Trial Outcomes & Findings for Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients (NCT NCT04720053)
NCT ID: NCT04720053
Last Updated: 2024-09-03
Results Overview
Wide pain index (WPI) defined as a 4-quadrant plus axial pain, measuring widespread pain in 19 body areas where the patient feels pain over the prior week. Each area identified on the list counts as 1. The range on the WPI score can range from 0 to 19. With lower number indicating fewer areas of pain (hence lower pain). The difference is calculated by taking the baseline score minus the end of treatment score.
COMPLETED
NA
41 participants
Baseline to end of treatment (day 90)
2024-09-03
Participant Flow
Potential participants were patients diagnosed with fibromyalgia at a large healthcare facility in the Midwestern United States. Enrollment took place from November 01, 2021 to January 27, 2023. Study participation concluded on July 28, 2023.
After consent, one participant was found not to meet study entry criteria (no mobile device) and had to be removed from study.
Participant milestones
| Measure |
Wearable Brain Sensing Wellness Device Headband System
Subject diagnosed with fibromyalgia at Mayo Clinic GIM Fibromyalgia Clinic will receive a wearable brain sensing wellness device headband system, and will be given a demonstration of the mindfulness sessions, with detailed instructions on how to begin each session.
Wearable brain sensing wellness device headband system: Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Wearable Brain Sensing Wellness Device Headband System
Subject diagnosed with fibromyalgia at Mayo Clinic GIM Fibromyalgia Clinic will receive a wearable brain sensing wellness device headband system, and will be given a demonstration of the mindfulness sessions, with detailed instructions on how to begin each session.
Wearable brain sensing wellness device headband system: Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
Baseline Characteristics
Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients
Baseline characteristics by cohort
| Measure |
Wearable Brain Sensing Wellness Device Headband System
n=40 Participants
Subject diagnosed with fibromyalgia at Mayo Clinic GIM Fibromyalgia Clinic will receive a wearable brain sensing wellness device headband system, and will be given a demonstration of the mindfulness sessions, with detailed instructions on how to begin each session.
Wearable brain sensing wellness device headband system: Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
|
|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex/Gender, Customized
male
|
6 Participants
n=5 Participants
|
|
Sex/Gender, Customized
female
|
33 Participants
n=5 Participants
|
|
Sex/Gender, Customized
other
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of treatment (day 90)Population: Those with complete data at both baseline and end of treatment (day 90)
Wide pain index (WPI) defined as a 4-quadrant plus axial pain, measuring widespread pain in 19 body areas where the patient feels pain over the prior week. Each area identified on the list counts as 1. The range on the WPI score can range from 0 to 19. With lower number indicating fewer areas of pain (hence lower pain). The difference is calculated by taking the baseline score minus the end of treatment score.
Outcome measures
| Measure |
Wearable Brain Sensing Wellness Device Headband System
n=28 Participants
Subject diagnosed with fibromyalgia at Mayo Clinic GIM Fibromyalgia Clinic will receive a wearable brain sensing wellness device headband system, and will be given a demonstration of the mindfulness sessions, with detailed instructions on how to begin each session.
Wearable brain sensing wellness device headband system: Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
|
|---|---|
|
Change in Widespread Pain Index (WPI)
|
1.4 units on a scale
Standard Deviation 2.8
|
PRIMARY outcome
Timeframe: Baseline to end of treatment (day 90)Population: Participants with measurements at both baseline and end of treatment (day 90)
Measured on a 0-10 pain assessment scale. Participants rate their stress on a scale of 0 to 10. Zero means "no stress," and 10 means "the worst possible stress". The difference is calculated by taking the baseline score minus the end of treatment score.
Outcome measures
| Measure |
Wearable Brain Sensing Wellness Device Headband System
n=30 Participants
Subject diagnosed with fibromyalgia at Mayo Clinic GIM Fibromyalgia Clinic will receive a wearable brain sensing wellness device headband system, and will be given a demonstration of the mindfulness sessions, with detailed instructions on how to begin each session.
Wearable brain sensing wellness device headband system: Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
|
|---|---|
|
Change in Perceived Stress Scale
|
4.1 units on a scale
Standard Deviation 6.04
|
Adverse Events
Wearable Brain Sensing Wellness Device Headband System
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place