- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05228704
Study on the Influence of Forest Therapy on Healing Experience in Botanical Gardens.
26. januar 2022 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
42
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Taipei, Taiwan, 10845
- Taipei City Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 35 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Andet: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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questionnaire: BPOMS (1st)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
|
|
questionnaire: BDI-II (2nd)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Chung-Hua Hsu, Branch of Chinese Medicine, Taipei City Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. april 2021
Primær færdiggørelse (Faktiske)
27. april 2021
Studieafslutning (Faktiske)
26. oktober 2021
Datoer for studieregistrering
Først indsendt
8. december 2021
Først indsendt, der opfyldte QC-kriterier
26. januar 2022
Først opslået (Faktiske)
8. februar 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. februar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. januar 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- TCHIRB-11002014
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