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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06072859
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Oregon Health and Science University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Amy Miner Ross, PhD
Principal Investigator Affiliation Oregon Health and Science University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Axial Spondyloarthritis
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Group 1

Humidified Forest Oils with Limonene

Active Comparator: Group 2

Humidified Forest Oils with Limonene & Virtual Reality using a Surface Pro tablet with headphones to experience walking on a forest path and ambient forest sounds.

Interventions

Other: - Humidified Forest Oils

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

Other: - Virtual Reality using Surface Pro and headphones

Surface Pro has a looped visual that can be manipulated by the participant to simulate walking on a forest path or through a forest visual. This is paired with headphones to experience ambient forest sounds.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Oregon Health & Science University, Portland, Oregon

Status

Address

Oregon Health & Science University

Portland, Oregon, 97239