Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma (K2B2) (K2B2)
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|ClinicalTrials.gov Identifier: NCT03752164|
Recruitment Status : Completed
First Posted : November 22, 2018
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Behavioral: Yoga and Mindfulness Skills||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Kids 2 Be & Breathe: A Study on the Use of Yoga and Mindfulness in Children With Severe Asthma|
|Actual Study Start Date :||May 9, 2019|
|Actual Primary Completion Date :||September 12, 2019|
|Actual Study Completion Date :||September 12, 2019|
Experimental: Yoga and Mindfulness
An intervention consisting of one session lasting 30 minutes where a certified yoga instructor teaches the children gentle yoga and mindfulness skills.
Behavioral: Yoga and Mindfulness Skills
Single brief session in which children are taught yoga and skills in mindfulness
- Tolerability: FEV1%(forced expiratory volume in 1 second ) asthma symptoms and adverse events [ Time Frame: 2 hours ]whether intervention causes an exercise induced bronchoconstriction, asthma symptoms or adverse events
- Preliminary Effects: Change in FEV1 [ Time Frame: Baseline to 2 hours ]measuring the change in FEV1 pre and post intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752164
|United States, Virginia|
|Children's Hospital of Richmond|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Sharon Lack||Virginia Commonwealth University|