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

NCT ID: NCT03752164

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-09
• Study Completion Date: 2019-09-12

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.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Yoga and Mindfulness Skills

Intervention Type: BEHAVIORAL

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

Interventions

Yoga and Mindfulness Skills

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Lack

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Children's Hospital of Richmond

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20014054

Identifier Type: -

Identifier Source: org_study_id