Yogic interventions as a complementary therapy for chronic rhinosinusitis in children A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 192
- 试验地点
- 1
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of a structured yoga module as a complementary therapy in children aged 5–18 years diagnosed with chronic rhinosinusitis (CRS). Prior approvals will be obtained from IPAC, IEC, and CTRI.
Eligible children attending the Paediatric OPD will be screened based on predefined criteria after obtaining written parental consent and child assent. Baseline assessment will include demographic data, medical history, and symptom evaluation using TNSS and SN-5 questionnaires. Participants will be randomized using computer-generated SNOSE technique into Control Group Standard medical care as prescribed.
Intervention Group Standard care plus a structured yoga module (asana, pranayama, and relaxation), developed through expert opinion.
The yoga intervention includes one initial supervised session followed by home practice (20 minutes/session, 4 days/week for 3 months), with bi-weekly live interactive monitoring and telephonic follow-ups for adherence and safety. A printed instruction booklet will be provided. Final assessment will be conducted at Week 12 using TNSS and SN-5.
Secondary objectives include: • Development and distribution of a structured online KAP questionnaire among pediatricians and ENT specialists across India to assess knowledge, attitude, and practices regarding CRS and yoga. • Qualitative assessment of barriers, acceptability, and challenges in implementing yoga among children with CRS and their parents.
Statistical analysis will be performed for quantitative data, and qualitative insights will be systematically documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 5.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children diagnosed with Chronic Rhinosinusitis According to EPOS guidelines Symptom duration less then twelve weeks despite standard medical treatment.
排除标准
- •History of nasal or sinus surgery.
- •Major orthopaedic injuries prohibiting the performance of various yoga postures Patients with known mental retardation and inability to practice yoga.
- •Individuals with K/C/O primary ciliary dyskinesia, immunodeficiency, craniofacial anomalies, and cystic fibrosis K/C/O bronchial asthma on medication.
研究者
Dr Athmika Shetty
Division of Yoga, Centre for Integrative Medicine and Research, Manipal, Manipal Academy of Higher Education, Manipal