Axial SpondyloarthritisNCT06072859
The Impact of Simulated Forest Immersion Therapy on Pain and Anxiety in Patients Axial Spondyloarthritis (axSpA)
A study testing Humidified Forest Oils and Forest oils and audio-visual forest exposure in people with Axial Spondyloarthritis, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Humidified Forest Oils and Forest oils and audio-visual forest exposure
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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.
Read the detailed description
DURATION:
Participation in the study will consist of 1 visit total and will last up to 2 consecutive hours.
PROCEDURES:
Participants will be randomized to receive either the forest oils only, or the forest oils and audio-visual forest exposure described above for up to 1 hour.
Study Visit:
- During Visit 1 and the only study visit, the investigator will explain the study and obtain consent. The Investigator will explain this study and answer any questions the participant may have. The participant will have the opportunity to review this document in detail.
- Consent may be withdrawn by the participant at any time during the study.
- Once the written consent is signed, the participant will be asked to rest for 15 minutes.
- During the resting period, randomization will occur into one of two groups:
- Group 1 - Forest oils only, or
- Group 2 - Forest oils and audio-visual forest exposure
- Following the resting period, demographics will be collected from the participants.
- The investigators will then take a blood pressure and heart rate measurement.
- Then, the investigator will ask the participants to fill out two questionnaires. One of these questionnaires consists of two questions asking the participants about their pain level and location, the other questionnaire asks about mood state and how the participants rate various qualities of their feelings. The third questionnaire asks the participants about their pain levels specific to the past week.
- Participants will then be taken into the study room where they will participate in the simulated forest experience.
- If the participants are randomly assigned to Group 1, they will be breathing in the aroma of the forest oils for a period of 1 hour in the study room. There is an adjustable lounge chair in the room to sit in. And the participants may read or use their phone quietly.
- If the participants are randomly assigned to Group 2, they will be breathing in the aroma of the forest oils for a period of 1 hour in the study room while using the headphones and tablet with the simulated forest greenspace sights and sounds. There is an adjustable lounge chair in the room to sit in.
- The investigator will take the participants blood pressure and heart rate measurement after 30 minutes from the start of the intervention.
- Within 15 minutes following the simulated experience in the study room, the investigator will take one more blood-pressure and heart rate measurement. Then, the participants will fill out the same two questionnaires again, which are asking the participants about their pain level and location and mood.
- The investigators will then ask the participants some questions about the participants' experience before the end of the study visit.
- One week after the participants study visit (Study Visit 1), the investigator will ask the participants to return two follow-up questionnaires to us over encrypted and password protected OHSU email, or by arranging to drop the questionnaires off with the Study Coordinator or the Rheumatology Clinic at OHSU.
RISKS: There are three risks to participation in this study and these are all considered minimal risks. Participants may have an allergic reaction, a cough, or an increase in asthma type symptoms, such as difficulty breathing related to the humidified fragrant citrus forest oil used in this study. For those in Group 2, the participants may experience a sensation of nausea (feeling queasy), discomfort related to the headphone placement, sound disturbances related to the volume of the nature sounds, or discomfort related to viewing the images of the forest greenspace environment utilized in this study. the investigators will make every effort to protect the participants privacy during this study, including password protected files, secure and encrypted email, and double locked file system. A loss of confidentiality happens when the participants private information is accessed outside the scope of this study. A loss of confidentiality is an unexpected event.
BENEFITS: Participants may not directly benefit from taking part in this research. However, participation will potentially benefit patients with Axial Spondyloarthritis in the future.
- Conditions
- Axial Spondyloarthritis
- Being tested
- Humidified Forest Oils, Forest oils and audio-visual forest exposure
- Keywords
- Forest Oils, Volatile Organic Compounds, Terpenes, Virtual Reality, Pain, Anxiety, Mood
- Medical subject headings
- Axial Spondyloarthritis, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humidified Forest OilsOther
60mls Limonene in 200mls water humidified with a diffuser.
Forest oils and audio-visual forest exposureOther
60mls Limonene in 200mls water humidified with a diffuser and audiovisual Forest sights and sounds on Surface Pro tablet.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Humidified Forest Oils with Limonene Receives: Other: Humidified Forest Oils |
| Group 2 | Active comparator | Forest oils and audio-visual forest exposure Receives: Other: Forest oils and audio-visual forest exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial Skeleton Pain
Pain on Visual Analog Scale, Scores 0-10 with higher scores reflecting greater pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: directly after intervention on visit 1
Secondary outcomes (2)
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Measures pain and functionality in Axial Spondyloarthritis by assessing individual metrics for fatigue, axial involvement, peripheral articular involvement, localized tenderness/enthesitis, and morning stiffness. Score 0-10 with higher scores reflecting higher pain and functionality issues.
Measured: before intervention on visit 1, directly after intervention on visit 1, and one week later
Routine Assessment of Patient Index Data 3 (RAPID3)
composite index which is routinely and reliably used to assess disease activity in Axial Spondyloarthritis. Score range 0-30 with higher scores reflecting higher disease activity.
Measured: before intervention on visit 1, directly after intervention on visit 1, and one week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start21 Sep 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Feasibility quasi-experimental
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Ross, Oregon Health and Science University
- Investigators
- Amy Miner Ross, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072859
- Sponsor's protocol ID
- 00025267
- Status last verified
- Jul 2025
- First submitted
- 26 Sep 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Simulated Forest Immersion Therapy on Pain and Anxiety in Patients Axial Spondyloarthritis (axSpA)
- ClinicalTrials.gov ID
- NCT06072859
- Acronym / sponsor ID
- 00025267
- Conditions
- Axial Spondyloarthritis
- Keywords
- Forest Oils, Volatile Organic Compounds, Terpenes, Virtual Reality, Pain, Anxiety, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
DURATION:
Participation in the study will consist of 1 visit total and will last up to 2 consecutive hours.
PROCEDURES:
Participants will be randomized to receive either the forest oils only, or the forest oils and audio-visual forest exposure described above for up to 1 hour.
Study Visit:
- During Visit 1 and the only study visit, the investigator will explain the study and obtain consent. The Investigator will explain this study and answer any questions the participant may have. The participant will have the opportunity to review this document in detail.
- Consent may be withdrawn by the participant at any time during the study.
- Once the written consent is signed, the participant will be asked to rest for 15 minutes.
- During the resting period, randomization will occur into one of two groups:
- Group 1 - Forest oils only, or
- Group 2 - Forest oils and audio-visual forest exposure
- Following the resting period, demographics will be collected from the participants.
- The investigators will then take a blood pressure and heart rate measurement.
- Then, the investigator will ask the participants to fill out two questionnaires. One of these questionnaires consists of two questions asking the participants about their pain level and location, the other questionnaire asks about mood state and how the participants rate various qualities of their feelings. The third questionnaire asks the participants about their pain levels specific to the past week.
- Participants will then be taken into the study room where they will participate in the simulated forest experience.
- If the participants are randomly assigned to Group 1, they will be breathing in the aroma of the forest oils for a period of 1 hour in the study room. There is an adjustable lounge chair in the room to sit in. And the participants may read or use their phone quietly.
- If the participants are randomly assigned to Group 2, they will be breathing in the aroma of the forest oils for a period of 1 hour in the study room while using the headphones and tablet with the simulated forest greenspace sights and sounds. There is an adjustable lounge chair in the room to sit in.
- The investigator will take the participants blood pressure and heart rate measurement after 30 minutes from the start of the intervention.
- Within 15 minutes following the simulated experience in the study room, the investigator will take one more blood-pressure and heart rate measurement. Then, the participants will fill out the same two questionnaires again, which are asking the participants about their pain level and location and mood.
- The investigators will then ask the participants some questions about the participants' experience before the end of the study visit.
- One week after the participants study visit (Study Visit 1), the investigator will ask the participants to return two follow-up questionnaires to us over encrypted and password protected OHSU email, or by arranging to drop the questionnaires off with the Study Coordinator or the Rheumatology Clinic at OHSU.
RISKS: There are three risks to participation in this study and these are all considered minimal risks. Participants may have an allergic reaction, a cough, or an increase in asthma type symptoms, such as difficulty breathing related to the humidified fragrant citrus forest oil used in this study. For those in Group 2, the participants may experience a sensation of nausea (feeling queasy), discomfort related to the headphone placement, sound disturbances related to the volume of the nature sounds, or discomfort related to viewing the images of the forest greenspace environment utilized in this study. the investigators will make every effort to protect the participants privacy during this study, including password protected files, secure and encrypted email, and double locked file system. A loss of confidentiality happens when the participants private information is accessed outside the scope of this study. A loss of confidentiality is an unexpected event.
BENEFITS: Participants may not directly benefit from taking part in this research. However, participation will potentially benefit patients with Axial Spondyloarthritis in the future.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasibility quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Other: Humidified Forest OilsHumidified Forest Oils with Limonene |
| Group 2 | Active comparator | Other: Forest oils and audio-visual forest exposureForest oils and audio-visual forest exposure |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humidified Forest Oils60mls Limonene in 200mls water humidified with a diffuser. | Other | Group 1 |
| Forest oils and audio-visual forest exposure60mls Limonene in 200mls water humidified with a diffuser and audiovisual Forest sights and sounds on Surface Pro tablet. | Other | Group 2 |
Primary outcome
Axial Skeleton Pain
Time frame: before intervention on visit 1, directly after intervention on visit 1, and one week later
Pain on Visual Analog Scale, Scores 0-10 with higher scores reflecting greater pain
Anxiety
Time frame: before intervention on visit 1, directly after intervention on visit 1, and one week later
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.
Blood Pressure
Time frame: 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
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.
Heart Rate
Time frame: 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 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.
Feasibility Questions
Time frame: directly after intervention on visit 1
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.
2 secondary outcomes
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: before intervention on visit 1, directly after intervention on visit 1, and one week later
Routine Assessment of Patient Index Data 3 (RAPID3)
Time frame: before intervention on visit 1, directly after intervention on visit 1, and one week later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Miner Ross, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humidified Forest Oils and Forest oils and audio-visual forest exposure in people with Axial Spondyloarthritis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial Skeleton Pain (time frame: before intervention on visit 1, directly after intervention on visit 1, and one week later). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.