Effect of yoga practice on health related quality of life at 12 weeks in paediatric haemat-oncological patients aged 3-18 years and their caregivers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Primary outcome is change in health related quality of life by PedsQOL 4.0 for patients and parents
研究概览
简要总结
Study Design- Quasi experimental study
Study duration- June 2025 to November 2026.
Intervention period- 12-week period, with pre- and post-intervention assessments.
**Study Setting-**The study will be conducted in the Paediatric haemato-oncology clinic and Paediatric ward in the Department of Paediatrics with a dedicated yoga instructor at the Employee State Insurance Corporation (ESIC) Model Hospital and PGIMSR, Basaidarapur, New Delhi in collaboration.
Sample Size
Taking the study by Bisht et al as the parent study, the sample size will be determined based on a power analysis, aiming to detect a moderate effect size (Cohen’s d = 0.5) with 80% power and a significance level of 0.05. A minimum of 40 patient-caregiver dyads ( a total of 80 subjects) will be enrolled, accounting for a 20% dropout rate.
Bisht et al studied the impact of yoga based lifestyle intervention (YBLI) on psychological stress and quality of life in the parents of children with retinoblastoma with a sample size of 86 (43 dyads of both parents of retinoblastoma patients.) The study concluded that YBLI improves overall health and QOL and reduces psychological stress experienced by the parents of retinoblastoma patients.
Sampling Technique
A consecutive sampling method will be used. Eligible participants will be enrolled during routine outpatient or inpatient visits over a recruitment period of 15 months (leaving 3 months for follow-up).
InterventionParticipation will consist of practicing of yoga for 12 weeks, consisting of: Frequency of yoga practice is 5 sessions per week as per convenience of patients and parents at their home. Duration of yoga is 10-30 minutes per session (less than 10 years – 10 minutes; greater than10 years-30 minutes) . Patients will be asked to do Age-appropriate asanas (postures), pranayama (breathing exercises), and guided meditation. Sessions will be age and appropriate for disease stage. Sessions will be led by certified yoga therapist and will be taught to the parents. Monitoring of compliance by keeping record of diary daily and video calls 3 times per week and interviewed physically 3 weekly.
Data CollectionDemographic and clinical data (diagnosis, treatment phase, etc.) will be collected from medical records. Participants will complete questionnaires under supervision at two time points.. HRQoL assessments will be conducted at baseline (Week 0) and post-intervention (Week 12). If yoga is delayed due to any issue, the final assessment will be done at completion of 12 weeks of yoga therapy.
Statistical AnalysisThe data collected will be entered in Microsoft Excel and the analyses will be done using Statistical Package for Social Sciences (SPSS) version 25.0. Descriptive statistics will be used to summarize the demographic and clinical variables. The discrete variables will be presented as frequency and percentages whereas the continuous variables will be presented as mean (SD) or median (IQR). Paired t-tests (or Wilcoxon signed-rank tests for non-parametric data) will be used to assess within-group differences. Independent t-tests (or Mann–Whitney U tests) will be used to compare between-group differences. Multivariate linear regression will be used to control for confounders (e.g., age, treatment type). Significance will be set at p less than 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects diagnosed with oncological or chronic haematological conditions undergoing active treatment such as chemotherapy, radiotherapy, blood transfusions, factor replacement, chelation therapy, and post-treatment monitoring etc or survivors of childhood cancer conforming to the following 1 At least one parent or primary caregiver of each participating child is available 2 At least one caregiver and/or the child is able to comprehend the technique of yoga and respond to questionnaires.
排除标准
- •1 Patients with medical conditions or contraindications to physical activity such as hemodynamically unstable, dyselectrolytemia, febrile neutropenia, platelet count less than 50000 per µL or with bleeding, haemoglobin less than 7 g per dL, bone or soft tissue injury, tumour lysis syndrome, intercurrent infection etc 2 Severe cognitive or psychiatric disorder in child or primary caregiver that hinder participation.
- •3 Previous regular yoga practice in the patient or caregiver in last 6 months.
结局指标
主要结局
Primary outcome is change in health related quality of life by PedsQOL 4.0 for patients and parents
时间窗: Baseline and at 12 weeks
次要结局
- Secondary outcome is change in parental stress by perceived stress scale(Baseline and at 12 weeks)
- Change in child stress and anxiety by Revised Children’s Anxiety and depression(scale 25)
研究者
K Prasanna Venkatesh
ESIC PGIMSR Hospital