- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05228704
Study on the Influence of Forest Therapy on Healing Experience in Botanical Gardens.
26. Januar 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
42
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
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Taipei, Taiwan, 10845
- Taipei City Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre bis 35 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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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Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
questionnaire: BPOMS (1st)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
|
|
physiological indicator: alpha-amylase activity in salivary (1st)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
|
|
physiological indicator: HRV (Heart Rate Variability) (2nd)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Chung-Hua Hsu, Branch of Chinese Medicine, Taipei City Hospital
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
27. April 2021
Primärer Abschluss (Tatsächlich)
27. April 2021
Studienabschluss (Tatsächlich)
26. Oktober 2021
Studienanmeldedaten
Zuerst eingereicht
8. Dezember 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. Januar 2022
Zuerst gepostet (Tatsächlich)
8. Februar 2022
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Februar 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Januar 2022
Zuletzt verifiziert
1. Januar 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- TCHIRB-11002014
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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