Clinical trial NCT04155268: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Chronic Pain
Musculoskeletal Pain
Keywords: Healthy
Chronic Pain
Floatation-REST
Floating
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain intensity
timeFrame: From baseline to follow-up, approximately 2 weeks
measure: Pain Unpleasantness
timeFrame: From baseline to follow-up, approximately 2 weeks
measure: Stress
timeFrame: From baseline to follow-up, approximately 2 weeks
measure: Sleep
timeFrame: From baseline to follow-up, approximately 2 weeks
Secondary outcomes:
measure: Change in pain interference
timeFrame: From baseline to follow-up, approximately 2 weeks
measure: Change in muscle tension or tightness
timeFrame: Immediately before and after each intervention
measure: Change in self-actualization from baseline
timeFrame: Baseline, 1- week and 1-month after intervention
measure: Interoception
timeFrame: Immediately after each intervention
measure: Insight
timeFrame: Immediately after each intervention
measure: Emotional Breakthrough
timeFrame: Immediately after each intervention
measure: Mystical Experiences
timeFrame: Immediately after each intervention
measure: Change in perceived stress
timeFrame: Baseline and 1-week after each intervention
measure: Change in Pain Catastrophizing
timeFrame: Baseline and 1-week after each intervention
measure: Change in Depression
timeFrame: Baseline and 1-week after each intervention
measure: Persisting Effects
timeFrame: 1-week after each intervention
Other outcomes:
Locations:
Study officials:
affiliation: University of Missouri-Columbia
name: Steven Pratscher
role: PRINCIPAL_INVESTIGATOR
References: