CClinicalTrials.gg
CompletedNCT06070168Updated Apr 3, 2024

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

An interventional study of Telephone Counseling in Depression, Postpartum, sponsored by Ondokuz Mayıs University. Completed at 2 sites in Turkey. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by Ondokuz Mayıs University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

03

In context

Depression, Postpartum

528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.

This study's enrollment of 110 is close to the median of 105 across 425 interventional studies indexed under Depression, Postpartum.

Browse Depression, Postpartum studies →

Lead sponsor

Ondokuz Mayıs University is the lead sponsor of 262 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • multiparous women
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • 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

  • No intervention
    control group

Interventions

  • OtherTelephone 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.

    Also known as: control group

06

What researchers measure

Primary outcomes

  1. Change in postpartum depression

    Edinburgh Postpartum depression scale Depression Scale

    Time frame: immediately postpartum 6 hours later and immediately after the postpartum 6 weeks later

07

Study locations

2 sites
  • Ondokuz Mayis University
    Samsun, Atakum 55200, Turkey
  • Ondokuz Mayis University
    Samsun, 55200, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06070168
Lead sponsor
Ondokuz Mayıs University
Responsible party
Sümeyye BAL (Ph.D., Ondokuz Mayıs University) — Principal investigator
First posted
Oct 6, 2023
Start date
Oct 7, 2023
Primary completion
Mar 3, 2024
Completion
Mar 3, 2024
Last update
Apr 3, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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