Flotation-REST for Chronic Pain, Stress, and Sleep

September 8, 2020 updated by: Steven Pratscher, University of Missouri-Columbia

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: From baseline to follow-up, approximately 2 weeks
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
Time Frame: From baseline to follow-up, approximately 2 weeks
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
Time Frame: From baseline to follow-up, approximately 2 weeks
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
Time Frame: From baseline to follow-up, approximately 2 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pain interference
Time Frame: From baseline to follow-up, approximately 2 weeks
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
Time Frame: Immediately before and after each intervention
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
Time Frame: Baseline, 1- week and 1-month after intervention
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
Time Frame: Immediately after each intervention
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
Time Frame: Immediately after each intervention
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
Time Frame: Immediately after each intervention
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
Time Frame: Immediately after each intervention
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
Time Frame: Baseline and 1-week after each intervention
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
Time Frame: Baseline and 1-week after each intervention
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
Time Frame: Baseline and 1-week after each intervention
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
Time Frame: 1-week after each intervention
Persisting Effects Questionnaire: scale of 0 - 5 where 5 is the strongest persisting effect
1-week after each intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Missouri-Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven Pratscher, University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 8, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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