Flotation-REST for Chronic Pain, Stress, and Sleep
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Floatation-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. |
Behavioral: Flotation-REST
Floating in a specialized device (float pod or float cabin) used to attenuate sensory input.
|
| Active Comparator: 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. |
Behavioral: Dark Room
Participants will lay on an air mattress in a dark room with no cell phone and reduced sensory input.
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
Secondary Outcome Measures
- 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.
- 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
- 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.
- 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.
- 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 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Psychologically healthy
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Adults between the ages of 18-75 years.
Exclusion Criteria:
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Previous experience in a flotation-REST device.
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Diagnosed with neuropathic pain condition or endorsing more than 4 peripheral neuropathy symptoms.
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Diagnosed with any psychiatric condition (e.g., schizophrenia or bipolar disorder).
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Active suicidality with intent or plan.
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Currently taking SSRI medication.
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History of neurological conditions (e.g., epilepsy, stroke, severe traumatic brain injury, Parkinson's disease, Alzheimer's disease or other forms of dementia)
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Any skin conditions or open wounds that could cause pain when exposed to saltwater
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Inability to lay comfortably for 60 minutes
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Pregnant
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Started a new sleep or pain medication within the last 6 weeks
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Missouri-Columbia
Investigators
- Principal Investigator: Steven Pratscher, University of Missouri-Columbia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017263