Role of individualized homoeopathic medicine in emotional dysregulation of women with chronic pelvic pain from gynaecological disorders- a single arm pre-post clinical study.

Chronic Pelvic Pain (CPP) is persistent pelvic pain for at least 6 months and is severe enough to cause functional disability and lead to medical care. CPP cannot be viewed as single entity, rather a constellation of predisposing factors and altered mechanism, is an important presenting symptom that can arise from a diverse group of disorders. The incidence of CPP associated with gynaecological disorders are probably in excess. Gynaecological comorbidities are seen in an estimated twenty percent of patients with chronic pelvic pain. Specific gynaecological conditions that can cause CPP include endometriosis, pelvic adhesions, chronic pelvic inflammatory diseases, ovarian remnant, pelvic congestion syndrome and adenomyosis. The prevalence of CPP is approximately between four to sixteen percent of women. Up to 24% of women globally suffer from CPP. Emotion regulation plays a vital role in maintaining psychological well- being and significant implications for both physical and mental health. Research proves that by effectively recognizing, understanding and managing human emotions helps in overall well - being of the individuals extending its benefits to physiological process and normalization of pelvic and hormonal physiology. The study is focused on women with CPP from gynaecological disorders, due to amalgamation of emotions and hormonal changes that is clearly evident in monthly menstrual cycle of women. These disturbances show up as menstrual irregularities, severe premenstrual syndrome, leucorrhea and mood swings. An Individualized homoeopathic medicine based on totality of symptoms which include patient’s mental and physical sphere works holistically improving the mental sphere and improve physical signs and symptoms that are evident in homoeopathic cures. A Prospective, Nonrandomized, Open label, Single arm, Pre- Post Clinical Study with a sample size of 40 female chronic pelvic pain patients from gynaecological disorders satisfying inclusion and exclusion criteria shall be enrolled for the study. CPP patients suffering from gynaecological disorders who score 19 or below in cognitive reappraisal and 7 or above in expressive suppression in Emotion Regulation Questionnaire (ERQ) will be only enrolled for the study. The primary objective is to determine the changes in Difficulty in Emotion regulation Scale (DERS) at the baseline and after 6 months of intervention with Individualized homoeopathic medicine in suitable potency in accordance with the directions in Organon of Medicine (6th edition).  Secondary objective is to determine the changes in intensity of pain in Functional Pelvic Pain Scale (FPPS) at the baseline and after 6 months of intervention. Ultrasound assessment of the abdomen and pelvis would be used as a secondary outcome tool for diagnosing gynaecological  disorders. The descriptive data will be recorded in terms of absolute values, percentage etc. as appropriate. The score obtained by the patients will be compared and result analyzed as per appropriate statistical methods and inference will be done thereafter. The result will be published in scientific journals.