NCT03271086

Relaxation Breathing Training for Children

Family Centered Relaxation Breathing Training in the Pediatrics Outpatient Clinic

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After consent is signed, a baseline questionnaire will be given to the participant, including demographics and baseline data followed by randomization into one of the following groups:Relaxation breathing training alone or Technology-enhanced relaxation breathing.The intervention will occur through the use of the StressEraser, Breathe2Relax and text messaging. 1. The StressEraser is a handheld biofeedback device that measures heart rate variability (HRV). Heart rate increases during inspiration and decreases during expiration. This HRV, depicted on a miniature screen, essentially represents respirations. We have been using this device in the pediatric outpatient department over the past two years (in a non research entity) and it has been well accepted by children 6 years of age and above. In our prior study, which took place in school, the device was also easily mastered and acceptable to children above 6 years of age. 2. 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. The user downloads the app. and is walked through steps that easily explain the purpose of the app (to guide relaxation breathing). The active part of the app shows a tube that fills in during inspiration and empties during expiration. For children the cycle lengths can be shortened which is explained to participating parents by the research team. There is a selection of quiet music and the user can choose backgrounds for personalization. The Breath2Relax app will be downloaded for the RT-enhanced group at the time of the intervention for the RT-enhanced group, and the parent will be shown how to modify the length of the breath cycle depending on their child's age. 3. Text messages: Weekly texts will be sent out to parents in the RT-enhanced group regarding relaxation breathing and to remind parents to practice the daily relaxation breathing with their child. For the breathing training, the study research assistant (RA) will follow the standardized protocol used in BMC pediatric clinic over the past two years. The child is taught firstand learns how to use relaxation breathing and then the child teaches their parent how it works with the support of the RA. This step assures that the child has learned the relaxation breathing skills and also creates a moment when relaxation breathing is practiced together by the dyad. The parent-child dyad are encouraged to practice relaxation breathing once daily.Caregivers usually choose bedtime to practice breathing because the practice can be done while the child is in bed. The training is followed for the Technology-enhanced relaxation breathing group by downloading the Breath2Relax app on the parent's smartphone. Parents will be prompted by the RA to choose a specific time each day to practice the relaxation breathing with their child, and for the Technology-enhanced relaxation breathing group using the Breath2Relax app.

Conditions

• Stress Disorder
• Biofeedback

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2017-09-01
• Last updated: 2020-11-17

Locations

1 site across 1 country: United States