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Clinical Trial Summary

The proposed project will examine feasibility and preliminary efficacy of a yoga intervention in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC) and includes two parts: (1) a survey of children and parents regarding preferences (e.g., convenient days/times), experiences and expectations regarding yoga (including barriers and positive expectancies) and (2) an eight week clinical trial of a yoga intervention in 10 pairs of children and parents.


Clinical Trial Description

The specific aims and hypotheses for this seed grant are to collect and assess data on:

Aim 1 feasibility - perceived barriers/solutions, interest and accrual rates, attendance per session, participant retention, evidence of institutional support and resource commitment Hypothesis 1: A yoga intervention is feasible among pediatric oncology patients and their parents; (2) preliminary efficacy - including effect sizes for calculating power Hypothesis 2a: A yoga intervention improves pediatric oncology patients' fatigue, QOL, and sleep.

Hypothesis 2b: A yoga intervention improves parental QOL and caregiver burden.

We will be using the following questionnaires and scales to help answer the quesitons related to the hypotheses and aims:

PedsQL 4.0 PedsQL 3.0 Cancer Module The Fatigue Scale SleepDiary Actigraphy data. Child Home Yoga Practice Diary Satisfaction survey

Questionnaires noted below are given only to the parents:

SF-12 Zarit Caregiver Burden Index Yoga Satisfaction Survey

Study participants will have 4 yoga sessions and the questionnaires and surveys are done prior to the first yoga session and after the last yoga session.

The yoga sessions are created with both the study participant and a certified yoga instructor. The patients are given the yoga routine to practice at home at their leisure. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02899117
Study type Interventional
Source Connecticut Children's Medical Center
Contact
Status Completed
Phase N/A
Start date August 2014
Completion date January 2017

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