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

NCT05791435 | Completed Results

• 2 other identifiers: 19040793R41AT012155-01S1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• Phase Angle

  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.

  8 weeks

Study Arms (2)

Biofeedback group

EXPERIMENTAL

This group will receive biofeedback to assist with breathing

Device: PneuRIP; Other: biofeedback to assist with breathing

Non-Biofeedback group

EXPERIMENTAL

This group will only have their breathing monitored after instruction

Device: PneuRIP

Interventions

PneuRIP DEVICE

Measuring respiratory indices through Respiratory Inductance Plethysmography

Also known as: Non-invasive breathing monitor

Biofeedback group; Non-Biofeedback group

biofeedback to assist with breathing OTHER

Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen

Biofeedback group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Otherwise healthy

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours/A.I. duPont Hospital for Children

Wilmington, Delaware, 19899, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Respiration

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Tariq Rahman
• Organization: Nemours Children Health System

trahman@nemours.org

302 651 6831

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Engineer

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: May 1, 2023
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)