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

Sponsor

Ondokuz Mayıs University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06070168

Collaborator

(none)

110

Enrollment

Location

Arms

4.9

Anticipated Duration (Months)

22.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression, Postpartum	Other: Telephone Counseling	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 7, 2023

Anticipated Primary Completion Date :

Mar 3, 2024

Anticipated Study Completion Date :

Mar 3, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: 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 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: control group
No Intervention: control group

Arm

Intervention/Treatment

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.

Other: 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 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:

control group

No Intervention: control group

Outcome Measures

Primary Outcome Measures

Change in postpartum depression [immediately postpartum 6 hours later and immediately after the postpartum 6 weeks later]
Edinburgh Postpartum depression scale Depression Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

multiparous women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ondokuz Mayis University	Samsun	Atakum	Turkey	55200

Sponsors and Collaborators

Ondokuz Mayıs University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sümeyye BAL, Ph.D., Ondokuz Mayıs University

ClinicalTrials.gov Identifier:

NCT06070168

Other Study ID Numbers:

2021/485

First Posted:

Oct 6, 2023

Last Update Posted:

Oct 10, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression, Postpartum

Depression

Depressive Disorder

Study Results

No Results Posted as of Oct 10, 2023