- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07581639
Comparison of Live and Virtual Music-based Interventions in Mitigating Stress
12 de mayo de 2026 actualizado por: University of Pennsylvania
Comparison of Live and Virtual Music-based Interventions in Mitigating Stress: A Pilot Study
The purpose of this study is to learn if virtual music therapy with active engagement components leads to the same benefits as traditional live music therapy in mitigating stress in older adults.
This study aims to compare live and virtual music interventions among older adults with cognitive impairment living in assisted living facilities.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
32
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
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Pennsylvania
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Berwyn, Pennsylvania, Estados Unidos, 19312
- Conestoga High School
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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
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Lives in included assisted living facility
- 65 years or older
- Able to provide informed consent
- Able to hear music
- Able to see a computer screen
- Able to speak
Exclusion Criteria:
- Does not live in included assisted living facility
- Younger than 65 years
- Unable to provide informed consent
- Unable to hear music
- Unable to see a computer screen
- Unable to speak
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Live music therapy
The live music intervention was presented in the activities room of each senior center and included a classical violin for the performer (a classically trained violinist with experience arranging and playing pop music), a second violin for participant engagement, and a computer speaker for digital sound output (Dell, Inc.).
The live music intervention sessions included multiple active engagement components, such as music adjustment (e.g., lowering the tempo, changing to an upbeat piece) to match participants' apparent mood, verbal interaction, physical engagement (e.g., encouraging dancing, on-beat clapping), and singing along.
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The live music intervention was presented in the activities room of each senior center and included a classical violin for the performer (a classically trained violinist with experience arranging and playing pop music), a second violin for participant engagement, and a computer speaker for digital sound output (Dell, Inc.).
The live music intervention sessions included multiple active engagement components, such as music adjustment (e.g., lowering the tempo, changing to an upbeat piece) to match participants' apparent mood, verbal interaction, physical engagement (e.g., encouraging dancing, on-beat clapping), and singing along.
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Experimental: Virtual music therapy
The virtual intervention followed identical procedures as the live intervention and involved similar active engagement components, with the music being delivered to the same cohort via video conference (Zoom Communications, Inc.).
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The virtual intervention followed identical procedures as the live intervention and involved similar active engagement components, with the music being delivered to the same cohort via video conference (Zoom Communications, Inc.).
In both live and virtual sessions, the performer showed identical levels of engagement and adjustment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Heart rate (HR)
Periodo de tiempo: Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)
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Registered nurses at each assisted living facility measured and recorded each participant's heart rate (HR) using an oxygen saturation monitor (Oxiline, Inc.).
The monitor was placed on each participants' finger and the heart rate was recorded for a 1-minute interval 15 minutes before and after each music-based session.
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Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)
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Systolic blood pressure
Periodo de tiempo: Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)
|
Systolic blood pressure was measured using a sphygmomanometer (Curaplex, Inc.) immediately after the heart rate measurement
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Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)
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|
Self-reported stress levels
Periodo de tiempo: Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)
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The self-reported stress survey was adapted and modified from Levenstein et al. (1993), with question wording modified to reduce the reading level.
The stress-assessment survey was condensed to a total of 10 questions, each rated on a 4-level Likert scale from strongly disagree (0) to strongly agree (3).
To maintain consistency, the rating on 4 items indicating lack of stress was reversed, so that 0 corresponded to 3 points.
The total score was calculated by adding the individual scores for each question (score range, 0 to 30, where a higher rating corresponds to greater stress).
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Baseline (15 minutes before the music intervention session) and follow-up (15 minutes after the music intervention session was completed)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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 (Actual)
1 de agosto de 2025
Finalización primaria (Actual)
27 de septiembre de 2025
Finalización del estudio (Actual)
27 de septiembre de 2025
Fechas de registro del estudio
Enviado por primera vez
27 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
5 de mayo de 2026
Publicado por primera vez (Actual)
12 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 01082025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Informed consent to share individual participant data was not obtained.
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. .