A Feasibility Study to Determine Whether the Botanical Garden Become a Region of Forest Therapy for Cancer Survivors

Depression Clinical Trial

Official title:

A Feasibility Study to Determine Whether the Botanical Garden Become a Region of Forest Therapy for Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06001723
• Other study ID #: TCHIRB-11104010
• Status: Completed
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: January 20, 2023

Study information

• Verified date: August 2023
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The forest healing system is an important topic of alternative therapy in recent years. To investigates forest therapy's effectiveness in alleviating negative emotions among post-cancer patients. It compares therapy outcomes at Taipei Botanical Garden and Fushan Botanical Garden. Utilizing a pretest-posttest experimental design, a two-hour guided forest healing activity serves as the intervention method. Data collection involves instrumental tests and saliva samples.

Description:

Introduction:

Cancer's global impact persists, ranking among the top three causes of death in Taiwan. Despite improved survival rates after cancer surgery, negative emotions among patients remain a challenge. Post-cancer depression adversely affects treatment outcomes and overall quality of life. Forest therapy, a natural healing approach, has gained attention for its potential to reduce stress, mitigate negative emotions, and enhance well-being.

Objectives:

This study investigates forest therapy's effectiveness in alleviating negative emotions among post-cancer patients. It compares therapy outcomes at Taipei Botanical Garden and Fushan Botanical Garden. Additionally, the study explores the lasting emotional benefits of forest therapy.

Methods:

Utilizing a pretest-posttest experimental design, this study is conducted at the Botanical Garden in Fushan, Taipei. Participants are cancer patients who are six months post-treatment. A two-hour guided forest healing activity serves as the intervention method. Data collection involves instrumental tests and saliva samples. A comparable location adjacent to Taipei Botanical Garden, excluding urban areas, is selected for comparison activities. Portable heart rhythm monitors track data, and saliva samples are analyzed for salivary α-amylase enzyme kinetics and cortisol concentrations. The study employs questionnaires including the Profile of Mood States 2nd Edition-Adult short (POMS2-A short), Beck Depression Inventory-Second edition (BDI-II), Beck Anxiety Inventory (BAI), and the abbreviated Taiwan version of the World Health Organization Quality of Life-Brief (WHOQOL-BREF).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Years to 82 Years

Eligibility

Inclusion Criteria:

• Over 20 year-old

• Cancer patients finished cancer treatments more than 6 months (regardless hormone therapy)

• Voluntary attendance

Exclusion Criteria:

• People who unable to walk for at least 120 minutes

• People who still smoking, chewing betel nut or drinking alcohol (over five standard cups in any situation)

• People who addicted to medicine

• People who attend another clinical trial at the same time or in the follow-up period of an interventional trial

• Pregnant women or breast feeding

• Other conditions that participants unable to cooperate with

Related Conditions & MeSH terms

• Cancer
• Depression
• Mental Disorders
• Mental Health Disorder
• Neoplasms

Intervention

Behavioral:
• Forest Therapy
Forest healing activities are guided by professionals, allowing participants to engage in a two-hour sensory experience within the forest environment. This includes activities such as stacking leaves and stones, closing their eyes to listen to sounds, engaging in physical stretches, blindfolded tree identification, connecting with tree companions, creating earth mandalas, and partaking in tea ceremonies and sharing insights.

Locations

Country	Name	City	State
Taiwan	Taipei city hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei City Hospital	Taiwan Forestry Research Institute

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	questionnaire: POMS2-A short (Fushan botanical garden)	Change of the Profile of Mood States 2nd Edition-Adult short at Fushan botanical garden	per-test ? 2 hours intervention at Fushan botanical garden ? post-test immediately after the intervention
Primary	questionnaire: POMS2-A short (Taipei botanical garden)	Change of the Profile of Mood States 2nd Edition-Adult short at Taipei botanical garden	per-test ? 2 hours intervention at Taipei botanical garden ? post-test immediately after the intervention
Primary	questionnaire: POMS2-A short (urban region)	Change of the Profile of Mood States 2nd Edition-Adult short at urban region	per-test ? 2 hours intervention at urban region ? post-test immediately after the intervention
Primary	questionnaire: BAI (Fushan botanical garden)	Change of The Beck Anxiety Inventory at Fushan botanical garden	per-test ? 2 hours intervention at Fushan botanical garden ? post-test immediately after the intervention
Primary	questionnaire: BAI (Taipei botanical garden)	Change of The Beck Anxiety Inventory at Taipei botanical garden	per-test ? 2 hours intervention at Taipei botanical garden ? post-test immediately after the intervention
Primary	questionnaire: BAI (urban region)	Change of The Beck Anxiety Inventory at urban region	per-test ? 2 hours intervention at urban region ? post-test immediately after the intervention
Primary	questionnaire: BDI-II (Fushan botanical garden)	Change of The Beck Depression Inventory II at Fushan botanical garden	per-test ? 2 hours intervention at Fushan botanical garden ? post-test immediately after the intervention
Primary	questionnaire: BDI-II (Taipei botanical garden)	Change of baseline The Beck Depression Inventory II at Taipei botanical garden	per-test ? 2 hours intervention at Taipei botanical garden ? post-test immediately after the intervention
Primary	questionnaire: BDI-II (urban region)	Change of baseline The Beck Depression Inventory II at urban region	per-test ? 2 hours intervention at urban region ? post-test immediately after the intervention
Primary	questionnaire: WHOQOL-BREF (Fushan botanical garden)	Change of World Health Organization Quality of Life-Brief (Taiwan version) at Fushan botanical garden	per-test ? 2 hours intervention at Fushan botanical garden ? post-test immediately after the intervention
Primary	questionnaire: WHOQOL-BREF (Taipei botanical garden)	Change of World Health Organization Quality of Life-Brief (Taiwan version) at Taipei botanical garden	per-test ? 2 hours intervention at Taipei botanical garden ? post-test immediately after the intervention
Primary	questionnaire: WHOQOL-BREF (urban region)	Change of World Health Organization Quality of Life-Brief (Taiwan version) at urban region	per-test ? 2 hours intervention at urban region ? post-test immediately after the intervention
Primary	physiological indicator: alpha-amylase activity in salivary (Fushan botanical garden)	Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at Fushan botanical garden	per-test ? 2 hours intervention at Fushan botanical garden ? post-test immediately after the intervention
Primary	physiological indicator: alpha-amylase activity in salivary (Taipei botanical garden)	Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at Taipei botanical garden	per-test ? 2 hours intervention at Taipei botanical garden ? post-test immediately after the intervention
Primary	physiological indicator: alpha-amylase activity in salivary (urban region)	Change of alpha-amylase activity in salivary by using commercial kits (Salimetrics®) at urban region	per-test ? 2 hours intervention at urban region ? post-test immediately after the intervention
Primary	physiological indicator: cortisol concentration in salivary (Fushan botanical garden)	Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at Fushan botanical garden	per-test ? 2 hours intervention at Fushan botanical garden ? post-test immediately after the intervention
Primary	physiological indicator: cortisol concentration in salivary (Taipei botanical garden)	Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at Taipei botanical garden	per-test ? 2 hours intervention at Taipei botanical garden ? post-test immediately after the intervention
Primary	physiological indicator: cortisol concentration in salivary (urban region)	Change of cortisol concentration in salivary by using commercial kits (Salimetrics®) at urban region	per-test ? 2 hours intervention at urban region ? post-test immediately after the intervention
Primary	physiological indicator: HRV (Heart Rate Variability) (Fushan botanical garden)	Change of 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 Fushan botanical garden	per-test ? 2 hours intervention at Fushan botanical garden ? post-test immediately after the intervention
Primary	physiological indicator: HRV (Heart Rate Variability) (Taipei botanical garden)	Change of 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 Taipei botanical garden	per-test ? 2 hours intervention at Taipei botanical garden ? post-test immediately after the intervention
Primary	physiological indicator: HRV (Heart Rate Variability) (urban region)	Change of 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 urban region	per-test ? 2 hours intervention at urban region ? post-test immediately after the intervention
Primary	physiological indicator: blood pressures (systolic and diastolic) (Fushan botanical garden)	Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at Fushan botanical garden	per-test ? 2 hours intervention at Fushan botanical garden ? post-test immediately after the intervention
Primary	physiological indicator: blood pressures (systolic and diastolic) (Taipei botanical garden)	Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at Taipei botanical garden	per-test ? 2 hours intervention at Taipei botanical garden ? post-test immediately after the intervention
Primary	physiological indicator: blood pressures (systolic and diastolic) (urban region)	Change of blood pressures by using wrist monitors (ANSWatch®) to measure blood pressures (systolic and diastolic) at urban region	per-test ? 2 hours intervention at urban region ? post-test immediately after the intervention