Nature, HumanNCT05228704
Study on the Influence of Forest Therapy on Healing Experience in Botanical Gardens.
A study testing activities in the Botanical Garden or in urban in people with Nature, Human, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Nature, Human
- What is being tested?
- activities in the Botanical Garden or in urban
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Apr 2021to 26 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Nature, Human
- Being tested
- activities in the Botanical Garden or in urban
- Keywords
- Forest therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activities in the Botanical Garden or in urbanBehavioural
activities in the Taipei Botanical Garden or in Urban
| Study group | Role | What they receive |
|---|---|---|
| activities in the Botanical Garden or Urban | Experimental | experiment group is activities in the Botanical Garden, and the control group is activities in urban Receives: Behavioral: activities in the Botanical Garden or in urban |
| Cross-over design | Other | 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. Receives: Behavioral: activities in the Botanical Garden or in urban |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire: BPOMS (1st)
Change from baseline Brief Profile of Mood States at first intervention
Measured: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
questionnaire: BPOMS (2nd)
Change from Brief Profile of Mood States at second intervention after 7-day-washout period \& cross-over
Measured: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
questionnaire: BAI (1st)
Change from baseline The Beck Anxiety Inventory at first intervention
Measured: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
questionnaire: BAI (2nd)
Change from The Beck Anxiety Inventory at second intervention after 7-day-washout
Measured: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
questionnaire: BDI-II (1st)
Change from baseline The Beck Depression Inventory II at first intervention
Measured: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
questionnaire: BDI-II (2nd)
Change from The Beck Depression Inventory II at second intervention after 7-day-washout
Measured: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
questionnaire: BSRS-V (1st)
Change from baseline Brief Symptom Rating Scale V at first intervention
Measured: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
questionnaire: BSRS-V (2nd)
Change from Brief Symptom Rating Scale V at second intervention after 7-day-washout
Measured: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
physiological indicator: alpha-amylase activity in salivary (1st)
Change from baseline alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at first intervention
Measured: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
physiological indicator: alpha-amylase activity in salivary (2nd)
Change from alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at second intervention after 7-day-washout
Measured: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
physiological indicator: HRV (Heart Rate Variability) (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
Measured: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
physiological indicator: HRV (Heart Rate Variability) (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
Measured: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
physiological indicator: blood pressures (systolic and diastolic) (1st)
Change from baseline blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at first intervention
Measured: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)
physiological indicator: blood pressures (systolic and diastolic) (2nd)
Change from blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at second intervention after 7-day-washout
Measured: pre-intervention(2nd) → 2 hours intervention → immediately after the intervention(2nd)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start27 Apr 2021
- Primary completion27 Apr 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nature, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Chung-Hua Hsu, Taipei City Hospital
- Investigators
- Chung-Hua Hsu, Study director, Branch of Chinese Medicine, Taipei City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228704
- Sponsor's protocol ID
- TCHIRB-11002014
- Status last verified
- Jan 2022
- First submitted
- 8 Dec 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Influence of Forest Therapy on Healing Experience in Botanical Gardens.
- ClinicalTrials.gov ID
- NCT05228704
- Acronym / sponsor ID
- TCHIRB-11002014
- Conditions
- Nature, Human
- Keywords
- Forest therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| activities in the Botanical Garden or Urban | Experimental | Behavioral: activities in the Botanical Garden or in urbanexperiment group is activities in the Botanical Garden, and the control group is activities in urban |
| Cross-over design | Other | Behavioral: activities in the Botanical Garden or in urbanThe 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activities in the Botanical Garden or in urbanactivities in the Taipei Botanical Garden or in Urban | Behavioural | Cross-over design, activities in the Botanical Garden or Urban |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
Related trials for Nature, Human
Recruiting
Nurture by Nature Feasibility Study
Nature, Human, Pediatric ALL
Active, not recruitingObservational study
Skin Imaging With Technologies in Development
Pigmented Skin Lesion of Uncertain Nature
Not yet recruiting
Mystical Experiences Without Psychedelics and How Integration Improves Well-Being in Adults
Healthy Adult Participants
Recruiting
Transfer of Microorganisms Between Green Areas and Humans
Microbial Colonization
Recruiting
Nationwide Research on the Rewilding of Kindergarten Yards
Microbial Colonization, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-Hua Hsu study director
Branch of Chinese Medicine, Taipei City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing activities in the Botanical Garden or in urban in people with Nature, Human, run by Taipei City Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
questionnaire: BPOMS (1st) (time frame: baseline, pre-intervention(1st) → 2 hours intervention → immediately after the intervention(1st)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.