- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07568301
Nature in Harmony: Music and Nature-based Self-care for Individuals With Acquired Brain Injuries and Their Care Partners
The goal of this pilot study is to determine the initial impact on wellbeing for clients with acquired brain injury and their care partner after engaging in a nature & music-based program facilitated by occupational therapy and music therapy. The main questions it aims to answer are:
- Primary Question: What is the impact on wellbeing for clients with acquired brain injury and their care partner after engaging in a nature & music-based program facilitated by occupational therapy and music therapy?
Secondary Question: What is the feasibility of a four-session nature & music-based wellness program for clients with acquired brain injury and care partner dyads?
- Attendance
- Satisfaction
- Accessibility
- Carryover of Strategies
Participants will complete self-reported surveys before and after completing 4 sessions of a nature & music-based program facilitated by occupational therapy and music therapy.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15228
- Duquesne University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- All participants must be above the age of 18 to participate.
- Able to communicate in English
- A person with an ABI can include persons with a diagnosis of traumatic brain injury, stroke, aneurysm, brain infection, and/or brain cancer.
- A care partner is broadly defined as a social support person who has been identified as a family member or friend of the person with the acquired brain injury.
- Capacity for consent - Person must be their own medical power of attorney
- Capacity for Self-Reflection (have a score of 23/35 on the MOCA or have a 5/6 on the Design Memory Test sub test of Cognition and Language Quick Test)
Exclusion Criteria:
- Self-reported severe-to profound hearing loss with the use of hearing aid(s)
- Cannot communicate in English
- Have a diagnosis of a progressive neurological disorder, such as Amyotrophic lateral sclerosis, Parkinson's disease, Dementia, Multiple Sclerosis
- Have a severe aphasia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- 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: Nature In Harmony
The Nature in Harmony program involves four in-person sessions held at Duquesne University's campus using the outdoor pavilion and community garden with the final session occurring at Frick Park at their Environmental Center located in Pittsburgh, PA, between May and June of 2026.
Each session will have a minimum of two principal investigators to lead the activities.
Graduate assistants will be at each session to provide additional hands-on support for safety, mobility, and participant engagement.
Participants will be instructed to complete carryover activities between sessions: one to be completed together dyadically (person with ABI & care partner) and one to be completed individually.
Dyads will reflect on the experience in their activity journal and share and the beginning of sessions 2-4.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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EUROHIS-QOL 8-item index
Periodo de tiempo: First session to end of program approximately 4 weeks.
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EUROHIS-QOL 8 is a standardized assessment of general quality of life that assesses four domains of QOL: physical, psychological, social, and environmental.
This assessment has been validated for persons with traumatic brain injury (Balalla et al., 2019).
This is 5-point scale from "not at all" to "completely."
A high total point value indicates a better quality of life rating.
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First session to end of program approximately 4 weeks.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Connor-Davidson Resilience Scale
Periodo de tiempo: First session to end of program approximately 4 weeks.
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The 10-item Connor-Davidson Resilience Scale will be administered as a secondary outcome to determine if any impacts are seen after this brief program because of participation.
This measure has been used with persons post-traumatic brain injury, stroke, and caregivers.
Rating scale goes from 0-4 with higher total scores indicating better resilence.
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First session to end of program approximately 4 weeks.
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Dyadic Relationship Scale
Periodo de tiempo: First day to end of program approximately 4 weeks
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The 10-item Dyadic Relationship Scale will be administered as a secondary outcome to examine any changes in both positive and negative interactions between individuals with ABI and their care partners after this program (Sebern & Whitlatch, 2007).
This is a four point scale with a higher score indicating more negative dyad experiences.
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First day to end of program approximately 4 weeks
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Client Satisfaction Questionnaire (CSQ-8)
Periodo de tiempo: Last session, approximately 4 weeks after first session
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This measure uses eight questions on a four point Likert-scale strongly agree to strongly disagree to assess participants' overall satisfaction with the program with a maximum score of 32 (Attkisson & Greenfield, 2004).
The average score for the group on the CSQ-8 is at least 24.
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Last session, approximately 4 weeks after first session
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Attendance
Periodo de tiempo: Every week for 4 weeks.
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Session attendance will be tracked at every session throughout the program as either present "1" or absent "0".
Participants who attend all sessions will have a total of 4.
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Every week for 4 weeks.
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Accessibility of the strategies
Periodo de tiempo: Every week of the program for four weeks.
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4-point Likert scale survey will be used to document participants' interest in using the covered strategies in the sessions.
Items will not be totaled and scales vary by question.
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Every week of the program for four weeks.
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Carryover of the strategies
Periodo de tiempo: Weekly journal entries for weeks 2,3, and 4.
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A self-reported journal includes date, the name of the activity, length, and personnels will be provided for documenting the carryover activities outside of the session time.
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Weekly journal entries for weeks 2,3, and 4.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- 2025/11/22
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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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