NCT07132372

Brief Summary

This study was conducted to examine role of birth memories and recall in relationship between maternal functioning and maternity blues in postpartum women.A cross-sectional design was employed. The study sample consisted of 418 participants from this population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
418

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

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

October 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
Last Updated

August 20, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

July 25, 2025

Last Update Submit

August 19, 2025

Conditions

Keywords

Maternal functionmaternity bluesbirth memory

Outcome Measures

Primary Outcomes (3)

  • The Barkin Index of Maternal Functioning

    The study was completed with 418 participants. Their written and verbal consent was obtained. The Barkin Index of Maternal Functioning: The scale consists of 16 seven-point Likert items.The lowest score from the scale is 0, and the highest is 96. The higher the score is, the higher the functioning is.

    3 months

  • The Postpartum Maternity Blues Assessment Scale

    The Postpartum Maternity Blues Assessment Scale: It has 23 five-point Likert items. The total scores range from 23 to 115. A high score indicates that symptoms of maternity blues are high in the postpartum period.

    3 months

  • The Birth Memories and Recall Questionnaire

    The Birth Memories and Recall Questionnaire: The scale consists of a total of 21 items and 6 sub-dimensions. The mean score of the items on each sub-dimension gives the sub-dimension score. Items 1, 3, and 11 are reverse-scored. The total scores range from 27 to 189. The higher the score is, the higher the memories is. The sub-dimensions are emotional memory, ambivalent emotional memory, centrality of memory, coherence and reliving, sensory memory, and involuntary recall.

    3 months

Study Arms (1)

Data were collected using a personal information form, BIMF, PMBAS, and BirthMARQ.

Data were collected using a personal information form, BIMF, PMBAS, and BirthMARQ.

Other: Birth Memories and Recall scale

Interventions

The data collection tools were applied to the participants by the researcher through face-to-face interviews. At the outset, the purpose of the study was explained to the participants. It was stated that participation in the study was completely voluntary and that they could withdraw from the study at any time. Then, their written and verbal consent was obtained.Participants who agreed to participate in the study, had no condition that would prevent communication, and had babies between the ages of 0 and 1 were included in the study.Data were collected using a personal information form, BIMF, PMBAS, and BirthMARQ.

Data were collected using a personal information form, BIMF, PMBAS, and BirthMARQ.

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The population of the study consisted of mothers who presented to the pediatrics outpatient clinic of the hospital between May 30 and August 30, 2024 and had babies between the ages of 0 and 1. The G\*Power software was used to calculate the sample size. Previous studies were examined (Oruç \& Kukulu, 2022; Kılıç Doğan \& Cesur, 2023) and the expected confidence intervals of the Barkin Index of Maternal Functioning were determined. Accordingly, the sample size was calculated as 90 participants, based on a confidence interval of α = 0.05, a test power (1-β) of 0.95, and an effect size of dz = 0.306. Eventually, the study was completed with 418 participants.

You may qualify if:

  • Mothers with babies aged 0-1 who volunteered to participate in the study who had no conditions that would prevent communication.

You may not qualify if:

  • Mothers with babies over 1 year old who do not wish to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Turkey (Türkiye)

Location

Related Links

Study Officials

  • Ece Kaplan doğan, Dr.

    University of Gaziantep

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant Professor Obstetrics and Gynecology Nursing

Study Record Dates

First Submitted

July 25, 2025

First Posted

August 20, 2025

Study Start

October 15, 2024

Primary Completion

March 15, 2025

Study Completion

June 1, 2025

Last Updated

August 20, 2025

Record last verified: 2025-06

Locations