- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05228704
Study on the Influence of Forest Therapy on Healing Experience in Botanical Gardens.
26. ledna 2022 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
42
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Taipei, Tchaj-wan, 10845
- Taipei City Hospital
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
20 let až 35 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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)
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Jiný: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
questionnaire: BPOMS (1st)
Časové okno: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
Change from baseline Brief Profile of Mood States at first intervention
|
baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
|
questionnaire: BPOMS (2nd)
Časové okno: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
Change from Brief Profile of Mood States at second intervention after 7-day-washout period & cross-over
|
pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
|
|
questionnaire: BAI (1st)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
|
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questionnaire: BSRS-V (2nd)
Časové okno: 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)
Časové okno: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
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)
Časové okno: 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)
|
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physiological indicator: HRV (Heart Rate Variability) (1st)
Časové okno: 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)
Časové okno: 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
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pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
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physiological indicator: blood pressures (systolic and diastolic) (1st)
Časové okno: 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
|
baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
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physiological indicator: blood pressures (systolic and diastolic) (2nd)
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: Chung-Hua Hsu, Branch of Chinese Medicine, Taipei City Hospital
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
27. dubna 2021
Primární dokončení (Aktuální)
27. dubna 2021
Dokončení studie (Aktuální)
26. října 2021
Termíny zápisu do studia
První předloženo
8. prosince 2021
První předloženo, které splnilo kritéria kontroly kvality
26. ledna 2022
První zveřejněno (Aktuální)
8. února 2022
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. února 2022
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
26. ledna 2022
Naposledy ověřeno
1. ledna 2022
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- TCHIRB-11002014
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