Daily Assessments of Pain, Stress, and Sleep Following Flotation-REST: A Randomized Crossover Trial for Those With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Pain intensity
研究概览
简要总结
This randomized crossover trial aims to examine the effects of Flotation-REST (Reduced, Environmental, Stimulation, Technique/Therapy) compared to laying in a dark room (with reduced environmental stimulation) for those with chronic musculoskeletal pain. This design will allow for comparisons between the two interventions on daily diary assessments of pain, stress, and sleep, both between groups and within individuals.
详细描述
Chronic pain is a prevalent and significant health problem. Previous research shows that Flotation-REST may be an effective treatment for reducing pain but little is known about the short-term effects of a single session of Flotation-REST on the day-to-day variability of pain, stress, and sleep. Sleep, stress, and pain are all bidirectionally related to each other, and previous research shows that Flotation-REST may positively influence all three of these outcomes. Therefore, the primary aim of this study is to examine changes in pain, stress, and sleep following Flotation-REST. The secondary aim is to investigate whether various subjective experiences during the intervention are associated with changes in pain, stress, and sleep following the interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chronic musculoskeletal pain (e.g., back pain or upper or lower extremity pain, arthritis, fibromyalgia) on more days than not for the past 3 months
- •Psychologically healthy
- •Adults between the ages of 18-75 years.
排除标准
- •Previous experience in a flotation-REST device.
- •Diagnosed with neuropathic pain condition or endorsing more than 4 peripheral neuropathy symptoms.
- •Diagnosed with any psychiatric condition (e.g., schizophrenia or bipolar disorder).
- •Active suicidality with intent or plan.
- •Currently taking SSRI medication.
- •History of neurological conditions (e.g., epilepsy, stroke, severe traumatic brain injury, Parkinson's disease, Alzheimer's disease or other forms of dementia)
- •Any skin conditions or open wounds that could cause pain when exposed to saltwater
- •Inability to lay comfortably for 60 minutes
- •Started a new sleep or pain medication within the last 6 weeks
结局指标
主要结局
Pain intensity
时间窗: From baseline to follow-up, approximately 2 weeks
Change in daily pain intensity where higher scores represent greater pain reduction using the Brief Pain Inventory
Pain Unpleasantness
时间窗: From baseline to follow-up, approximately 2 weeks
Change in daily pain unpleasantness where higher scores represent greater pain unpleasantness using the Brief Pain Inventory.
Sleep
时间窗: From baseline to follow-up, approximately 2 weeks
Sleep Health Index and daily electronic dairies will be used to record sleep parameters. Higher sleep quality represents better sleep.
Stress
时间窗: From baseline to follow-up, approximately 2 weeks
Changes in perceived stress scale and daily diary assessments of stress where higher scores represent higher levels of stress.
次要结局
- Change in pain interference(From baseline to follow-up, approximately 2 weeks)
- Change in muscle tension or tightness(Immediately before and after each intervention)
- Interoception(Immediately after each intervention)
- Insight(Immediately after each intervention)
- Change in Pain Catastrophizing(Baseline and 1-week after each intervention)
- Mystical Experiences(Immediately after each intervention)
- Change in perceived stress(Baseline and 1-week after each intervention)
- Emotional Breakthrough(Immediately after each intervention)
- Change in self-actualization from baseline(Baseline, 1- week and 1-month after intervention)
- Change in Depression(Baseline and 1-week after each intervention)
- Persisting Effects(1-week after each intervention)
研究者
Steven Pratscher
Principal Investigator
University of Missouri-Columbia