A clinical trial to study the effects of slow breathing on heart functions in pregnant women with depressive symptoms.

Not yet recruiting

Conditions: Normal Pregnant females with depressive symptoms (not with diagnosis of Major Depressive Disorder)

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Edinburgh postnatal depression scale.	start and end (8 weeks) of study
Deep Breathing Difference	start and end (8 weeks) of study
Perceived stress scores.	start and end (8 weeks) of study
Low-frequency to high frequency (LF-HF)	start and end (8 weeks) of study
BRS	start and end (8 weeks) of study
Heart rate and Blood Pressure Response to Standing	start and end (8 weeks) of study
Blood Pressure Response to Isometric Hand-grip	start and end (8 weeks) of study

Secondary Outcome Measures

Name	Time	Method
Nor-epinephrine	hs-CRP

Locations (1): JIPMER
🇮🇳
Pondicherry, PONDICHERRY, India
JIPMER
🇮🇳Pondicherry, PONDICHERRY, India
Dr Shah Zinkal Atul
Principal investigator
8524856953
zziina90@gmail.com