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

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy; Musculoskeletal Pain; Chronic Pain
• Intervention / Treatment: Behavioral: Flotation-REST; Behavioral: Dark Room

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Steven Pratscher, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Anticipated): March 9, 2020
• Primary Completion (Actual): September 8, 2020
• Study Completion (Actual): September 8, 2020

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Chronic Pain; Healthy; Floatation-REST; Floating
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Chronic Pain; Musculoskeletal Pain
• Other Study ID Numbers: 2017263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No