- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04722367
Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Connecticut
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New Haven, Connecticut, Spojené státy, 06520
- Yale University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in stress from Impact of Being Present with Art Intervention
Časové okno: 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
Časové okno: 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
|
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Change in Connectedness from Impact of Being Present with Art Intervention
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Longitudinal Impact of Being Present with Art Intervention on Stress
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pre vs. Post-Session Check-In: Investigating Stress
Časové okno: 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
Časové okno: 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 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Laurie Santos, Yale University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 2000028825
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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