Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.

Not Applicable

Completed

• Conditions: Pain, Chronic
• Interventions: Device: PneuRIP; Other: biofeedback to assist with breathing

• Registration Number: NCT05791435
• Lead Sponsor: Nemours Children's Clinic

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.

Study Timeline

• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-03-30
• Study Start: 2023-06-05
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Youth with Chronic pain Prescribed yoga therapy as part of treatment plan

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Exclusion Criteria

• Otherwise healthy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biofeedback group	PneuRIP	This group will receive biofeedback to assist with breathing
Biofeedback group	biofeedback to assist with breathing	This group will receive biofeedback to assist with breathing
Non-Biofeedback group	PneuRIP	This group will only have their breathing monitored after instruction

Primary Outcome Measures

Name	Time	Method
Phase angle	8 weeks	Measures synchrony between chest and stomach

Trial Locations

Locations (1)

Nemours/A.I. duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States