Trial Outcomes & Findings for Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain. (NCT NCT05791435)
NCT ID: NCT05791435
Last Updated: 2025-01-13
Results Overview
Measures synchrony between chest and stomach. The phase angle is measured in degrees. If the chest and stomach move together then the phase angle is zero degrees. If they were to move in opposite directions the phase angle would be 180 degrees.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-01-13
Participant Flow
Recruited in Medical clinic. Dates are 5/1/23-8/29/23
Participant milestones
| Measure |
Biofeedback Group
This group will receive biofeedback to assist with breathing
PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography
biofeedback to assist with breathing: Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen
|
Non-Biofeedback Group
This group will only have their breathing monitored after instruction
PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.
Baseline characteristics by cohort
| Measure |
Biofeedback Group
n=7 Participants
This group will receive biofeedback to assist with breathing
PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography
biofeedback to assist with breathing: Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen
|
Non-Biofeedback Group
n=7 Participants
This group will only have their breathing monitored after instruction
PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.14 years
STANDARD_DEVIATION 2.79 • n=5 Participants
|
16.57 years
STANDARD_DEVIATION 1.27 • n=7 Participants
|
15.36 years
STANDARD_DEVIATION 2.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksMeasures synchrony between chest and stomach. The phase angle is measured in degrees. If the chest and stomach move together then the phase angle is zero degrees. If they were to move in opposite directions the phase angle would be 180 degrees.
Outcome measures
| Measure |
Biofeedback Group
n=7 Participants
This group will receive biofeedback to assist with breathing
PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography
biofeedback to assist with breathing: Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen
|
Non-Biofeedback Group
n=7 Participants
This group will only have their breathing monitored after instruction
PneuRIP: Measuring respiratory indices through Respiratory Inductance Plethysmography
|
|---|---|---|
|
Phase Angle
|
58 degrees
Standard Deviation 13.65
|
41 degrees
Standard Deviation 12.17
|
Adverse Events
Biofeedback Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Biofeedback Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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