A descriptive, systematic work of developing an IAYT yoga module to treat hypothyroidism was initiated. This work is part of a bigger study for which ethical clearance was obtained by S-VYASA University vide number RES/IEC-SVYASA/137/2019. A pre-post two group intervention study which will be conducted in due course.

Hypothyroid condition anchored in pancha kosha concept (five layers of human existence) as stated in Thaittiriya Upanishad, the module addresses the issues related to hypothyroidism at physical, psychological, social and spiritual domains. The yogic techniques proposed in the module intended to be learnt and practiced in a period of three months with 90 minutes session of supervised practice per day and five days in a week.

Kosha wise techniques that are known to be effective for managing hypothyroid condition are considered for development of IAYT program. In order to bring variation, to eliminate monotonous feeling and also to manage the time, practice of techniques is taught to each participant depending on ability to do and learn. In general the 90 minutes session includes loosening exercises- head to toe coving all major joints, Suryanamaskars (6-12 rounds), standing asanas (2 no’s), sitting asanas (2 no’s), prone asanas (2 no’s), supine asanas including inverted postures (4 no’s), Pranayama’s (2 no’s), meditation (1 no) and relaxation techniques (3 types).

Module development process was carried out in three steps.

Step 1: Construction of the module

Considering the clinical features of hypothyroidism, its pathways and the principles of IAYT, a structured set of yogic practices were listed out along with a brief note [Table/Fig-1]. In particular the focus was mainly drawn considering yogic techniques that reap specific benefits as detailed below.

The yogic techniques were identified based on the thorough review of yogic texts and scientific papers related to hypothyroid condition [1,5,6]. The draft module contained details of the yogic technique, recommended number of rounds of practice and also approximate time taken to practice. Against each technique, necessary justifications were provided based on referring to scientific papers, various yogic texts [7-10], expert consultation and empirical knowledge. It also included columns (five-point Likert) to indicate the relevance and comments against each technique. Column 1-not relevant; 2-little relevant; 3-moderately relevant; 4-very relevant; 5-extremely relevant. The module also had a section at the end to provide the comments of reviewer. Detailed module with yogic practices relevant to each sheath is provided in [Table/Fig-1]:

Step 2: Validation of the module

Fifty Subject Matter Experts (SMEs) were approached requesting to validate the model. Ten medical practitioners declined due to paucity of time. Four yoga experts did not return the form. In total, the module was validated by 36 SMEs which included six yoga experts (four PhD yoga scholars and two yoga experts with more than 15 years of experience), 10 medical practitioners (allopathy, ayurveda and naturopathy), eight researchers (MDs and PhDs), 12 yoga therapists (M.Sc./DYT in yoga therapy). Written consent was obtained from all the experts who validated the module. Face validity, content validity and relevance of each technique was obtained from each expert.

Step 3: Analysis of the data

The data obtained from the 36 experts was analysed and CVR and average of mean, mode and median of relevance scores using SPSS software version 23. Content Validity Ratio (CVR) was calculated using formula CVR=(Ne-N/2)/(N/2), where Ne is the number of panelists indicating ‘essential’ and N is the total number of panelists. Standard deviation and mean and standard deviation of mean, median and mode was also calculated. The techniques which had CVR ratio <0.5 and/or average of mean, median and mode <4 were excluded. These low value results are starred. Cronbach alpha value was calculated to assess the internal consistency.

The validated module was administered to a group of 35 women with hypothyroid condition as a pilot study to assess the acceptance and feasibility of performing the postures and other yogic techniques. The women aged between 25-50 years, having clinically diagnosed hypothyroidism and were under either allopathic or ayurvedic or homeopathic treatment were considered for this feasibility check. Women who had any surgery done in the last six months, pregnant women and who have physical impairment or medical conditions that interfere in administration of tools or IAYT yoga module were excluded from the study. Written consent was obtained from each participant. All the participants were able to perform all the practices under supervision. The duration to perform each technique was also assessed which is in line with the suggested duration against each technique. The study conducted at reputed yoga institution.

Out of the 53 techniques evaluated, 41 items scored either CVR more than 0.5 and/or average of mean, median and mode more than 4. (CVR score less than 0.5 in 11 items and average was less than 4 in one item). In total 12 items were excluded from the list. The final module included all techniques other than the scores that are starred in [Table/Fig-2]. Internal consistency calculated using Cronbach’s Alpha for the final 41 items, recorded 0.904. The final module includes the following IAYT techniques are, Breathing Exercise: Dog Breathing, Tiger Breathing, Shashankasana Breathing.Loosening Exercise: Forward and backward bending, Lateral bending, Twisting, Pavanmuktasana Kriya, Neck bending, Suryanamaskaras Asanas: Ardakati chakrasana, Trikonasana, Yoga Mudrasana, Navasana, Pascimottanasana, Janu shirshasana, Ustrasana, Bujangasana, Makarasana, Setubandasana, Sarvangasana, Matsyasana, Ustrasana. Kriyas: Jalaneti, Vamana dhauthi.Yogic Diet,Pranayama:Ujjayi, Bhastrika, Nadishuddi, Bhramari, Suryabedana, Vibagiya Swasha and Nadanusandana. Mudras: Viparita Karani. Bandas: Jalandarabanda and Uddiyana banda.Meditations:Om Meditations. Opening and closing prayers, Yogic counseling, Instant Relaxation Technique, Quick Relaxation Technique and Deep relaxation Technique.

In general, yoga is a holistic and integrated therapeutical approach that integrates physical, psychological, social and spiritual components of health and wellbeing. It is regarded as a form of mind body remedy to develop factors of fitness, mainly stress related ailments [1,5,6,11]. Normal practice of yoga is thought to beautify muscular power and body flexibility, promote and progress respiration and cardiovascular feature, helps in recovery and treatment of depression, addiction, anxiety, and reduce stress and strain and chronic ache, improve quality of sleep, and beautify total wellbeing and quality of existence [12].

Empirical knowledge and therapeutical benefits of certain yogic practices are known for enhancing the functioning of thyroid glands, gut and liver. Yogic practice also provides relaxation to body which brings calmness in the mind and reduces the stress. Yoga also promotes balanced lifestyle and diet [4,8-12]. The present work of developing yoga module for hypothyroidism involves through understanding of anatomical and physiological dynamics of hypothyroid condition in order to select appropriate yogic techniques to manage hypothyroid condition [4,6,8-10].

The developed IAYT program to treat/manage hypothyroid condition comprises of yogic techniques that addresses the issues related to hypothyroid condition at different koshas or sheaths. It is a holistic and integrated program. The novelty of this module development process relayed on understanding the anatomy, physiology, pathways and dynamics of hypothyroid condition and identifying appropriate yogic technique considering all the koshas to address the issues in a holistic way ([Table/Fig-1] and [Table/Fig 2]). Thyroid is one among the most common diseases prevalent in the recent years and is more commonly seen in women. With early diagnosis and treatment, one can manage symptoms like weight gain, fatigue, increased sensitivity to cold, constipation etc., and prevent complications like heart problems, mental health issues, infertility, birth defects etc., [4,5,13].

Yoga which started as a complementary therapy is slowly progressing towards considering it as an alternative therapy for many health conditions like low back pain, asthma, diabetes mellitus, high blood pressure etc. In this direction, it becomes essential and important to focus on customising or developing a validated yoga module for specific health conditions. To study the effect of yoga on thyroid dysfunction, very few studies are available [1,5,6,13,14,15]. In a study of 20 subjects having thyroid condition, yoga was found effective in addressing problems such as weight gain, tiredness, hair loss, constipation, weight loss, tremor, laziness and improper hormone level [13]. The yogic practices brought changes in the thyroid disordered patients. One can see the variation in the Triiodothyronine (T3), Tetraiodothyronine (T4) and Thyroid Stimulating Hormone (TSH) after yoga practice [13]. The module used in this study includes practices 26 asanas, four pranayama’s, one kriya, one banda and two relaxation techniques [13]. A case report found that yoga is beneficial for maintaining thyroid level normal [14]. Another study shows that yoga is precious in serving the hypothyroid sufferers to accomplish their disorder related symptoms.

The yoga module in this study was surya namaskara (dynamic physical posture), shitilikarana (loosening), five asanas, six pranayama’s and meditation [15]. One pilot study on hypothyroidism conducted conclude that six months of practice of yoga can also assist in decreasing the thyroxin requirement in woman patients suffering low with hypothyroidism and may also help in enhancing cholesterol level and serum TSH. The yoga module in this study includes starting prayer, five sukshma vyayama-sithilikarna vyayama, suryanamaskaras, 20 asanas, six pranayama’s, one kriya, one Deep Relaxation Technique (DRT), one special technique Mind Sound Resonance Technique (MSRT), once a week cyclic meditation and closing prayer. There is no mention of validating and assessing the feasibility and reliability of the yoga module in the above studies. There are couple of studies validating the yoga module for various health conditions such as low back pain [16], schizophrenia [17], caregivers of psychosis [18], cancer [19], obesity [20], depression [21] obsessive compulsive disorder [22]. Each of these studies follow distinct methodology for validation of the module. The present module development has considered strengths of these studies while designing the methodology. The strength of the study lies in validation of the module by various Subject Matter Experts (SMEs) such as yoga experts, yoga therapists, endocrinologists, physicians, naturopaths, and Ayurveda doctors. Further these experts belonged to different organisations and institutions. The technical inputs concerning internal and biological activities related to hypothyroidism were discussed with a medical practitioner.

Out of the 53 techniques evaluated, 41 techniques scored either CVR more than 0.5 or Mean of mean, median and mode more than 4. (CVR score less than 0.5 in 11 items and Mean was less than 4 in one item). In total 12 items were excluded from the list. They are Hands stretch breathing, Straight leg raise breathing, jogging, Parscvottanasana, Virabadrasana 1, Gomukasana, Marichasana, Baradvajasana, Shalabasana, Agni mudra, Bhajans and Patriotic songs, and Karma yoga. The pilot study to check acceptance and feasibility of performing the yogic techniques by hypothyroid patients was carried with 35 subjects. Most of them performed all the 41 yogic practices in one and half hour time and they did not complain of any adverse effects.

Future studies could consider asserting the reliability and efficacy of the module by conducting a pre-post intervention study. Not performing other validity, reliability and clinical tests could be considered as a limitation of this study.

The developed IAYT program for treating hypothyroid condition received good face and content validity and hence is valid and feasible. The practice of these techniques once by hypothyroid patients did not have any adverse effects. All subject matter professionals validating the study approved on most of these techniques and practices as appropriate. The present validation brings greater acceptability and better therapy module for hypothyroidism. However, future studies must determine the efficacy of the developed module.