- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05228704
Study on the Influence of Forest Therapy on Healing Experience in Botanical Gardens.
26 de janeiro de 2022 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
42
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Taipei, Taiwan, 10845
- Taipei City Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
20 anos a 35 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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)
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Outro: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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questionnaire: BPOMS (1st)
Prazo: 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)
Prazo: 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)
|
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questionnaire: BAI (1st)
Prazo: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
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Change from baseline The Beck Anxiety Inventory at first intervention
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baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
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questionnaire: BAI (2nd)
Prazo: 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)
Prazo: 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)
Prazo: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
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Change from The Beck Depression Inventory II at second intervention after 7-day-washout
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pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
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questionnaire: BSRS-V (1st)
Prazo: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
Change from baseline Brief Symptom Rating Scale V at first intervention
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baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
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questionnaire: BSRS-V (2nd)
Prazo: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
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Change from Brief Symptom Rating Scale V at second intervention after 7-day-washout
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pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
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physiological indicator: alpha-amylase activity in salivary (1st)
Prazo: 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
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baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
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physiological indicator: alpha-amylase activity in salivary (2nd)
Prazo: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
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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)
|
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physiological indicator: HRV (Heart Rate Variability) (1st)
Prazo: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
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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)
Prazo: 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)
Prazo: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
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Change from baseline blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) 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: blood pressures (systolic and diastolic) (2nd)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Chung-Hua Hsu, Branch of Chinese Medicine, Taipei City Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
27 de abril de 2021
Conclusão Primária (Real)
27 de abril de 2021
Conclusão do estudo (Real)
26 de outubro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
8 de dezembro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de janeiro de 2022
Primeira postagem (Real)
8 de fevereiro de 2022
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de fevereiro de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de janeiro de 2022
Última verificação
1 de janeiro de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- TCHIRB-11002014
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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