Flotation-REST for Chronic Pain, Stress, and Sleep

University of Missouri (MU)

Status: Withdrawn

Conditions: Musculoskeletal Pain; Healthy; Chronic Pain

Treatments: Behavioral: Dark Room; Behavioral: Flotation-REST

Study type: Interventional

Funder types: Other

Identifiers

NCT04155268

2017263

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Floatation-REST

Experimental group

Description:

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.

Treatment:

Behavioral: Flotation-REST

Dark Room

Active Comparator group

Description:

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.

Treatment:

Behavioral: Dark Room