- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05228704
Study on the Influence of Forest Therapy on Healing Experience in Botanical Gardens.
26 stycznia 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Interwencyjne
Zapisy (Rzeczywisty)
42
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Taipei, Tajwan, 10845
- Taipei City Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
20 lat do 35 lat (Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Inny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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questionnaire: BPOMS (1st)
Ramy czasowe: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
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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)
Ramy czasowe: 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)
Ramy czasowe: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
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)
Ramy czasowe: 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)
|
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questionnaire: BDI-II (1st)
Ramy czasowe: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
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Change from baseline The Beck Depression Inventory II at first intervention
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baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
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questionnaire: BDI-II (2nd)
Ramy czasowe: 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)
Ramy czasowe: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
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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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
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pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
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physiological indicator: HRV (Heart Rate Variability) (1st)
Ramy czasowe: 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)
Ramy czasowe: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
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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)
Ramy czasowe: 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)
Ramy czasowe: 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)
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: Chung-Hua Hsu, Branch of Chinese Medicine, Taipei City Hospital
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
27 kwietnia 2021
Zakończenie podstawowe (Rzeczywisty)
27 kwietnia 2021
Ukończenie studiów (Rzeczywisty)
26 października 2021
Daty rejestracji na studia
Pierwszy przesłany
8 grudnia 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
26 stycznia 2022
Pierwszy wysłany (Rzeczywisty)
8 lutego 2022
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
8 lutego 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
26 stycznia 2022
Ostatnia weryfikacja
1 stycznia 2022
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- TCHIRB-11002014
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .