Impact of Mothers Touch Program on Women's Psychological Functioning

October 19, 2018 updated by: NMP Medical Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Rajasthan
      • Jaipur, Rajasthan, India
        • NMP Medical Reserach Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Participants giving birth in pre selected 4 hospitals in India.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mother Touch Program
Forty days of rest period of the mother after delivery, Full body massage, diet and belly binding methods were administered by trained carer.
Other: Mothers Touch Program
Combination of diet, massage, body binding methods along with 40 days of rest following the traditional way of delivering
Usual care Program
comparison cohort were followed in usual care under the supervision of health professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Natal Depression
Time Frame: 6 weeks following child birth
Edinburgh Postnatal depression Scale
6 weeks following child birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General well being
Time Frame: 6 weeks following child birth
General Physical and psychological well being was assessed using General Health Questionnaire
6 weeks following child birth
Parent-Infant Relationship
Time Frame: 6 weeks following child birth
Parent-Infant Relationship Global Assessment Scale
6 weeks following child birth
Maternal Confidence
Time Frame: 6 weeks following child birth
Maternal Self-Confidence Scale
6 weeks following child birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMP Medical Research Institute

Collaborators

Warwick Research Services
Mothers Touch Foundation, India

Investigators

  • Study Chair: Rekha Chaudhari, Mothers Touch Foundation, India
  • Principal Investigator: Neha Sharma, Warwick Research Services
  • Study Director: Sangram Birje, Mothers Touch Foundation, India
  • Study Director: Aparna Chaudhari, Mothers Touch Foundation, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2018

Primary Completion (Actual)

July 15, 2018

Study Completion (Actual)

September 6, 2018

Study Registration Dates

First Submitted

October 9, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (Actual)

October 11, 2018

Study Record Updates

Last Update Posted (Actual)

October 22, 2018

Last Update Submitted That Met QC Criteria

October 19, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMP 0143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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