NCT06293274

Brief Summary

The study will be conducted with participants who will give birth at Farabi Training and Research Hospital in Darıca District, Kocaeli Province. The sample size of the study was calculated using the G\*Power 3.1.9.2 program, and the effect size of the Edinburgh Postnatal Depression Scale (EPDS) score in the Sun et al. (2021) study was considered in the effect size calculation. In the relevant article, the effect size is reported as effect size: 0.47. In our planned research, the minimum number of individuals to be sampled was calculated using G\*Power 3.1.9.2 with effect size: 0.47 α= 0.05, power: 0.80, and the sample size was set at a minimum of 57 participants in each group. In anticipation of possible data loss, the study will be completed with a total of 140 participants, including 70 cases and 70 routine discharge training groups. This research aims to determine the effect of discharge training on maternal blues and postpartum depression on the levels of maternal blues and postpartum depression during postpartum follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

February 27, 2024

Last Update Submit

June 19, 2024

Conditions

Keywords

dischargematernitysadnessdepression

Outcome Measures

Primary Outcomes (2)

  • Motherhood Sadness Scale

    The scale developed to evaluate motherhood blues consists of 32 items and 8 sub-dimensions. These sub-dimensions; skin-to-skin contact, communication, staying in the same room, breastfeeding, physical adaptation, responsibility, culture, economic factors, information and economic support, social support. Scale items contain positive and negative expressions. The scale is graded as 'completely appropriate (5 points), appropriate (4 points), rarely appropriate (3 points), not appropriate (2 points), not at all appropriate (1 point). The minimum score that can be obtained from the scale is 32 and the maximum score is 160. A high total score in the evaluation of the scale indicates experiencing motherhood blues.

    5-7 days of the postpartum period after the mother's discharge. It will be obtained by the researcher by telephone on the following days.

  • Edinburgh Postnatal Depression Scale - EPDS

    The scale consists of 10 items. Items are evaluated in a 4-point Likert format and scored between 0-3. The lowest score that can be obtained from the scale is 0 and the highest score is 30. Although the cut-off scores for the scale vary between studies, it is stated that a cut-off score of 12 may be sufficient to determine clinical depression. The scale is a screening scale to determine the risk of postpartum depression.

    At 6 weeks postpartum, the researcher will call and administer the 10-item Edinburg Postpartum Depression Scale.

Study Arms (2)

Discharge education

EXPERIMENTAL

Participants assigned to the discharge education group will receive discharge education about postpartum blues and postpartum depression. A "Personal Information Form" will be used. Discharge training and data collection are expected to take approximately 15-20 minutes. 5-7 days postpartum after the mothers are discharged. The 32-item "Motherhood Sadness Scale" will be administered by the researcher by telephone during the following days. In the 6th week of the postpartum period, the mothers will be contacted by the researcher by telephone and the 10-item "Edinburgh Postpartum Depression Scale" will be administered.

Procedure: Discharge training

Routine discharge training

NO INTERVENTION

Participants assigned to the routine discharge training group will receive routine discharge training. "A personal information form will be used. Discharge training and data collection are expected to take approximately 15-20 minutes. 5-7 days postpartum after mothers are discharged. The 32-item "Motherhood Sadness Scale" will be administered by the researcher by telephone during the following days. In the 6th week of the postpartum period, the mothers will be contacted by the researcher by telephone and the 10-item "Edinburgh Postpartum Depression Scale" will be administered.

Interventions

What is motherhood blues? Why does it occur? What are its symptoms? How to deal with it? What is postpartum depression? What causes postpartum depression? Information is provided on this topic.

Also known as: motherhood blues education
Discharge education

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Those who gave birth between weeks of gestation,
  • Those who have had vaginal birth or caesarean section,
  • Able to speak and understand Turkish,
  • Those over 18 years of age,
  • Mothers with a single healthy baby
  • Those with an Edinburgh Postnatal Depression Scale score of 9 or less in depressive symptoms screening

You may not qualify if:

  • Preterm or postterm birth,
  • Received psychiatric treatment or used psychotropic medications during pregnancy,
  • Having a history of substance dependence and/or use in the past 6 months,
  • Being in the high-risk category,
  • Interventional/instrumented birth (Kiwi, vacuum, crystal maneuver),
  • Mothers having babies with congenital malformations requiring intensive care intervention (small for gestational age, mort de fetus, fetus without major pathology according to ultrasonography).
  • Participants who wish to withdraw from the study at any time will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (1)

  • Sun Y, Li Y, Wang J, Chen Q, Bazzano AN, Cao F. Effectiveness of Smartphone-Based Mindfulness Training on Maternal Perinatal Depression: Randomized Controlled Trial. J Med Internet Res. 2021 Jan 27;23(1):e23410. doi: 10.2196/23410.

    PMID: 33502326BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Sena Dilek Aksoy, Ph.D.

    Kocaeli University

    STUDY DIRECTOR

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
Principal Investigator

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 5, 2024

Study Start

January 1, 2024

Primary Completion

April 30, 2024

Study Completion

May 30, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations