Clinical trial NCT06072859: The Impact of Simulated Forest Immersion Therapy on Pain and Anxiety in Patients Axial Spondyloarthritis (axSpA)
Official title: The Impact of Simulated Forest Immersion Therapy on Pain and Anxiety in Patients Axial Spondyloarthritis (axSpA)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Axial Spondyloarthritis
Keywords: Forest Oils
Volatile Organic Compounds
Terpenes
Virtual Reality
Pain
Anxiety
Mood
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility quasi-experimental
Primary purpose: SUPPORTIVE_CARE

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.

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* Consent may be withdrawn by the participant at any time during the study.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.

Eligibility criteria: 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

Primary outcomes:
measure: Axial Skeleton Pain
timeFrame: before intervention on visit 1, directly after intervention on visit 1, and one week later
measure: Anxiety
timeFrame: before intervention on visit 1, directly after intervention on visit 1, and one week later
measure: 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
measure: 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
measure: Feasibility Questions
timeFrame: directly after intervention on visit 1
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: before intervention on visit 1, directly after intervention on visit 1, and one week later
measure: Routine Assessment of Patient Index Data 3 (RAPID3)
timeFrame: before intervention on visit 1, directly after intervention on visit 1, and one week later
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Amy Miner Ross, PhD
role: PRINCIPAL_INVESTIGATOR
References: