Relaxation Breathing Training for Children
NCT03271086 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2020-11-17
Summary
Family-centered Relaxation Breathing Training in the Pediatric Outpatient Clinic:
The long term goal is to apply simple, low cost, assistive technologies (heart rate variability \[HRV\] biofeedback together with mobile health tools) to teach relaxation breathing in the Boston Medical Center pediatric clinic setting following a trauma-informed care model. For this research both a mobile app for relaxation breathing skills and reminder text messages will be provided for the at-risk target population. The investigators will assess the feasibility and acceptability of relaxation breathing intervention in 60 parent-child dyads. These dyads will be randomly assigned to receive either (1) biofeedback relaxation training alone or (2) Technology-enhanced relaxation breathing (biofeedback relaxation training together with mobile health tools). Outcome measures will assess relaxation breathing practice, anxiety, and parental stress at the time of the intervention and at one month follow up.
Conditions
- Stress Disorder
- Biofeedback
Interventions
- BEHAVIORAL
-
The StressEraser
The StressEraser is a handheld biofeedback device that measures heart rate variability (HRV). Heart rate increases during inspiration and decreases during expiration. The HRV, depicted on a miniature screen, essentially represents respirations. The investigator's prior study demonstrated that the device is easily mastered and acceptable to children above 6 years of age.
- BEHAVIORAL
-
Breathe2Relax
Breathe2Relax is a free mobile app, developed by the Dept. of Defense's National Center for Telehealth and Technology to help veterans with PTSD and others use breathing practice for stress management. This application guides users in relaxation breathing and is available for both android and iOS phones. It is adapted for children 6 years and up. For instance, the cycles can be shortened for children, there is a selection of quiet music and the user can choose backgrounds for personalization.
- BEHAVIORAL
-
Reminder text messages
Weekly texts will be sent out to parents in the technology-enhanced relaxation breathing group to as reminders to practice the daily relaxation breathing with their child.
Sponsors & Collaborators
-
Boston Medical Center
lead OTHER
Principal Investigators
-
Naomi Steiner, MD · Boston Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-31
- Primary Completion
- 2021-12-31
- Completion
- 2021-12-31
Countries
- United States
Study Locations
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