Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.
Primary Purpose
Pain, Chronic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PneuRIP
biofeedback to assist with breathing
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Chronic
Eligibility Criteria
Inclusion Criteria: Youth with Chronic pain Prescribed yoga therapy as part of treatment plan Exclusion Criteria: Otherwise healthy
Sites / Locations
- Nemours/A.I. duPont Hospital for Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Biofeedback group
Non-Biofeedback group
Arm Description
This group will receive biofeedback to assist with breathing
This group will only have their breathing monitored after instruction
Outcomes
Primary Outcome Measures
Phase angle
Measures synchrony between chest and stomach
Secondary Outcome Measures
Full Information
NCT ID
NCT05791435
First Posted
March 17, 2023
Last Updated
October 10, 2023
Sponsor
Nemours Children's Clinic
1. Study Identification
Unique Protocol Identification Number
NCT05791435
Brief Title
Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.
Official Title
Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This project will develop and test a wearable breathing monitor that will measure the synchrony in breathing between the diaphragm and chest of children with a pain diagnosis while receiving yoga therapy. Specifically, we will develop a biofeedback system to help improve breathing in pain patients.
Detailed Description
This Small Business Technology Transfer (STTR) Phase I application proposes the development and trial of a novel non-invasive real-time breathing sensor - pneuRIP- to show the beneficial effects of respiratory biofeedback on yoga. PneuRIP will be employed to monitor and improve asana (posture) and pranayama (breathing) in yoga in youth with chronic pain. The sensor consists of two inductive bands worn around the chest and abdomen that measure and differentiate diaphragmatic and chest breathing through Respiratory Inductance Plethysmography (RIP). Readings are recorded and analyzed on a small chest-worn unit and wirelessly transmitted to an iPad. Measures include the phase angle between the chest and abdomen; percentage breathing through the ribcage; respiratory rate; and labored breathing index. This sensor takes little time to set up and readings are provided instantaneously.
The first part of the proposal will develop the biofeedback software. The biofeedback component will be related to the synchrony between diaphragmatic and chest breathing, and the relative depth of breathing. This information will be presented to the user visually on an iPad screen in the form of 2 moving bars - one corresponding to the chest and one to the belly.
In the second part of the study, we will test the pneuRIP with biofeedback with 20 youth with pain enrolled in an interdisciplinary pediatric chronic pain program in a large pediatric hospital receiving yoga as one of the therapies. The yoga regimen is 8 sessions, once per week. Subjects will be randomized into two groups: one receiving instruction only on synchronous breathing; the second group will receive biofeedback in addition. Outcomes will be standardized measures of pain (recorded before and after entire regimen) and breathing indices (recorded during each session). Outcomes will inform the feasibility of using real-time biofeedback in yoga with a non-invasive respiratory monitor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biofeedback group
Arm Type
Experimental
Arm Description
This group will receive biofeedback to assist with breathing
Arm Title
Non-Biofeedback group
Arm Type
Experimental
Arm Description
This group will only have their breathing monitored after instruction
Intervention Type
Device
Intervention Name(s)
PneuRIP
Other Intervention Name(s)
Non-invasive breathing monitor
Intervention Description
Measuring respiratory indices through Respiratory Inductance Plethysmography
Intervention Type
Other
Intervention Name(s)
biofeedback to assist with breathing
Intervention Description
Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen
Primary Outcome Measure Information:
Title
Phase angle
Description
Measures synchrony between chest and stomach
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Youth with Chronic pain Prescribed yoga therapy as part of treatment plan
Exclusion Criteria:
Otherwise healthy
Facility Information:
Facility Name
Nemours/A.I. duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19899
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.
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