Effects of slow pranayamas on cardiac autonomic functions in pregnant women with depressive symptoms â€“ Arandomized control trial.

JIPMER1 个研究点分布在 1 个国家目标入组 140 人开始时间: 2017年8月14日最近更新: 2017年8月8日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: JIPMER
入组人数: 140
试验地点: 1
主要终点: Edinburgh postnatal depression scale.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized parallel group open label trail comparing the effect of slow pranayamas, for 8 weeks in 70 pregnant females with depressive symptoms, compared with 70 controls receiving standard antenatal care, on cardiac autonomic functions to be conducted in JIPMER, Puducherry, India. All the primary and secondary outcomes will be measured at end of 8 weeks in both subjects and controls

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 30.00 Year(s)（—）
性别: Female

入选标准

•Pregnant women of 12-15 weeks of gestation.
•Women with depressive symptoms as defined by (i) Edinburgh Postnatal Depression Scale (EPDS) scores 1- 9; and (ii) those with EPDS scores 9 or more and less than 19, but current clinical depression is ruled out by Psychiatrist by use of Mini International Neuropsychiatric Interview (MINI 6.0).
•Able to read and understand English or Tamil.

排除标准

•Pregnant women diagnosed with major depressive disorder.
•Known case of psychiatric illness including depression needing pharmacological treatment.
•Past history of depression or maniac episode.
•Known cases of diabetes.
•Known renal disease.
•Known cases of hypertension, pre-eclempsia.
•Known cases cardiac disorders.
•Having multiple pregnancies.
•History of previous pregnancy loss due to known single gene defects, chromosomal disorders, intrauterine infections, in vitro fertilization pregnancy, previous history of intra uterine growth retardation.
•Known maternal structural abnormalities like kyphosis/ scoliosis.
•Women on any medications except for nutritional supplements.
•Women undergoing yoga in past one month.