- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04722367
Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study uses a waitlist control design. Participants will be randomly assigned to either session one or session two.
Regardless if they are registered for Session One or Session Two, each participant will be invited to self-report their stress levels, feelings of being aware of the present moment, and feelings of connection and belonging on a weekly basis. There will be a follow-up survey at the end of Session One and Session Two to compare changes between participants who have already received the intervention and those who have not. In this way, Session One participants act as a control group. This follow-up survey will be utilized once again after Session Two finishes in order to examine whether there is a lasting impact on Session One participants.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520
- Yale University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Yale student
- 18 years of age or older
- Must complete all survey measures
- Must be available Mondays 5-6 pm EST in October and November
Exclusion Criteria:
- Not a Yale student
- Not 18 years of age or older
- Does not complete all survey measures
- Not available Mondays 5-6 pm EST in October and November
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Art Pedagogy and Mindfulness
Each participant will take part in four 1-hour sessions.
Study activities include guided meditation, close looking, drawing, writing, and storytelling.
Each session will begin with a guided meditation that is followed by an exercise inspired by two works of art, and end with an opportunity for students to reflect on the experience.
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Each participant will take part in four 1-hour sessions.
Study activities include guided meditation, close looking, drawing, writing, and storytelling.
Each session will begin with a guided meditation that is followed by an exercise inspired by two works of art, and end with an opportunity for students to reflect on the experience.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in stress from Impact of Being Present with Art Intervention
Periodo de tiempo: Baseline, 4 weeks
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A primary objective of this study is to determine whether mindful engagement with art reduces student stress levels.
This will be measured by the Perceived Stress Scale (min = 0; max = 4) which consists of 10 scale items.
The higher the score, the more likely participants are stressed.
Participants who received the intervention in Session One will be compared to the control (Session Two).
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Baseline, 4 weeks
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Change in mindfulness from Impact of Being Present with Art Intervention
Periodo de tiempo: Baseline, 4 weeks
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A primary objective of this study is to determine whether mindful engagement with art increases mindful awareness in students.
This will be measured by the Mindful Awareness Scale (min = 1; max = 6) which includes 15 questions.
The higher the score, the more mindful participants are.
Participants who received the intervention in Session One will be compared to the control (Session Two).
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Baseline, 4 weeks
|
|
Change in Connectedness from Impact of Being Present with Art Intervention
Periodo de tiempo: Baseline, 4 weeks
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A primary objective of this study is to determine whether mindful engagement with art increases feelings of connectedness in students.
This will be measured by a scale created by the investigators to ask participants how connected they feel to the Yale community (min = 1; max = 5).
This scale involves one question.
The higher the score, the more connected participants feel to the Yale community.
Participants who received the intervention in Session One will be compared to the control (Session Two).
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Baseline, 4 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Longitudinal Impact of Being Present with Art Intervention on Stress
Periodo de tiempo: Baseline, 4 weeks, 8 weeks
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A secondary objective of this study is to determine whether the Being Present with Art intervention resulted in a longitudinal decrease in stress for Session One participants.
This outcome is measured by the Perceived Stress Scale (min = 0; max = 4) which consists of 10 scale items.
The higher the score, the more stressed participants are.
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Baseline, 4 weeks, 8 weeks
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Change in Longitudinal Impact of Being Present with Art Intervention on Mindfulness
Periodo de tiempo: Baseline, 4 weeks, 8 weeks
|
A secondary objective of this study is to determine whether the Being Present with Art intervention resulted in a longitudinal increase in mindfulness for Session One participants.
This outcome is measured by the Mindful Awareness Scale (min = 1; max = 6) which consists of 15 scale items.
The higher the score, the more mindful participants are.
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Baseline, 4 weeks, 8 weeks
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Change in Longitudinal Impact of Being Present with Art Intervention on Connectedness
Periodo de tiempo: Baseline, 4 weeks, 8 weeks
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A secondary objective of this study is to determine whether the Being Present with Art intervention resulted in a longitudinal increase in connectedness for Session One participants.
This outcome is measured by connectedness scale we created for the purpose of this study (min = 1; max = 5) which consists of one question.
Higher scores indicate increased participant feelings of connectedness to the Yale community.
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Baseline, 4 weeks, 8 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pre vs. Post-Session Check-In: Investigating Stress
Periodo de tiempo: Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8
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Session One and Session Two participants each attended 4 consecutive weeks of the Being Present with Art programming.
The investigators wanted to know whether stress measures before vs. after any one of these four sessions resulted in decreased stress for both Session One and Session Two participants.
This was measured by asking students one question about how stressed they currently felt (min = 0; max = 4).
Higher scores indicate increased participant stress.
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Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8
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Pre vs. Post-Session Check-In: Investigating Mindfulness
Periodo de tiempo: Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8
|
Session One and Session Two participants each attended 4 consecutive weeks of the Being Present with Art programming.
The investigators wanted to know whether mindfulness measures before vs. after any one of these four sessions resulted in increased mindfulness for both Session One and Session Two participants.
This was measured by asking students one question about how aware of the present moment they currently felt (min = 0; max = 4).
Higher scores indicate increased mindful awareness.
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Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8
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Pre vs. Post-Session Check-In: Investigating Connectedness
Periodo de tiempo: Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8
|
Session One and Session Two participants each attended 4 consecutive weeks of the Being Present with Art programming.
The investigators wanted to know whether connectedness measures before vs. after any one of these four sessions resulted in increased connectedness for both Session One and Session Two participants.
This was measured by asking students one question about how connected to the Yale community they currently felt (min = 0; max = 4).
Higher scores indicate increased feelings of connectedness.
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Session One: Week 1, Week 2, Week 3, Week 4; Session Two: Week 5, Week 6, Week 7, Week 8
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Laurie Santos, Yale University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 2000028825
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Art Pedagogy and Mindfulness
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