The Impact of Simulated Forest Immersion Therapy on Pain and Anxiety in Patients Axial Spondyloarthritis (axSpA)

NCT06072859 | Completed

• 1 other identifier: 00025267
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to learn about the ease of using a humidified fragrant citrus forest oil, along with a virtual simulation of a forest environment (i.e., with sights and sounds of nature using a personal tablet Surface Pro 3 with headphones, to learn more about how these two aspects of the simulated forest immersion therapy (SFIT) may improve pain, anxiety, blood-pressure, and heart rate related to Axial Spondyloarthritis. The investigators hope to learn how well SFIT may impact pain levels, feelings of calm, as well as blood- pressure and heart rate, and how participants tolerate the experience overall.

Conditions

Axial Spondyloarthritis

Keywords

Forest Oils; Volatile Organic Compounds; Terpenes; Virtual Reality; Pain; Anxiety; Mood

Outcome Measures

Primary Outcomes (5)

• Axial Skeleton Pain

  Pain on Visual Analog Scale, Scores 0-10 with higher scores reflecting greater pain

  before intervention on visit 1, directly after intervention on visit 1, and one week later

• Anxiety

  Anxiety as scored on STAI - State only Higher scores mean greater state anxiety, 20 items with a scoring range of 1-4 on each of them. Score is totaled and range 20-80 with higher scores reflecting higher anxiety as a state.

  before intervention on visit 1, directly after intervention on visit 1, and one week later

• Blood Pressure

  Blood Pressure measured by Omnicron tabletop BP and HR device, used clinically, higher Blood Pressure, both systolic and diastolic pressures, measured reflect/correlate with higher anxiety or pain status. Measure range 0-240.

  before intervention on visit 1, after 30 minutes of the intervention start on visit 1, directly after intervention on visit 1, and one week later

• Heart Rate

  Heart Rate measured by Omnicron tabletop BP and HR device, used clinically, higher Heart Rate measured reflect/correlate with higher anxiety or pain status. Measure range 0-300.

  before intervention on visit 1, after 30 minutes of the intervention start on visit 1, directly after intervention on visit 1, and one week later

• Feasibility Questions

  Questions regarding the intervention include the tolerance of the intervention, likes and dislikes of the experience and any suggestions to make the intervention experience better.

  directly after intervention on visit 1

Secondary Outcomes (2)

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  before intervention on visit 1, directly after intervention on visit 1, and one week later

• Routine Assessment of Patient Index Data 3 (RAPID3)

  before intervention on visit 1, directly after intervention on visit 1, and one week later

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Humidified Forest Oils with Limonene

Other: Humidified Forest Oils

Group 2

ACTIVE COMPARATOR

Forest oils and audio-visual forest exposure

Other: Forest oils and audio-visual forest exposure

Interventions

Humidified Forest Oils OTHER

60mls Limonene in 200mls water humidified with a diffuser.

Group 1

Forest oils and audio-visual forest exposure OTHER

60mls Limonene in 200mls water humidified with a diffuser and audiovisual Forest sights and sounds on Surface Pro tablet.

Group 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• able to read at a 5th grad level
• medically diagnosed with Axial Spondyloarthritis
• tolerate having their BP and HR taken
• average of greater than 3 on their last recorded pain assessments
• average of greater than 4 on their last BASDI recorded
• currently have an assigned Rheumatologist in their care delivery

You may not qualify if:

• history of asthma
• currently pregnant
• inability to detect common odors from commercial fragrances
• smoking within 15 minutes of the start of the intervention procedure
• known allergy to citrus aroma
• hard of hearing without assistive devices
• limited vision not corrected by eye lenses
• history of hypertension uncontrolled by medications

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Axial Spondyloarthritis; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Amy Miner Ross, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Feasibility quasi-experimental

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 10, 2023
• Study Start: September 21, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)