Flotation-REST for Chronic Pain, Stress, and Sleep
- Conditions
- Chronic PainMusculoskeletal PainHealthy
- Interventions
- Behavioral: Flotation-RESTBehavioral: Dark Room
- Registration Number
- NCT04155268
- Lead Sponsor
- University of Missouri-Columbia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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
- Pregnant
- Started a new sleep or pain medication within the last 6 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Floatation-REST Flotation-REST Participants will float in a shallow pool of water with about 1000 pounds of epsom salt, in a light and sound attenuated device, for up to 60 minutes. Following the session, participants' ratings of the experience will be measured. Dark Room Dark Room Participants will lay on an air mattress in a dark and quiet room, with reduced environmental stimulation, for up to 60 minutes. Following the session, participants' ratings of the experience will be measured.
- Primary Outcome Measures
Name Time Method Sleep 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 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.
Pain intensity 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 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.
- Secondary Outcome Measures
Name Time Method Mystical Experiences Immediately after each intervention Self-reported mystical experiencesassessed with the Mystical Experiences Questionnaire after each intervention where higher scores indicate more mystical-type experiences occurred during the session.
Change in perceived stress Baseline and 1-week after each intervention Perceived Stress Scale; assesses changes in perceived stress where higher scores indicate greater levels of stress
Change in pain interference From baseline to follow-up, approximately 2 weeks Change in daily pain interference where higher scores represent interference in daily activities from pain using the Brief Pain Inventory.
Change in muscle tension or tightness Immediately before and after each intervention Average change in muscle tension from pre- to post-intervention where higher scores indicate greater muscle tension.
Interoception Immediately after each intervention Self-reported interoception assessed with the Multidimensional Interoceptive Awareness Scale after each intervention where higher scores indicate greater interoception during the session.
Insight Immediately after each intervention Self-reported insights assessed with the Psychological Insight Questionnaire after each intervention where higher scores indicate more insight occurred during the session.
Change in Pain Catastrophizing Baseline and 1-week after each intervention Pain Catastrophizing Scale; assesses changes in pain catastrophizing where higher scores indicate greater levels of pain catastrophizing
Emotional Breakthrough Immediately after each intervention Self-reported emotional breakthrough assessed with the Emotional Breakthrough Inventory after each intervention where higher scores indicate more emotional breakthrough occurred during the session.
Change in self-actualization from baseline Baseline, 1- week and 1-month after intervention Self-actualization Scale; 5-point Likert-type scale where the highest score indicates strongest self-actualization
Change in Depression Baseline and 1-week after each intervention Becks Depressive Inventory II; assesses changes in depression where higher scores indicate greater levels of depression
Persisting Effects 1-week after each intervention Persisting Effects Questionnaire: scale of 0 - 5 where 5 is the strongest persisting effect