Contemporary Clinical Trials Communications (Jun 2023)
Scientific yoga module for hypothyroidism: A study protocol for tele-yoga RCT
Abstract
Background: Management of thyroid dysfunction has a direct effect on the quality of life and studies have recognized that hypothyroidism has become a public health challenge. Although conventional medicine is widely used, its long-term side effects are elucidated. This study aims to conduct a randomized controlled trial (RCT) through tele-mode to assess the effectiveness of the newly developed and validated “Scientific Yoga Module” as a telehealth concept for improving the quality of life in patients with hypothyroidism along with management of other symptoms as compared to the standard of care. Method: This is a single-blinded, two-arm, parallel-group RCT in which at least a total of 120 primary hypothyroid subjects both male and female between the age group 18 to 60 will be recruited from the database of Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA). Participants will be randomly divided into a yoga intervention group (n = 60) and a waitlist control group (n = 60) as per the inclusion and exclusion criteria of the study. A tele-yoga intervention for six months will be administered and pre-interim-post data will be recorded for both groups. This protocol is designed to study the effect of Scientific Yoga Module intervention on primary assessments of SF-36 scale [health-related quality of life (HRQOL) that includes physical, mental, emotional, and social states] along with secondary assessments on the biochemical test of thyroid profile-{Triiodothyronine (T3), Thyroxine (T4), Thyroid Stimulating Hormones (TSH)}, Body Mass Index (BMI), Blood Pressure (BP), Fatigue Assessment Scale (FAS), Perceived Stress Scale (PSS), Gita Inventory of personality scale (GIP). Conclusion: To the best of our knowledge, this tele-yoga RCT for hypothyroidism will be the first clinical trial to analyze the effectiveness of a “Scientific Yoga Module” imparted through tele-mode.
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