention) Follow-up (1 month after post-test evaluation)
|
Depression, Anxiety, Stress Scale (DASS-21) Lovibond and Lovibond (1995) created DASS-21 by shortening DASS-42.
Sarıçam (2018) performed psychometric tests on the Turkish version of the "Depression Anxiety Stress-21 Scale (DASS-21)" in normal and clinical samples.
In the normal sample, test-retest correlation coefficients were found to be r=0.68 for the depression subscale, r=0.66 for the anxiety subscale, and r=0.61 for the stress subscale.
The scale, which is a four-point Likert type, consists of 7 questions each measuring the "depression, stress, and anxiety dimensions".
In the depression subscale scores, 0-4 points indicate normal, 5-6 points mild, 7-10 points moderate, 11-13 points advanced, and 14 points and above indicate very advanced depression.
In the anxiety subscale, scores between 0-3 indicate normal, 4-5 indicates mild, 6-7 indicates moderate, 8-9 indicates advanced, and 10 and above indicates very advanced anxiety levels.
In the stress subscale, scores between 0-7 indic
|
Pre-test (8 weeks before intervention) Post-test (8 weeks after intervention) Follow-up (1 month after post-test evaluation)
|
|
Emotion Regulation Skills
Periodo de tiempo: Pre-test (8 weeks before intervention) Post-test (8 weeks after intervention) Follow-up (1 month after post-test evaluation)
|
Emotion Regulation Skills Scale (EDS) This is a scale developed by Berking and Znoj (2008) to determine individuals' emotion regulation skills.
The adaptation of the scale into Turkish, and its validity and reliability study, were carried out by Vatan and Kâhya (2018).
The scale is a self-report instrument consisting of 27 items with a five-point Likert scale (0=almost never, 4=almost always).
The Emotional Behavior Test (EBT) encompasses nine sub-dimensions: awareness/attention (e.g., 'I paid attention to my feelings.'),
bodily sensations (e.g., 'My physical sensations were a good indicator of how I felt.'),
clarity (e.g., 'I was sure of which emotions I was experiencing.'),
understanding (e.g., 'I was aware of why I felt that way.'), acceptance (e.g., 'I accepted my emotions.'),
tolerance (e.g., 'I felt I could tolerate my negative emotions.'),
preparedness for confrontation (e.g., 'Even though it made me feel uncomfortable or anxious, I did what I planned.'),
self-support (e.g., 'I
|
Pre-test (8 weeks before intervention) Post-test (8 weeks after intervention) Follow-up (1 month after post-test evaluation)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
29 de abril de 2026
Finalización primaria (Estimado)
18 de junio de 2026
Finalización del estudio (Estimado)
18 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
24 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de abril de 2026
Publicado por primera vez (Actual)
1 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Síntomas de comportamiento
- Comportamiento
- Desórdenes de ansiedad
- Depresión
- Terapéutica
- Terapias complementarias
- Atención al paciente
- Psicoterapia
- Disciplinas y actividades de comportamiento
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Terapias de arte sensorial
- Terapia de arte
Otros números de identificación del estudio
- 01313
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
We can share if necessary
Marco de tiempo para compartir IPD
6 months
Criterios de acceso compartido de IPD
Contacting authors
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
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. .