An interventional study of Flotation-REST and Dark Room in Healthy, Chronic Pain and Musculoskeletal Pain, sponsored by University of Missouri-Columbia. Withdrawn. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-10.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
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.
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.
493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
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Exclusion Criteria:
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
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
Floating in a specialized device (float pod or float cabin) used to attenuate sensory input.
Participants will lay on an air mattress in a dark room with no cell phone and reduced sensory input.
Pain intensity
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
Pain Unpleasantness
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
Stress
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
Sleep
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
Change in pain interference
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
Change in muscle tension or tightness
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
Change in self-actualization from baseline
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
Interoception
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
Insight
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
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.
Time frame: 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.
Time frame: Immediately after each intervention
Change in perceived stress
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
Change in Pain Catastrophizing
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
Change in Depression
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
Persisting Effects
Persisting Effects Questionnaire: scale of 0 - 5 where 5 is the strongest persisting effect
Time frame: 1-week after each intervention
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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University of Missouri-Columbia