- 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 washout period of at least 8 days 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 six forest-derived VOCs (i.e., α-pinene, β-pinene, β-myrcene, Δ-3-carene, limonene, β- carophyllene) in serum with these outcomes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Eatonville, Washington, United States, 98328
- Pack Forest
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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 using PAPR with particle-only filter ("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 using PAPR with activated charcoal filter ("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 (ms^2) Component of HRV
Time Frame: At time point 2 (20 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assess whether VOC inhalation regulates psychophysiological outcomes of the terpenes-on vs. terpenes-off sessions. Ln High Frequency Heart Rate Variability at T2 (20 minutes into duration of exposure for each session) |
At time point 2 (20 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Baseline HF (ms^2) Component of HRV
Time Frame: At baseline (pre-exposure)
|
Assess whether VOC inhalation regulates psychophysiological outcomes of the terpenes-on vs. terpenes-off sessions. Ln High Frequency Heart Rate Variability at baseline. |
At baseline (pre-exposure)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood Pressure (Diastolic in mmHg)
Time Frame: At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assessed using mobile physiology equipment Diastolic blood pressure at T4 (60 minutes of exposure)
|
At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Beats Per Minute (BPM)
Time Frame: At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assessed using mobile physiology equipment BPM at time point 4 (60 minutes of exposure)
|
At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Skin Conductance (μS)
Time Frame: At time point 2 (20 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assessed using mobile physiology equipment Skin conductance levels at time point 2 (20 minutes into exposure)
|
At time point 2 (20 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Self-reported Positive Affect
Time Frame: At time point 2 (20 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assessed using the shortened Positive and Negative Affect Schedule (PANAS) Positive affect at time point 2 (20 minutes of exposure) Higher scale scores are indicative of better outcome Range 5-50
|
At time point 2 (20 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Self-reported Stress
Time Frame: At time point 2 (20 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assessed using a single-item self report non-validated scale Self-reported stress at time point 2 (20 minutes of exposure) Higher scale score indicative of worse outcome Range 1-5
|
At time point 2 (20 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Self-reported Negative Affect
Time Frame: At time point 2 (20 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assessed using the shortened Positive and Negative Affect Schedule (PANAS) Negative affect at time point 2 (20 minutes of exposure) Higher score on scale indicative of worse outcome Range 5-50
|
At time point 2 (20 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Levels of CRP
Time Frame: At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assessed using blood serum collected via standard clinical methods.
CRP levels at time point 4 (60 minutes of exposure).
|
At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Levels of Cortisol in Serum (ng/mL)
Time Frame: At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assessed using blood serum collected via standard clinical methods Cortisol levels at time point 4 (60 minutes of exposure).
|
At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Blood Pressure (Systolic in mmHg)
Time Frame: At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assessed using mobile physiology equipment Systolic blood pressure at T4 (60 minutes of exposure)
|
At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Level of TNF-alpha
Time Frame: At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assessed using blood serum collected via standard clinical methods TNF-alpha levels at time point 4 (60 minutes of exposure).
|
At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Levels of Il-6
Time Frame: At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
Assessed using blood serum collected via standard clinical methods IL-6 levels at time point 4 (60 minutes of exposure).
|
At time point 4 (60 minutes into duration of exposure for Session 1 and Session 2 (which occurred at least 8 days after Session 1)).
|
|
Baseline Blood Pressure (Diastolic in mmHg)
Time Frame: At baseline (pre-exposure).
|
Assessed using mobile physiology equipment Diastolic blood pressure at baseline.
|
At baseline (pre-exposure).
|
|
Beats Per Minute (BPM)
Time Frame: At baseline (pre-exposure).
|
Assessed using mobile physiology equipment BPM at baseline.
|
At baseline (pre-exposure).
|
|
Skin Conductance (μS)
Time Frame: At baseline (pre-exposure).
|
Assessed using mobile physiology equipment Skin conductance levels at baseline.
|
At baseline (pre-exposure).
|
|
Self-reported Positive Affect
Time Frame: At baseline (pre-exposure).
|
Assessed using the shortened Positive and Negative Affect Schedule (PANAS) Positive affect at baseline Higher scale scores are indicative of better outcome Range 5-50
|
At baseline (pre-exposure).
|
|
Self-reported Stress
Time Frame: At baseline (pre-exposure).
|
Assessed using a single-item self report non-validated scale Self-reported stress at baseline Higher scale score indicative of worse outcome Range 1-5
|
At baseline (pre-exposure).
|
|
Self-reported Negative Affect
Time Frame: At baseline (pre-exposure).
|
Assessed using the shortened Positive and Negative Affect Schedule (PANAS) Negative affect at baseline Higher score on scale indicative of worse outcome Range 5-50
|
At baseline (pre-exposure).
|
|
Levels of CRP
Time Frame: At baseline (pre-exposure).
|
Assessed using blood serum collected via standard clinical methods.
CRP levels at baseline
|
At baseline (pre-exposure).
|
|
Levels of Cortisol in Serum (ng/mL)
Time Frame: At baseline (pre-exposure).
|
Assessed using blood serum collected via standard clinical methods Cortisol levels at baseline
|
At baseline (pre-exposure).
|
|
Blood Pressure (Systolic in mmHg)
Time Frame: At baseline (pre-exposure).
|
Assessed using mobile physiology equipment Systolic blood pressure at baseline
|
At baseline (pre-exposure).
|
|
Level of TNF-alpha
Time Frame: At baseline (pre-exposure).
|
Assessed using blood serum collected via standard clinical methods TNF-alpha levels at baseline
|
At baseline (pre-exposure).
|
|
Levels of Il-6
Time Frame: At baseline (pre-exposure).
|
Assessed using blood serum collected via standard clinical methods IL-6 levels at baseline
|
At baseline (pre-exposure).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of Association of Sum Composite of Absorbed Dose of VOCs in Serum (μg/mL)
Time Frame: Time point 4 (60 min) for absorbed dose associations with same time point for DBP, SBP, Cortisol, Il-6, TNF-alpha, and CRP; and associations with Time point 2 (20 minutes) for HRV, SCL, positive affect, negative affect, self-reported stress, heart rate.
|
Assess the association of absorbed dose (µg/mL) of forest-derived VOCs in serum with primary and secondary outcomes.
|
Time point 4 (60 min) for absorbed dose associations with same time point for DBP, SBP, Cortisol, Il-6, TNF-alpha, and CRP; and associations with Time point 2 (20 minutes) for HRV, SCL, positive affect, negative affect, self-reported stress, heart rate.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gregory Bratman, PhD, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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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