NCT06070168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

October 7, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2024

Completed
Last Updated

April 3, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

September 30, 2023

Last Update Submit

April 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in postpartum depression

    Edinburgh Postpartum depression scale Depression Scale

    immediately postpartum 6 hours later and immediately after the postpartum 6 weeks later

Study Arms (2)

Telephone Counseling

EXPERIMENTAL

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.

Other: Telephone Counseling

control group

NO INTERVENTION

Interventions

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.

Also known as: control group
Telephone Counseling

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • primiparous women
  • Agreeing to participate in the research and obtaining written permission,
  • No hearing or vision problems

You may not qualify if:

  • multiparous women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ondokuz Mayis University

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

Ondokuz Mayis University

Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

September 30, 2023

First Posted

October 6, 2023

Study Start

October 7, 2023

Primary Completion

March 3, 2024

Study Completion

March 3, 2024

Last Updated

April 3, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations