NCT05316597

Brief Summary

This pilot study evaluates the role terpenes play in the stress-reducing effects of a forest bathing intervention. Participants will participate in two interventions in random order: 1) terpene exposure and 2) no terpene exposure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

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

First Submitted

Initial submission to the registry

March 9, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 12, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
12 months until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

1.2 years

First QC Date

March 9, 2022

Results QC Date

June 15, 2024

Last Update Submit

August 21, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Changes in the HF (ms^2) Component of HRV

    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

    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 Outcomes (22)

  • Blood Pressure (Diastolic in mmHg)

    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)

    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)

    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

    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

    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)).

  • +17 more secondary outcomes

Other Outcomes (1)

  • Degree of Association of Sum Composite of Absorbed Dose of VOCs in Serum (μg/mL)

    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.

Study Arms (2)

Terpenes On

EXPERIMENTAL

Forest bathing intervention with no filtration of terpenes from inhaled air using PAPR with particle-only filter ("terpenes on")

Behavioral: Forest bathing

Terpenes Off

ACTIVE COMPARATOR

Forest bathing intervention with filtration of terpenes from inhaled air using PAPR with activated charcoal filter ("terpenes off")

Behavioral: Forest bathing

Interventions

Forest bathingBEHAVIORAL

Participants will be seated in a forest environment for an hour-long exposure to the forest

Terpenes OffTerpenes On

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Non-smoker
  • Physically capable of walking for approximately 15-20 min from the study vehicle to the clinic and experimental locations.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pack Forest

Eatonville, Washington, 98328, United States

Location

MeSH Terms

Interventions

Forest Therapy

Intervention Hierarchy (Ancestors)

Relaxation TherapyMind-Body TherapiesComplementary TherapiesTherapeutics

Results Point of Contact

Title
Dr. Gregory Bratman
Organization
University of Washington

Study Officials

  • Gregory Bratman, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants and research staff conducting the intervention will be masked to the exposure
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Participants are assigned to both arms in random order
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor: Environmental and Forest Sciences

Study Record Dates

First Submitted

March 9, 2022

First Posted

April 7, 2022

Study Start

July 12, 2022

Primary Completion

September 21, 2023

Study Completion

September 21, 2023

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-08

Locations