Flotation-REST for Chronic Pain, Stress, and Sleep

NCT ID: NCT04155268

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2020-09-08

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.

Conditions

Healthy; Chronic Pain; Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Flotation-REST

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Dark Room

Intervention Type: BEHAVIORAL

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

Interventions

Flotation-REST

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

Intervention Type: BEHAVIORAL

Dark Room

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Steven Pratscher

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Pratscher

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Other Identifiers

2017263

Identifier Type: -

Identifier Source: org_study_id