Flotation-REST for Chronic Pain, Stress, and Sleep

Healthy Clinical Trial

Official title:

Daily Assessments of Pain, Stress, and Sleep Following Flotation-REST: A Randomized Crossover Trial for Those With Chronic Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04155268
• Other study ID #: 2017263
• Status: Withdrawn
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: September 8, 2020

Study information

• Verified date: September 2020
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 8, 2020
• Est. primary completion date: September 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Healthy
• Musculoskeletal Pain

Intervention

Behavioral:
• Flotation-REST
Floating in a specialized device (float pod or float cabin) used to attenuate sensory input.
• Dark Room
Participants will lay on an air mattress in a dark room with no cell phone and reduced sensory input.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Change in daily pain intensity where higher scores represent greater pain reduction using the Brief Pain Inventory	From baseline to follow-up, approximately 2 weeks
Primary	Pain Unpleasantness	Change in daily pain unpleasantness where higher scores represent greater pain unpleasantness using the Brief Pain Inventory.	From baseline to follow-up, approximately 2 weeks
Primary	Stress	Changes in perceived stress scale and daily diary assessments of stress where higher scores represent higher levels of stress.	From baseline to follow-up, approximately 2 weeks
Primary	Sleep	Sleep Health Index and daily electronic dairies will be used to record sleep parameters. Higher sleep quality represents better sleep.	From baseline to follow-up, approximately 2 weeks
Secondary	Change in pain interference	Change in daily pain interference where higher scores represent interference in daily activities from pain using the Brief Pain Inventory.	From baseline to follow-up, approximately 2 weeks
Secondary	Change in muscle tension or tightness	Average change in muscle tension from pre- to post-intervention where higher scores indicate greater muscle tension.	Immediately before and after each intervention
Secondary	Change in self-actualization from baseline	Self-actualization Scale; 5-point Likert-type scale where the highest score indicates strongest self-actualization	Baseline, 1- week and 1-month after intervention
Secondary	Interoception	Self-reported interoception assessed with the Multidimensional Interoceptive Awareness Scale after each intervention where higher scores indicate greater interoception during the session.	Immediately after each intervention
Secondary	Insight	Self-reported insights assessed with the Psychological Insight Questionnaire after each intervention where higher scores indicate more insight occurred during the session.	Immediately after each intervention
Secondary	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.	Immediately after each intervention
Secondary	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.	Immediately after each intervention
Secondary	Change in perceived stress	Perceived Stress Scale; assesses changes in perceived stress where higher scores indicate greater levels of stress	Baseline and 1-week after each intervention
Secondary	Change in Pain Catastrophizing	Pain Catastrophizing Scale; assesses changes in pain catastrophizing where higher scores indicate greater levels of pain catastrophizing	Baseline and 1-week after each intervention
Secondary	Change in Depression	Becks Depressive Inventory II; assesses changes in depression where higher scores indicate greater levels of depression	Baseline and 1-week after each intervention
Secondary	Persisting Effects	Persisting Effects Questionnaire: scale of 0 - 5 where 5 is the strongest persisting effect	1-week after each intervention