Psychological DistressNCT03703219
Impact of Mothers Touch Program on Women's Psychological Functioning
An observational study of Psychological Distress and Post Partum Depression, run by NMP Medical Research Institute at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress, Post Partum Depression, Mood
- What is being tested?
- Mothers Touch Program
- How many people
- 110 participants
- Where
- 1 siteIndia
- Study dates
- 12 Apr 2018to 6 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants giving birth in pre selected 4 hospitals in India.
Who may be able to join
- Healthy women giving birth for first time (primiparous)
- Given informed consent
- Accepts traditional home care
Who cannot join
- Previous history of mental health condition
- History drug or substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Psychological Distress, Post Partum Depression, Mood
- Being tested
- Mothers Touch Program
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mothers Touch ProgramOther
Combination of diet, massage, body binding methods along with 40 days of rest following the traditional way of delivering
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mothers Touch Program | |
| Usual care Program | comparison cohort were followed in usual care under the supervision of health professionals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Natal Depression
Edinburgh Postnatal depression Scale
Measured: 6 weeks following child birth
Secondary outcomes (3)
General well being
General Physical and psychological well being was assessed using General Health Questionnaire
Measured: 6 weeks following child birth
Parent-Infant Relationship
Parent-Infant Relationship Global Assessment Scale
Measured: 6 weeks following child birth
Maternal Confidence
Maternal Self-Confidence Scale
Measured: 6 weeks following child birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start12 Apr 2018
- Primary completion15 Jul 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services, Mothers Touch Foundation, India
- Responsible party
- Sponsor
- Investigators
- Rekha Chaudhari, Study chair, Mothers Touch Foundation, IndiaNeha Sharma, Principal investigator, Warwick Research ServicesSangram Birje, Study director, Mothers Touch Foundation, IndiaAparna Chaudhari, Study director, Mothers Touch Foundation, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703219
- Sponsor's protocol ID
- NMP 0143
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Indian Post-partum Care in Women's Psychological Functioning
- ClinicalTrials.gov ID
- NCT03703219
- Acronym / sponsor ID
- NMP 0143
- Conditions
- Psychological Distress, Post Partum Depression, Mood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services, Mothers Touch Foundation, India
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mother Touch Program | – | Other: Mothers Touch ProgramForty days of rest period of the mother after delivery, Full body massage, diet and belly binding methods were administered by trained carer. |
| Usual care Program | – | –comparison cohort were followed in usual care under the supervision of health professionals. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants giving birth in pre selected 4 hospitals in India.
Key inclusion criteria (3 listed)
- Healthy women giving birth for first time (primiparous)
- Given informed consent
- Accepts traditional home care
Key exclusion criteria (2 listed)
- Previous history of mental health condition
- History drug or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mothers Touch ProgramCombination of diet, massage, body binding methods along with 40 days of rest following the traditional way of delivering | Other | Mother Touch Program |
Primary outcome
Post Natal Depression
Time frame: 6 weeks following child birth
Edinburgh Postnatal depression Scale
3 secondary outcomes
General well being
Time frame: 6 weeks following child birth
Parent-Infant Relationship
Time frame: 6 weeks following child birth
Maternal Confidence
Time frame: 6 weeks following child birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rekha Chaudhari study chair
Mothers Touch Foundation, India
Neha Sharma principal investigator
Warwick Research Services
Sangram Birje study director
Mothers Touch Foundation, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychological Distress and Post Partum Depression, run by NMP Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Natal Depression (time frame: 6 weeks following child birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.