Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma (K2B2)



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:7 - 11
Updated:2/9/2019
Start Date:May 2019
End Date:December 2019
Contact:Sharon Lack
Email:lacks2@vcu.edu
Phone:804-828-9140

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Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma

This proposed pilot study will examine the tolerability, feasibility, acceptability, and
preliminary effects of a gentle yoga intervention "Kids 2 Be & Breathe" (K2B2; a manualized
30 minute gentle yoga and mindfulness session held one-on-one) in urban children aged 7-11
with severe asthma.

Pre-Intervention Assessment: permission/assent from the child and consent of the
parent/guardian will be obtained and initial data and measurements will be collected to
ensure continued eligibility; baseline measures will be assessed.

Intervention: participants will engage in a one-time manualized, age appropriate, 1:1,
30-minute intervention involving gentle yoga and mindfulness techniques in a private room in
the Pediatric Research Unit at the Children's Hospital of Richmond. The intervention will be
taught by certified and experienced child yoga instructors who have been trained in the study
protocol by the applicant. These yoga instructors collaborated with the interdisciplinary
research team in the development of manualized age-appropriate yoga sequences.
Parents/guardians will be invited to observe the yoga session. Intervention fidelity will be
maintained through the use of a manualized intervention and the PI observing all sessions for
manual consistency. The intervention will cease if the participant suffers from any asthma
symptoms during the intervention, such as wheezing, coughing, retractions, accessory muscle
use, chest tightness or shortness of breath, or experiences any other adverse events which
precludes the his or her ability to actively participate in the intervention.

Post-Intervention Assessment: upon completion of the intervention, brief semi-structured
interviews will be conducted with the child and parent/guardian separately in order to
explore the acceptability of the intervention and the PI will again assess the child for any
asthma symptoms or adverse events. Post-intervention pulmonary function test and vital sign
measurements will then be collected.

Inclusion Criteria:

- on medium to high doses of steroids and/or leukotriene inhibitors

- a Child-Asthma Control Test Score <21

Exclusion Criteria:

- inability to speak English (child); inability to read/write English (parent/guardian)

- child hospitalized in past two weeks for their asthma

- current illness associated with oral temperature >100.4

- pulse ox <95% and/or any wheezing, retractions or accessory muscle use
We found this trial at
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Richmond, Virginia 23298
Phone: 804-867-6024
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Richmond, VA
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