- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05228704
Study on the Influence of Forest Therapy on Healing Experience in Botanical Gardens.
January 26, 2022 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 10845
- Taipei City Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: activities in the Botanical Garden or Urban
experiment group is activities in the Botanical Garden, and the control group is activities in urban
|
activities in the Taipei Botanical Garden or in Urban
|
Other: 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.
|
activities in the Taipei Botanical Garden or in Urban
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
questionnaire: BPOMS (1st)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
|
physiological indicator: alpha-amylase activity in salivary (2nd)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
|
physiological indicator: blood pressures (systolic and diastolic) (1st)
Time Frame: 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)
Time Frame: 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Chung-Hua Hsu, Branch of Chinese Medicine, Taipei City Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 27, 2021
Primary Completion (Actual)
April 27, 2021
Study Completion (Actual)
October 26, 2021
Study Registration Dates
First Submitted
December 8, 2021
First Submitted That Met QC Criteria
January 26, 2022
First Posted (Actual)
February 8, 2022
Study Record Updates
Last Update Posted (Actual)
February 8, 2022
Last Update Submitted That Met QC Criteria
January 26, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TCHIRB-11002014
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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