- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06070168
Determining the Effect of Telephone Counseling Service Provided to Primiparous Mothers on Postpartum Depression
The aim of this study is to determine the effect of telephone counseling services provided to primiparous mothers on postpartum depression.
Hypotheses H01; there is no difference between the postpartum depression score of the telephone counseling services group and the postpartum depression score of the control group.
The study will be carried out in two different groups. The practice will start with meeting the women who give birth will be visited by the researcher at the postpartum clinic at least 6 hours after normal birth and 12 hours after cesarean births.
After the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.
The researcher will contact the experimental group by phone. He will introduce herself and 6 weeks (during postpartum). It will provide the mother with the consultancy service she needs about herself and the newborn 24 hours a day. After 6 weeks, the training will end and the third researcher will make post-tests of the depression scale to both groups without knowing the experimental and control groups.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Samsun, Turkey, 55200
- Ondokuz Mayis University
-
-
Atakum
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Samsun, Atakum, Turkey, 55200
- Ondokuz Mayis University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- primiparous women
- Agreeing to participate in the research and obtaining written permission,
- No hearing or vision problems
Exclusion Criteria:
- multiparous women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
|
|
|
Experimental: Telephone Counseling
Mothers in labor after normal birth at the postpartum clinic At least 6 hours later and for cesarean births, the researcher will visit the patient after 12 hours. Mothers will be interviewed according to the inclusion criteria and exclusion criteria, and will be informed about the study. will be given and their consent will be taken, the mother information form and the depression form will be filled in, a pre-test will be done and the communication will be completed will get their numbers. The researcher will contact the experimental group by phone. He will introduce himself and 6 weeks (during postpartum). It will provide the mother with the consultancy service she needs about herself and the newborn 24 hours a day. After 6 weeks, the training will end and the third researcher will make post-tests of the depression scale to both groups without knowing the experimental and control groups. |
Mothers in labor after normal birth at the postpartum clinic At least 6 hours later and for cesarean births, the researcher will visit the patient after 12 hours. Mothers will be interviewed according to the inclusion criteria and exclusion criteria, and will be informed about the study. will be given and their consent will be taken, the mother information form and the Edinburgh Postpartum Depression Scale (EPDS) form will be filled in, a pre-test will be done and the communication will be completed. will get their numbers. The researcher will contact the experimental group by phone. He will introduce himself and 6 weeks (during postpartum) It will provide the mother with the consultancy service she needs about herself and the newborn 24 hours a day. After 6 weeks, the training will end and the third researcher will make post-tests of the depression scale to both groups without knowing the experimental and control groups.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in postpartum depression
Time Frame: immediately postpartum 6 hours later and immediately after the postpartum 6 weeks later
|
Edinburgh Postpartum depression scale Depression Scale
|
immediately postpartum 6 hours later and immediately after the postpartum 6 weeks later
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/485
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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