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

Virginia Commonwealth University15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

Yoga and Mindfulness SkillsBEHAVIORAL

Single brief session in which children are taught yoga and skills in mindfulness

Eligibility

Sex: ALLMin age: 7 YearsMax age: 11 Years

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Richmond

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Tolerability: FEV1%(forced expiratory volume in 1 second ) asthma symptoms and adverse events

whether intervention causes an exercise induced bronchoconstriction, asthma symptoms or adverse events

Time frame: 2 hours

Secondary Outcomes

Preliminary Effects: Change in FEV1

measuring the change in FEV1 pre and post intervention

Time frame: Baseline to 2 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.