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NCT03703219 Clinical Trial

Impact of Mothers Touch Program on Women's Psychological Functioning

Psychological Distress Clinical Trial

Official title:
The Role of Indian Post-partum Care in Women's Psychological Functioning

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03703219
Other study ID # NMP 0143
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2018
Est. completion date September 6, 2018

Study information
Verified date October 2018
Source NMP Medical Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study investigates the effect of the Mothers Touch program on the psychological well-being of new mothers following 5 weeks of child birth. Mothers Touch Program is designed based on traditional Indian post-partum care given by trained carer in the family.

Study was designed as cohort, including a randomised controlled trial.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date September 6, 2018
Est. primary completion date July 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Healthy women giving birth for first time (primiparous)

- Given informed consent

- Accepts traditional home care

Exclusion Criteria:

- Previous history of mental health condition

- History drug or substance abuse

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Mothers Touch Program
Combination of diet, massage, body binding methods along with 40 days of rest following the traditional way of delivering

Locations
Country Name City State
India NMP Medical Reserach Institute Jaipur Rajasthan

Sponsors (3)
Lead Sponsor Collaborator
NMP Medical Research Institute Mothers Touch Foundation, India, Warwick Research Services

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Post Natal Depression Edinburgh Postnatal depression Scale 6 weeks following child birth
Secondary General well being General Physical and psychological well being was assessed using General Health Questionnaire 6 weeks following child birth
Secondary Parent-Infant Relationship Parent-Infant Relationship Global Assessment Scale 6 weeks following child birth
Secondary Maternal Confidence Maternal Self-Confidence Scale 6 weeks following child birth
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