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Flotation-REST for Chronic Pain, Stress, and Sleep

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04155268
Enrollment
0
Registered
2019-11-07
Start date
2020-03-09
Completion date
2020-09-08
Last updated
2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Healthy, Musculoskeletal Pain

Keywords

Healthy, Chronic Pain, Floatation-REST, Floating

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.

Interventions

BEHAVIORALFlotation-REST

Floating in a specialized device (float pod or float cabin) used to attenuate sensory input.

BEHAVIORALDark Room

Participants will lay on an air mattress in a dark room with no cell phone and reduced sensory input.

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain intensityFrom baseline to follow-up, approximately 2 weeksChange in daily pain intensity where higher scores represent greater pain reduction using the Brief Pain Inventory
Pain UnpleasantnessFrom baseline to follow-up, approximately 2 weeksChange in daily pain unpleasantness where higher scores represent greater pain unpleasantness using the Brief Pain Inventory.
StressFrom baseline to follow-up, approximately 2 weeksChanges in perceived stress scale and daily diary assessments of stress where higher scores represent higher levels of stress.
SleepFrom baseline to follow-up, approximately 2 weeksSleep Health Index and daily electronic dairies will be used to record sleep parameters. Higher sleep quality represents better sleep.

Secondary

MeasureTime frameDescription
InsightImmediately after each interventionSelf-reported insights assessed with the Psychological Insight Questionnaire after each intervention where higher scores indicate more insight occurred during the session.
Emotional BreakthroughImmediately after each interventionSelf-reported emotional breakthrough assessed with the Emotional Breakthrough Inventory after each intervention where higher scores indicate more emotional breakthrough occurred during the session.
Mystical ExperiencesImmediately after each interventionSelf-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 pain interferenceFrom baseline to follow-up, approximately 2 weeksChange in daily pain interference where higher scores represent interference in daily activities from pain using the Brief Pain Inventory.
Change in Pain CatastrophizingBaseline and 1-week after each interventionPain Catastrophizing Scale; assesses changes in pain catastrophizing where higher scores indicate greater levels of pain catastrophizing
Change in DepressionBaseline and 1-week after each interventionBecks Depressive Inventory II; assesses changes in depression where higher scores indicate greater levels of depression
Persisting Effects1-week after each interventionPersisting Effects Questionnaire: scale of 0 - 5 where 5 is the strongest persisting effect
Change in perceived stressBaseline and 1-week after each interventionPerceived Stress Scale; assesses changes in perceived stress where higher scores indicate greater levels of stress
Change in muscle tension or tightnessImmediately before and after each interventionAverage change in muscle tension from pre- to post-intervention where higher scores indicate greater muscle tension.
Change in self-actualization from baselineBaseline, 1- week and 1-month after interventionSelf-actualization Scale; 5-point Likert-type scale where the highest score indicates strongest self-actualization
InteroceptionImmediately after each interventionSelf-reported interoception assessed with the Multidimensional Interoceptive Awareness Scale after each intervention where higher scores indicate greater interoception during the session.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026