- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05228704
Study on the Influence of Forest Therapy on Healing Experience in Botanical Gardens.
26 de enero de 2022 actualizado por: Chung-Hua Hsu, Taipei City Hospital
The forest healing system is an important topic of alternative therapy in recent years.
To study the influence of Forest therapy, the establishment of a pilot experimental model system in which both environmental factors and type of activity are necessary.
Therefore, a system based on the Taipei Botanical Garden was introduced by this study.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The forest healing system is an important topic of alternative therapy in recent years.
Forest therapy began in 1989 when the psychology professor Kaplan put forward the "Attention Restoration Theory(ART)".
Awareness has a positive benefit.
To study the influence of Forest therapy, the establishment of a pilot experimental model system in which both environmental factors and type of activity are controlled can greatly reduce the errors caused by the site and the content of the activity.
Therefore, a randomized controlled crossover experiment based on the Taipei Botanical Garden was introduced by this study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
42
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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Taipei, Taiwán, 10845
- Taipei City Hospital
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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
20 años a 35 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- 20-35 years old youth (not limited to men and women)
- Those who have the ability and physical strength to walk for more than 120 minutes
- Subjects must voluntarily join the study
Exclusion Criteria:
- People who smoke or chew betel nuts
- People who have the habit of drinking (drinking more than five standard glasses in any situation)
- Drug addiction (including narcotic drugs and non-narcotics) habitual
- Those who have taken psychosomatic drugs in the past 30 days
- Participating in another clinical trial at the same time, or in the follow-up period of an interventional trial
- Those diagnosed with major injuries
- Women who are currently pregnant or breastfeeding
- Conditions where other subjects cannot cooperate (for example: unable to participate after random assignment, and not signing the subject's consent form)
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: activities in the Botanical Garden or Urban
experiment group is activities in the Botanical Garden, and the control group is activities in urban
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activities in the Taipei Botanical Garden or in Urban
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Otro: Cross-over design
The participants are randomized divided into in two groups following by the experiment which is designed by two consecutive times at one week intervals, and the experimental activities and the control activities are staggered.
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activities in the Taipei Botanical Garden or in Urban
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
questionnaire: BPOMS (1st)
Periodo de tiempo: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
Change from baseline Brief Profile of Mood States at first intervention
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baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
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questionnaire: BPOMS (2nd)
Periodo de tiempo: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
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Change from Brief Profile of Mood States at second intervention after 7-day-washout period & cross-over
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pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
|
questionnaire: BAI (1st)
Periodo de tiempo: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
Change from baseline The Beck Anxiety Inventory at first intervention
|
baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
|
questionnaire: BAI (2nd)
Periodo de tiempo: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
Change from The Beck Anxiety Inventory at second intervention after 7-day-washout
|
pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
|
questionnaire: BDI-II (1st)
Periodo de tiempo: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
Change from baseline The Beck Depression Inventory II at first intervention
|
baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
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questionnaire: BDI-II (2nd)
Periodo de tiempo: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
Change from The Beck Depression Inventory II at second intervention after 7-day-washout
|
pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
|
questionnaire: BSRS-V (1st)
Periodo de tiempo: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
Change from baseline Brief Symptom Rating Scale V at first intervention
|
baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
|
questionnaire: BSRS-V (2nd)
Periodo de tiempo: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
Change from Brief Symptom Rating Scale V at second intervention after 7-day-washout
|
pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
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physiological indicator: alpha-amylase activity in salivary (1st)
Periodo de tiempo: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
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Change from baseline alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at first intervention
|
baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
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physiological indicator: alpha-amylase activity in salivary (2nd)
Periodo de tiempo: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
Change from alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at second intervention after 7-day-washout
|
pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
|
physiological indicator: HRV (Heart Rate Variability) (1st)
Periodo de tiempo: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
Change from baseline HRV by using wrist monitors (ANSWatch®) to measure heart rate, heart rate variability (related to activities of the autonomic nervous system ANS), irregular heartbeats (IRRHB), and 5-minute continuous pulse wave at first intervention
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baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
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physiological indicator: HRV (Heart Rate Variability) (2nd)
Periodo de tiempo: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
Change from HRV by using wrist monitors (ANSWatch®) to measure heart rate, heart rate variability (related to activities of the autonomic nervous system ANS), irregular heartbeats (IRRHB), and 5-minute continuous pulse wave at second intervention after 7-day-washout
|
pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
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physiological indicator: blood pressures (systolic and diastolic) (1st)
Periodo de tiempo: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
Change from baseline blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at first intervention
|
baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
|
physiological indicator: blood pressures (systolic and diastolic) (2nd)
Periodo de tiempo: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
Change from blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at second intervention after 7-day-washout
|
pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Chung-Hua Hsu, Branch of Chinese Medicine, Taipei City Hospital
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)
27 de abril de 2021
Finalización primaria (Actual)
27 de abril de 2021
Finalización del estudio (Actual)
26 de octubre de 2021
Fechas de registro del estudio
Enviado por primera vez
8 de diciembre de 2021
Primero enviado que cumplió con los criterios de control de calidad
26 de enero de 2022
Publicado por primera vez (Actual)
8 de febrero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de febrero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
26 de enero de 2022
Última verificación
1 de enero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- TCHIRB-11002014
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. .