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Flotation-REST for Chronic Pain, Stress, and Sleep

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ClinicalTrials.gov Identifier: NCT04155268
Recruitment Status : Withdrawn (Unable to conduct the study due to Covid-19.)
First Posted : November 7, 2019
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Steven Pratscher, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Healthy Chronic Pain Musculoskeletal Pain Behavioral: Flotation-REST Behavioral: Dark Room Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Daily Assessments of Pain, Stress, and Sleep Following Flotation-REST: A Randomized Crossover Trial for Those With Chronic Pain
Estimated Study Start Date : March 9, 2020
Actual Primary Completion Date : September 8, 2020
Actual Study Completion Date : September 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

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.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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

  11. Persisting Effects [ Time Frame: 1-week after each intervention ]
    Persisting Effects Questionnaire: scale of 0 - 5 where 5 is the strongest persisting effect



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155268


Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Steven Pratscher University of Missouri-Columbia
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Responsible Party: Steven Pratscher, Principal Investigator, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT04155268    
Other Study ID Numbers: 2017263
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Steven Pratscher, University of Missouri-Columbia:
Healthy
Chronic Pain
Floatation-REST
Floating
Additional relevant MeSH terms:
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Musculoskeletal Pain
Chronic Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases