Flotation-REST for Chronic Pain, Stress, and Sleep

Study Overview
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Brief Summary
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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
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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.

Official Title
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Daily Assessments of Pain, Stress, and Sleep Following Flotation-REST: A Randomized Crossover Trial for Those With Chronic Pain

Conditions
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Healthy, Chronic Pain, Musculoskeletal Pain

Intervention / Treatment
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* Behavioral: Flotation-REST
* Behavioral: Dark Room


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Floatation-REST<br>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<br>* Floating in a specialized device (float pod or float cabin) used to attenuate sensory input.<br>|
| Active Comparator: Dark Room<br>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<br>* Participants will lay on an air mattress in a dark room with no cell phone and reduced sensory input.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Change in daily pain intensity where higher scores represent greater pain reduction using the Brief Pain Inventory | From baseline to follow-up, approximately 2 weeks | 
| Pain Unpleasantness | Change in daily pain unpleasantness where higher scores represent greater pain unpleasantness using the Brief Pain Inventory. | From baseline to follow-up, approximately 2 weeks | 
| Stress | Changes in perceived stress scale and daily diary assessments of stress where higher scores represent higher levels of stress. | From baseline to follow-up, approximately 2 weeks | 
| Sleep | Sleep Health Index and daily electronic dairies will be used to record sleep parameters. Higher sleep quality represents better sleep. | From baseline to follow-up, approximately 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain interference | Change in daily pain interference where higher scores represent interference in daily activities from pain using the Brief Pain Inventory. | From baseline to follow-up, approximately 2 weeks | 
| Change in muscle tension or tightness | Average change in muscle tension from pre- to post-intervention where higher scores indicate greater muscle tension. | Immediately before and after each intervention | 
| Change in self-actualization from baseline | Self-actualization Scale; 5-point Likert-type scale where the highest score indicates strongest self-actualization | Baseline, 1- week and 1-month after intervention | 
| Interoception | Self-reported interoception assessed with the Multidimensional Interoceptive Awareness Scale after each intervention where higher scores indicate greater interoception during the session. | Immediately after each intervention | 
| Insight | Self-reported insights assessed with the Psychological Insight Questionnaire after each intervention where higher scores indicate more insight occurred during the session. | Immediately after each intervention | 
| Emotional Breakthrough | Self-reported emotional breakthrough assessed with the Emotional Breakthrough Inventory after each intervention where higher scores indicate more emotional breakthrough occurred during the session. | Immediately after each intervention | 
| Mystical Experiences | Self-reported mystical experiencesassessed with the Mystical Experiences Questionnaire after each intervention where higher scores indicate more mystical-type experiences occurred during the session. | Immediately after each intervention | 
| Change in perceived stress | Perceived Stress Scale; assesses changes in perceived stress where higher scores indicate greater levels of stress | Baseline and 1-week after each intervention | 
| Change in Pain Catastrophizing | Pain Catastrophizing Scale; assesses changes in pain catastrophizing where higher scores indicate greater levels of pain catastrophizing | Baseline and 1-week after each intervention | 
| Change in Depression | Becks Depressive Inventory II; assesses changes in depression where higher scores indicate greater levels of depression | Baseline and 1-week after each intervention | 
| Persisting Effects | Persisting Effects Questionnaire: scale of 0 - 5 where 5 is the strongest persisting effect | 1-week after each intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Chronic Pain, Floatation-REST, Floating