HealthyNCT04155268
Flotation-REST for Chronic Pain, Stress, and Sleep
A study testing Flotation-REST and Dark Room in people with Healthy and Chronic Pain, run by University of Missouri-Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Chronic Pain, Musculoskeletal Pain
- What is being tested?
- Flotation-REST and Dark Room
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2020to 8 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy, Chronic Pain, Musculoskeletal Pain
- Being tested
- Flotation-REST, Dark Room
- Keywords
- Healthy, Chronic Pain, Floatation-REST, Floating
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flotation-RESTBehavioural
Floating in a specialized device (float pod or float cabin) used to attenuate sensory input.
Dark RoomBehavioural
Participants will lay on an air mattress in a dark room with no cell phone and reduced sensory input.
| Study group | Role | What they receive |
|---|---|---|
| Floatation-REST | Experimental | 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. Receives: Behavioral: Flotation-REST |
| Dark Room | Active comparator | 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. Receives: Behavioral: Dark Room |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Change in daily pain intensity where higher scores represent greater pain reduction using the Brief Pain Inventory
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to follow-up, approximately 2 weeks
Secondary outcomes (11)
Change in pain interference
Change in daily pain interference where higher scores represent interference in daily activities from pain using the Brief Pain Inventory.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after each intervention
Change in perceived stress
Perceived Stress Scale; assesses changes in perceived stress where higher scores indicate greater levels of stress
Measured: 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
Measured: 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
Measured: Baseline and 1-week after each intervention
Persisting Effects
Persisting Effects Questionnaire: scale of 0 - 5 where 5 is the strongest persisting effect
Measured: 1-week after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start9 Mar 2020 (estimated)
- Primary completion8 Sep 2020
- Study completion8 Sep 2020
Why it stopped: Unable to conduct the study due to Covid-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Pratscher, University of Missouri-Columbia
- Investigators
- Steven Pratscher, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155268
- Sponsor's protocol ID
- 2017263
- Status last verified
- Sep 2020
- First submitted
- 18 Oct 2019
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Assessments of Pain, Stress, and Sleep Following Flotation-REST: A Randomized Crossover Trial for Those With Chronic Pain
- ClinicalTrials.gov ID
- NCT04155268
- Acronym / sponsor ID
- 2017263
- Conditions
- Healthy, Chronic Pain, Musculoskeletal Pain
- Keywords
- Healthy, Chronic Pain, Floatation-REST, Floating
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to conduct the study due to Covid-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 9 Mar 2020 (estimated)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 8 Sep 2020 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Floatation-REST | Experimental | Behavioral: Flotation-RESTParticipants 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. |
| Dark Room | Active comparator | Behavioral: Dark RoomParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flotation-RESTFloating in a specialized device (float pod or float cabin) used to attenuate sensory input. | Behavioural | Floatation-REST |
| Dark RoomParticipants will lay on an air mattress in a dark room with no cell phone and reduced sensory input. | Behavioural | Dark Room |
Primary outcome
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
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.
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.
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.
11 secondary outcomes
Change in pain interference
Time frame: From baseline to follow-up, approximately 2 weeks
Change in muscle tension or tightness
Time frame: Immediately before and after each intervention
Change in self-actualization from baseline
Time frame: Baseline, 1- week and 1-month after intervention
Interoception
Time frame: Immediately after each intervention
Insight
Time frame: Immediately after each intervention
Emotional Breakthrough
Time frame: Immediately after each intervention
Mystical Experiences
Time frame: Immediately after each intervention
Change in perceived stress
Time frame: Baseline and 1-week after each intervention
Change in Pain Catastrophizing
Time frame: Baseline and 1-week after each intervention
Change in Depression
Time frame: Baseline and 1-week after each intervention
Persisting Effects
Time frame: 1-week after each intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Pratscher principal investigator
University of Missouri-Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Flotation-REST and Dark Room in people with Healthy and Chronic Pain, run by University of Missouri-Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: From baseline to follow-up, approximately 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.