The Impact of Simulated Forest Immersion Therapy on Pain and Anxiety in Patients Axial Spondyloarthritis (axSpA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Axial Skeleton Pain
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Axial Skeleton Pain
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(before intervention on visit 1, directly after intervention on visit 1, and one week later)
- Routine Assessment of Patient Index Data 3 (RAPID3)(before intervention on visit 1, directly after intervention on visit 1, and one week later)
研究者
Amy Ross
Associate Professor
Oregon Health and Science University