- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05316597
Do Terpenes Play a Role in the Stress-reducing Effects of a Forest Bathing Intervention?
Study Overview
Status
Intervention / Treatment
Detailed Description
The investigators will use an individual-level crossover design in which each session is conducted independently and on different days. Participants will be outfitted with a powered air purifying respirator (PAPR) to selectively modulate exposure to a natural suite of forest-derived volatile organic compounds (VOCs) while present in forest environments. Each participant will undergo two forest bathing sessions, one in which VOCs are not filtered (treatment condition), and one in which they are filtered (control condition). Sessions will be separated by a 7-day washout period for each participant, and order will be counterbalanced. The investigators will estimate the average effect of treatment over 40 distinct treatment days against 40 distinct control/filtered days. The power and sample size calculations (N = 40) were determined using previous nature exposure studies of similar cross-over design. The study is adequately powered assuming the conventional targets of α = 0.05 and β = 0.80 with a 10% anticipated dropout rate, and including temperature, wind, and light variability during treatment days.
The specific aim of this project is to 1) assess whether VOC inhalation regulates increases in the high frequency (HF) (ms2) component of heart rate variability (HRV) as the primary outcome (with decreases in blood pressure, heart rate, self-reported stress, and levels of inflammatory cytokines in serum included as secondary outcomes); and 1a) assess the degree of association of absorbed dose of seven forest-derived VOCs in serum (i.e., α-pinene, β-pinene, β-myrcene, ∆ 3-carene, d-limonene, β- caryophyllene, α-humulene) with these outcomes.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gregory Bratman, PhD
- Phone Number: 206-543-7591
- Email: bratman@uw.edu
Study Locations
-
-
Washington
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Eatonville, Washington, United States, 98328
- Recruiting
- Pack Forest
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years and older
- Non-smoker
- Physically capable of walking for approximately 15-20 min from the study vehicle to the clinic and experimental locations.
Exclusion Criteria:
- Pregnancy
- Current or prior diagnosis of neurologic, hypertensive, psychiatric, respiratory disorder, or anosmia/hyposmia
- Some types of medication.
- Olfactory sensitivity threshold (assessed via UPSIT® test kit (Sensonics International, Haddon Heights, NJ)
- Positive COVID-19 test
At enrollment, participants will complete a baseline survey on demographics, personality traits, and regular nature contact and perceptions. Study staff will also use the clinically-validated UPSIT® test kit (Sensonics International, Haddon Heights, NJ) to evaluate olfactory sensitivity and identify/exclude participants with undiagnosed smell loss.
Study staff will work with participants to schedule their forest bathing sessions and review instructions on how to prepare (e.g., by avoiding alcohol, marijuana, and certain foods, drinks, and household cleaning products with high terpene concentrations 24 hrs before their session).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Terpenes On
Forest bathing intervention with no filtration of terpenes from inhaled air ("terpenes on")
|
Participants will be seated in a forest environment for an hour-long exposure to the forest
|
Active Comparator: Terpenes Off
Forest bathing intervention with filtration of terpenes from inhaled air ("terpenes off")
|
Participants will be seated in a forest environment for an hour-long exposure to the forest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the HF (ms2) component of HRV
Time Frame: up to 1 hour before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Assess whether VOC inhalation regulates psychophysiological outcomes of the terpenes-on vs. terpenes-off sessions.
|
up to 1 hour before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure (systolic and diastolic in mmHg)
Time Frame: up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Assessed using mobile physiology equipment
|
up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Heart rate (beats per minute)
Time Frame: up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Assessed using mobile physiology equipment
|
up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Skin conductance (μS)
Time Frame: up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Assessed using mobile physiology equipment
|
up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Self-reported affect
Time Frame: up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Assessed using the shortened Positive and Negative Affect Schedule (PANAS) and/or Profile of Mood States (POMS)
|
up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Self-reported anxiety
Time Frame: up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Assessed using the shortened State-Trait Anxiety Inventory (STAI)
|
up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Self-reported stress
Time Frame: up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Assessed using Perceived Stress Scale 4 (PSS-4)
|
up to 2.5 hours before the forest bathing session, during the forest bathing session (1 hr), and up to 1 hour following the forest bathing session (1hr).
|
Levels of inflammatory cytokines (CRP, TNF-alpha, and IL-6 in μg/mL)
Time Frame: Up to 1 hour before the forest bathing session (1 hr); up to 1 hour after the forest bathing session (1 hr)
|
Assessed using blood serum collected via standard clinical methods
|
Up to 1 hour before the forest bathing session (1 hr); up to 1 hour after the forest bathing session (1 hr)
|
Levels of cortisol in serum (μg/mL)
Time Frame: Up to 1 hour before the forest bathing session (1 hr); up to 1 hour after the forest bathing session (1 hr)
|
Assessed using blood serum collected via standard clinical methods
|
Up to 1 hour before the forest bathing session (1 hr); up to 1 hour after the forest bathing session (1 hr)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Degree of association of absorbed dose of VOCs in serum (μg/mL)
Time Frame: Up to 1 hour before the forest bathing session (1 hr); up to 1 hour after the forest bathing session (1 hr)
|
Assess the degree of association of absorbed dose of seven forest-derived VOCs in serum (i.e., α-pinene, β-pinene, β-myrcene, ∆ 3- carene, d-limonene, β-caryophyllene, α-humulene) with primary and secondary outcomes.
|
Up to 1 hour before the forest bathing session (1 hr); up to 1 hour after the forest bathing session (1 hr)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gregory Bratman, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00013134
- R21AT011242 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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