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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Yoga and Mindfulness Skills

• Registration Number: NCT03752164
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-21
• Study First Posted: 2018-11-23
• Study Start: 2019-05-09
• Status Verified: 2019-09
• Primary Completion: 2019-09-12
• Study Completion: 2019-09-12
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• on medium to high doses of steroids and/or leukotriene inhibitors
• a Child-Asthma Control Test Score <21

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yoga and Mindfulness	Yoga and Mindfulness Skills	An intervention consisting of one session lasting 30 minutes where a certified yoga instructor teaches the children gentle yoga and mindfulness skills.

Primary Outcome Measures

Name	Time	Method
Tolerability: FEV1%(forced expiratory volume in 1 second ) asthma symptoms and adverse events	2 hours	whether intervention causes an exercise induced bronchoconstriction, asthma symptoms or adverse events

Secondary Outcome Measures

Name	Time	Method
Preliminary Effects: Change in FEV1	Baseline to 2 hours	measuring the change in FEV1 pre and post intervention

Trial Locations

Locations (1)

Children's Hospital of Richmond; 🇺🇸 Richmond, Virginia, United States