The Impact of Simulated Forest Immersion Therapy on Pain and Anxiety in Patients Axial Spondyloar… (NCT06072859) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Simulated Forest Immersion Therapy on Pain and Anxiety in Patients Axial Spondyloarthritis (axSpA)
United States10 participantsStarted 2023-09-21
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Axial Skeleton Pain
Timeframe: before intervention on visit 1, directly after intervention on visit 1, and one week later
2
Anxiety
Timeframe: before intervention on visit 1, directly after intervention on visit 1, and one week later
3
Blood Pressure
Timeframe: 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
4
Heart Rate
Timeframe: 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