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Determining the Effect of Telephone Counseling Service Provided to Primiparous Mothers on Postpartum Depression

Primary Purpose

Depression, Postpartum

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telephone Counseling
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression, Postpartum

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: primiparous women Agreeing to participate in the research and obtaining written permission, No hearing or vision problems Exclusion Criteria: multiparous women

Sites / Locations

  • Ondokuz Mayis University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telephone Counseling

control group

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in postpartum depression
Edinburgh Postpartum depression scale Depression Scale

Secondary Outcome Measures

Full Information

First Posted
September 30, 2023
Last Updated
October 7, 2023
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT06070168
Brief Title
Determining the Effect of Telephone Counseling Service Provided to Primiparous Mothers on Postpartum Depression
Official Title
Determining the Effect of Telephone Counseling Service Provided to Primiparous Mothers on Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 7, 2023 (Anticipated)
Primary Completion Date
March 3, 2024 (Anticipated)
Study Completion Date
March 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telephone Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Telephone Counseling
Other Intervention Name(s)
control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in postpartum depression
Description
Edinburgh Postpartum depression scale Depression Scale
Time Frame
immediately postpartum 6 hours later and immediately after the postpartum 6 weeks later

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: primiparous women Agreeing to participate in the research and obtaining written permission, No hearing or vision problems Exclusion Criteria: multiparous women
Facility Information:
Facility Name
Ondokuz Mayis University
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55200
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Determining the Effect of Telephone Counseling Service Provided to Primiparous Mothers on Postpartum Depression

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