Background and Rationale

Sickle cell anemia is a prevalent hemolytic disorder in Indian populations, particularly in Central India. Women with sickle cell disease (SCD) suffer both disease-related complications and unique challenges regarding reproductive health, chronic pain, and social functioning. Standard management includes hydroxyurea, pain control, and community interventions, yet frequent vaso-occlusive crises and chronic pain impair life quality. Complementary approaches such as yoga have shown promise for pain reduction, inflammation control, and holistic health support—especially important for women, who may face gaps in conventional care and awareness. This study addresses the need for integrated, evidence-based strategies to enhance self-care, literacy, and psychosocial outcomes among women with SCD. The Objectives of the study are to assess whether a yoga-integrated health empowerment program significantly improves health literacy, biophysical and biochemical markers (including chronic pain scores and inflammation), and quality-of-life indicators, To explore the relationships among health literacy, physical markers, biochemical markers, and quality of life in women with SCD. Methodology: This is a randomized controlled trial (RCT) with two parallel arms: (1) standard medical treatment including hydroxyurea, and (2) standard treatment plus a structured yoga-based health empowerment program. Women aged 18–45 years with clinically proven SCD and stable conditions, who experience chronic pain and possess digital access, will be recruited through the Sickle Cell OPD at AIIMS Nagpur. The yoga module consists of supervised in-person and virtual sessions (pranayama, asana, relaxation) twice weekly, supplemented by ongoing health education (printed and digital materials) on disease management, self-care, and coping strategies. Baseline and post-intervention assessments (at week 13) include validated questionnaires for health literacy, pain score (VAS), quality of life (ASCQ-Me), biophysical measurements, and laboratory testing for inflammatory markers (CRP, TNF-alpha). The total planned sample size is 100 women (50 per group), with tools and procedures detailed for randomization, allocation concealment (SNOSE method), and blinding of assessors where feasible. Careful strategies support intervention adherence, including daily virtual contact, WhatsApp groups, appointment reminders, and family engagement. Adverse events are monitored, with clear criteria for intervention discontinuation and ongoing follow-up for all participants, including post-study care offered to controls. The primary outcomes of the study are mean changes in health literacy, biophysical and biochemical markers, and quality of life over three months. Secondary outcomes include reductions in vaso-occlusive crisis frequency, analgesic requirements, and hospital admissions. Data will be analyzed using intention-to-treat principles, with t-tests, ANCOVA, correlation, and regression analyses applied. All procedures meet ethical standards with informed consent, confidentiality, and IEC oversight. This study innovatively combines yoga therapy with health literacy and empowerment training for women with SCD—a population experiencing high burdens yet low awareness and support. Its rigorous design, validated tools, and strong outcome focus position it to yield actionable insights for integrative, gender-sensitive chronic disease care and policy in India.