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Flotation-REST for Chronic Pain, Stress, and Sleep

Primary Purpose

Healthy, Chronic Pain, Musculoskeletal Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Flotation-REST
Dark Room
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Healthy, Chronic Pain, Floatation-REST, Floating

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Floatation-REST

    Dark Room

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Pain intensity
    Change in daily pain intensity where higher scores represent greater pain reduction using the Brief Pain Inventory
    Pain Unpleasantness
    Change in daily pain unpleasantness where higher scores represent greater pain unpleasantness using the Brief Pain Inventory.
    Stress
    Changes in perceived stress scale and daily diary assessments of stress where higher scores represent higher levels of stress.
    Sleep
    Sleep Health Index and daily electronic dairies will be used to record sleep parameters. Higher sleep quality represents better sleep.

    Secondary Outcome Measures

    Change in pain interference
    Change in daily pain interference where higher scores represent interference in daily activities from pain using the Brief Pain Inventory.
    Change in muscle tension or tightness
    Average change in muscle tension from pre- to post-intervention where higher scores indicate greater muscle tension.
    Change in self-actualization from baseline
    Self-actualization Scale; 5-point Likert-type scale where the highest score indicates strongest self-actualization
    Interoception
    Self-reported interoception assessed with the Multidimensional Interoceptive Awareness Scale after each intervention where higher scores indicate greater interoception during the session.
    Insight
    Self-reported insights assessed with the Psychological Insight Questionnaire after each intervention where higher scores indicate more insight occurred during the session.
    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.
    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.
    Change in perceived stress
    Perceived Stress Scale; assesses changes in perceived stress where higher scores indicate greater levels of stress
    Change in Pain Catastrophizing
    Pain Catastrophizing Scale; assesses changes in pain catastrophizing where higher scores indicate greater levels of pain catastrophizing
    Change in Depression
    Becks Depressive Inventory II; assesses changes in depression where higher scores indicate greater levels of depression
    Persisting Effects
    Persisting Effects Questionnaire: scale of 0 - 5 where 5 is the strongest persisting effect

    Full Information

    First Posted
    October 18, 2019
    Last Updated
    September 8, 2020
    Sponsor
    University of Missouri-Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04155268
    Brief Title
    Flotation-REST for Chronic Pain, Stress, and Sleep
    Official Title
    Daily Assessments of Pain, Stress, and Sleep Following Flotation-REST: A Randomized Crossover Trial for Those With Chronic Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Unable to conduct the study due to Covid-19.
    Study Start Date
    March 9, 2020 (Anticipated)
    Primary Completion Date
    September 8, 2020 (Actual)
    Study Completion Date
    September 8, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Missouri-Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy, Chronic Pain, Musculoskeletal Pain
    Keywords
    Healthy, Chronic Pain, Floatation-REST, Floating

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Floatation-REST
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Dark Room
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Flotation-REST
    Intervention Description
    Floating in a specialized device (float pod or float cabin) used to attenuate sensory input.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dark Room
    Intervention Description
    Participants will lay on an air mattress in a dark room with no cell phone and reduced sensory input.
    Primary Outcome Measure Information:
    Title
    Pain intensity
    Description
    Change in daily pain intensity where higher scores represent greater pain reduction using the Brief Pain Inventory
    Time Frame
    From baseline to follow-up, approximately 2 weeks
    Title
    Pain Unpleasantness
    Description
    Change in daily pain unpleasantness where higher scores represent greater pain unpleasantness using the Brief Pain Inventory.
    Time Frame
    From baseline to follow-up, approximately 2 weeks
    Title
    Stress
    Description
    Changes in perceived stress scale and daily diary assessments of stress where higher scores represent higher levels of stress.
    Time Frame
    From baseline to follow-up, approximately 2 weeks
    Title
    Sleep
    Description
    Sleep Health Index and daily electronic dairies will be used to record sleep parameters. Higher sleep quality represents better sleep.
    Time Frame
    From baseline to follow-up, approximately 2 weeks
    Secondary Outcome Measure Information:
    Title
    Change in pain interference
    Description
    Change in daily pain interference where higher scores represent interference in daily activities from pain using the Brief Pain Inventory.
    Time Frame
    From baseline to follow-up, approximately 2 weeks
    Title
    Change in muscle tension or tightness
    Description
    Average change in muscle tension from pre- to post-intervention where higher scores indicate greater muscle tension.
    Time Frame
    Immediately before and after each intervention
    Title
    Change in self-actualization from baseline
    Description
    Self-actualization Scale; 5-point Likert-type scale where the highest score indicates strongest self-actualization
    Time Frame
    Baseline, 1- week and 1-month after intervention
    Title
    Interoception
    Description
    Self-reported interoception assessed with the Multidimensional Interoceptive Awareness Scale after each intervention where higher scores indicate greater interoception during the session.
    Time Frame
    Immediately after each intervention
    Title
    Insight
    Description
    Self-reported insights assessed with the Psychological Insight Questionnaire after each intervention where higher scores indicate more insight occurred during the session.
    Time Frame
    Immediately after each intervention
    Title
    Emotional Breakthrough
    Description
    Self-reported emotional breakthrough assessed with the Emotional Breakthrough Inventory after each intervention where higher scores indicate more emotional breakthrough occurred during the session.
    Time Frame
    Immediately after each intervention
    Title
    Mystical Experiences
    Description
    Self-reported mystical experiencesassessed with the Mystical Experiences Questionnaire after each intervention where higher scores indicate more mystical-type experiences occurred during the session.
    Time Frame
    Immediately after each intervention
    Title
    Change in perceived stress
    Description
    Perceived Stress Scale; assesses changes in perceived stress where higher scores indicate greater levels of stress
    Time Frame
    Baseline and 1-week after each intervention
    Title
    Change in Pain Catastrophizing
    Description
    Pain Catastrophizing Scale; assesses changes in pain catastrophizing where higher scores indicate greater levels of pain catastrophizing
    Time Frame
    Baseline and 1-week after each intervention
    Title
    Change in Depression
    Description
    Becks Depressive Inventory II; assesses changes in depression where higher scores indicate greater levels of depression
    Time Frame
    Baseline and 1-week after each intervention
    Title
    Persisting Effects
    Description
    Persisting Effects Questionnaire: scale of 0 - 5 where 5 is the strongest persisting effect
    Time Frame
    1-week after each intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Steven Pratscher
    Organizational Affiliation
    University of Missouri-Columbia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Flotation-REST for Chronic Pain, Stress, and Sleep

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