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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: activities in the Botanical Garden or Urban
experiment group is activities in the Botanical Garden, and the control group is activities in urban
Behavioral: activities in the Botanical Garden or 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.
Behavioral: activities in the Botanical Garden or in urban
activities in the Taipei Botanical Garden or in Urban

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 26, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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