NCT05228704

Brief 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. Therefore, a system based on the Taipei Botanical Garden was introduced by this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

Same day

First QC Date

December 8, 2021

Last Update Submit

January 26, 2022

Conditions

Keywords

Forest therapy

Outcome Measures

Primary Outcomes (14)

  • questionnaire: BPOMS (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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

    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)

Study Arms (2)

activities in the Botanical Garden or Urban

EXPERIMENTAL

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

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.

Behavioral: activities in the Botanical Garden or in urban

Interventions

activities in the Taipei Botanical Garden or in Urban

Cross-over designactivities in the Botanical Garden or Urban

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei city hospital

Taipei, 10845, Taiwan

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Chung-Hua Hsu

    Branch of Chinese Medicine, Taipei City Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 8, 2021

First Posted

February 8, 2022

Study Start

April 27, 2021

Primary Completion

April 27, 2021

Study Completion

October 26, 2021

Last Updated

February 8, 2022

Record last verified: 2022-01

Locations