Oregon Health & Science University
Portland, Oregon, 97239, United States
NCT Number: NCT06072859
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.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Portland, Oregon, 97239, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
60mls Limonene in 200mls water humidified with a diffuser.
60mls Limonene in 200mls water humidified with a diffuser and audiovisual Forest sights and sounds on Surface Pro tablet.
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
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.
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.
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.
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.
Time frame: before intervention on visit 1, directly after intervention on visit 1, and one week later
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.
Time frame: before intervention on visit 1, directly after intervention on visit 1, and one week later
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.
Oregon Health and Science University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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