Effect of Mantra Chikitsa on Pregnancy and Newborn Baby

Effect of Mantra (hymn) Therapy During Pregnancy on the Feto-maternal Wellbeing and Attachment-An Open Label Randomized Controlled Trial

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/053135

Enrollment

130

Registered

2023-05-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O28- Abnormal findings on antenatal screening of mother Health Condition 2: O00-O9A- Pregnancy, childbirth and the puerperium

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. All Nulliparous and Multiparous women of 20-32 years of age attending the Prasuti Tantra OPD at 6-8 weeks of Pregnancy with single live intrauterine pregnancy. Gestational age will be based on clinical findings and 1st-trimester USG (obs) scan. 2. Pregnant women without serious co-morbidities or risks associated with pregnancy.

Exclusion criteria

Exclusion criteria: 1. Pregnant women with profound hearing loss. 2. Pregnant women have systemic diseases like Diabetes mellitus(DM), Hypertension (HTN), Tuberculosis (TB), heart diseases, severe anaemia, chronic and acute liver and renal diseases, jaundice, coagulation disorders etc. 3. Pregnant women have a history of a genetic disorder in the family. 4. Multiple pregnancies 5. Psychiatric patient or history of bipolar disorder, depression, anxiety and any other psychological disorders which require medications. 6. Pregnant women have an addiction history to alcohol and drugs. 7. Drug history of prolonged steroid medication.

Design outcomes

Primary

Measure	Time frame
1. Reduction of maternal anxiety during pregnancy. 2. Reduction of post-natal depression 3. Study of Neonatal Neurobehaviour. 4. Study of the effect of Mantra Therapy on feto-maternal attachment during pregnancy and mother or child bonding after delivery. 5. Effect of Mantra Therapy on Uterine Artery Colour Doppler Indices 6. evaluate the effect of Mantra Therapy on Placental gene expression of NR3C1 and HSD11B2 Timepoint: 1. 6-8,10-12, 14-16, 18-20, 22-24, 26-28, 30-32, 34-36, 38-40 weeks of pregnancy 2. During labor 3. 3rd, 7th, 15th, 30th post-partum day	—

Measure

Time frame

1. Reduction of maternal anxiety during pregnancy. 2. Reduction of post-natal depression 3. Study of Neonatal Neurobehaviour. 4. Study of the effect of Mantra Therapy on feto-maternal attachment during pregnancy and mother or child bonding after delivery. 5. Effect of Mantra Therapy on Uterine Artery Colour Doppler Indices 6. evaluate the effect of Mantra Therapy on Placental gene expression of NR3C1 and HSD11B2 Timepoint: 1. 6-8,10-12, 14-16, 18-20, 22-24, 26-28, 30-32, 34-36, 38-40 weeks of pregnancy 2. During labor 3. 3rd, 7th, 15th, 30th post-partum day

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Secondary

Measure	Time frame
1. State-trait Anxiety Inventory (STAI-S) score 2. Maternal-Fetal Attachment Scale 3. Serum Cortisol 4. Uterine Artery Colour Doppler Indices- RI, PI, and S/D ratio 5. Complete Proteomic Profiling and Serum Cortisol 6. VAS (Visual Analogue Scale) 7. Maternal Postnatal Attachment Scale (MPAS) 8. Edinburgh Postnatal Depression Scale (EPDS) 9. Hammersmith short neonatal neurological examination or NICU Network Neurobehavioral Scale (NNNS) 10. Gestational Age at Birth 11. Birth Weight 12. Birth size- Crown heel length, Head circumference, Chest circumference, abdominal circumference and mid-arm circumference. 13. Apgar score 14. Vital Signs (Monitoring) 15. Neonatal blood cortisol 16. Placental gene expression of NR3C1 and HSD11B2 Timepoint: 1. 6-8,10-12, 14-16, 18-20, 22-24, 26-28, 30-32, 34-36, 38-40 weeks of pregnancy 2. During labor 3. 3rd, 7th, 15th, 30th post-partum day	—

Measure

Time frame

1. State-trait Anxiety Inventory (STAI-S) score 2. Maternal-Fetal Attachment Scale 3. Serum Cortisol 4. Uterine Artery Colour Doppler Indices- RI, PI, and S/D ratio 5. Complete Proteomic Profiling and Serum Cortisol 6. VAS (Visual Analogue Scale) 7. Maternal Postnatal Attachment Scale (MPAS) 8. Edinburgh Postnatal Depression Scale (EPDS) 9. Hammersmith short neonatal neurological examination or NICU Network Neurobehavioral Scale (NNNS) 10. Gestational Age at Birth 11. Birth Weight 12. Birth size- Crown heel length, Head circumference, Chest circumference, abdominal circumference and mid-arm circumference. 13. Apgar score 14. Vital Signs (Monitoring) 15. Neonatal blood cortisol 16. Placental gene expression of NR3C1 and HSD11B2 Timepoint: 1. 6-8,10-12, 14-16, 18-20, 22-24, 26-28, 30-32, 34-36, 38-40 weeks of pregnancy 2. During labor 3. 3rd, 7th, 15th, 30th post-partum day

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Countries

India

Contacts

Public ContactPreeti Chouhan

Institute of Medical Sciences, Banaras Hindu University

ssom18@gmail.com9413636378

Outcome results