- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07562802
THE EFFECTS OF VIRTUAL ART THERAPY ON PHYSIOLOGICAL PARAMETERS, DELIRIUM RISK, ANGER, ANXIETY, AND MENTAL AND SPIRITUAL RECOVERY IN INTENSIVE CARE PATIENTS.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Seher Çevik, PhD
- Número de teléfono: +905531463844
- Correo electrónico: seherrcvk@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Being 18 years of age or older Voluntarily agreeing to participate in the study Having no medical diagnosis that may trigger dizziness Having a score of 14 or higher on the Glasgow Coma Scale
Exclusion Criteria:
- Refusing to participate in the study Having any psychiatric diagnosis Having a medical diagnosis that may trigger dizziness Having a score of 13 or lower on the Glasgow Coma Scale
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention
Patients in the intervention group will engage in a virtual painting activity once daily for three consecutive days using a virtual reality (VR) headset. The Meta Quest 3 VR headset and hand controllers will be utilized in the study. For the painting activity, the Vermillion - VR Painting application will be employed. This application is a sophisticated platform that simulates the traditional oil painting experience within a virtual reality environment. Rather than primarily offering pre-designed templates, it enables users to create original artworks on a blank canvas by using digital reproductions of physical painting materials, thereby supporting the authentic artistic creation process. Educational reference images and basic composition guides are also available within the application. The duration of each painting session may vary considerably depending on the participant's experience level, the complexity of the work, and the intended level of detail. While a simple sketch or stu |
The Vermillion - VR Painting application will be used to have the patient paint. This application is a sophisticated tool that simulates the traditional oil painting experience in a virtual reality environment. Users can create original works starting from a completely blank canvas; the application primarily supports the artistic creation process by using digital reproductions of real physical painting materials rather than offering ready-made templates. In addition, reference images and basic composition guides are available for educational purposes. The duration of a painting activity can vary significantly depending on the user's experience level, the complexity of the work, and the level of detail targeted; a simple sketch or study may take 15-30 minutes, while a complex composition or portrait may require several hours, or even multiple sessions for experienced users. The writing areas can be extended as needed. |
|
Sin intervención: control
No intervention will be administered to the control group throughout the study period, and patients will continue to receive routine medical and nursing care.
Parallel to the experimental group, on the third day, patients in the control group will be administered the Nursing Delirium Screening Scale, the State Anger Scale, the Integrated Anxiety Scale, and the Mental and Spiritual Recovery Assessment Scale - Short Form.
Vital signs will also be measured and recorded at that time.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Nursing Delirium Screening Scale (Nu-DESC)
Periodo de tiempo: 3 day
|
The Nursing Delirium Screening Scale (Nu-DESC) was developed by Gaudreau et al. in 2005.
The Turkish adaptation of the scale was conducted by Karataş and Bağlama (2021).
Nu-DESC is a rapid and practical screening tool that can be easily implemented in routine nursing practice.
The scale consists of five items assessed based on nurses' clinical observations: disorientation, inappropriate behavior, inappropriate communication, illusions/hallucinations, and psychomotor retardation.
Each item is scored from 0 (absent) to 2 (severe), with a maximum possible total score of 10.
The evaluation is based on observations accumulated over a 12-hour period.
A total score of 2 or higher is considered positive for delirium.
The internal consistency coefficient of the scale was reported as 0.74 (Karataş & Samancıoğlu, 2023).
|
3 day
|
|
State Anger Scale
Periodo de tiempo: 3 days
|
The State Anger Scale, developed by Spielberger (1999), is a unidimensional instrument designed to assess individuals' current level of anger.
The Turkish adaptation was conducted by Cankardaş and Şalcıoğlu.
The scale consists of 10 items, each rated on a 4-point Likert scale (1 = Not at all, 2 = Somewhat, 3 = Moderately, 4 = Very much).
Total scores range from 10 to 40, with higher scores indicating higher levels of state anger.
The internal consistency coefficient was reported as 0.94 (Cankardaş & Şalcıoğlu, 2021).
|
3 days
|
|
Integrated Anxiety Scale:
Periodo de tiempo: 3 days
|
The Integrated Anxiety Scale was developed by Ebadi (2020) and consists of 33 items.
Each item is rated on a 5-point scale ranging from 0 (Never) to 4 (Always).
The total score ranges from 0 to 132, with higher scores indicating higher levels of anxiety and stress.
The internal consistency coefficient of the scale was reported as 0.96.
|
3 days
|
|
Mental and Spiritual Recovery Assessment Scale - Short Form
Periodo de tiempo: 3 days
|
The Mental and Spiritual Recovery Assessment Scale - Short Form was developed by Barber et al. (2017) to evaluate individuals' levels of mental and spiritual recovery.
The Turkish adaptation was conducted by Danış and Günaydın (2024).
The scale consists of 15 items rated on a 5-point Likert scale (1 = Strongly disagree to 5 = Strongly agree).
It includes three subdimensions: Existential Well-Being, Religious Well-Being, and Spiritual Distress.
The total score ranges from 15 to 75, with higher scores indicating greater levels of mental and spiritual recovery.
The internal consistency coefficient (Cronbach's alpha) of the Turkish version was reported as 0.864 for the total scale, with subscale coefficients ranging from 0.773 to 0.953.
The Turkish validity and reliability study demonstrated adequate construct validity, linguistic validity, and item analysis results.
|
3 days
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- inonu university 2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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