NCT05676996

Brief Summary

It is important that effective intervention programs are developed and implemented in our country by identifying risk factors in the early period. In this aspect, the work is unique. Unlike the studies in the literature, it is a unique study in terms of determining the risky population that needs to be questioned and strengthened during the prenatal attachment of expectant mothers during pregnancy, and creating a program where mothers can receive uninterrupted support for 24 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration 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

June 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 30, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

December 30, 2022

Last Update Submit

November 27, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Prenatal attachment of pregnant women who participated in the attachment-based support program in the perinatal period compared to those who did not participate is higher.

    prenatal attachment scale; There are a total of 19 items in the scale, which focuses on the pregnant woman's feelings, attitudes and behaviors towards the fetus. The scale is in a 5-point Likert type and each item is scored between 1 and 5 (5=represents very strong feelings towards the fetus; 1=represents the absence of feelings towards the fetus). A high score from the scale indicates a high degree of attachment.

    22.-26. pre-test between weeks

  • Pregnant women who participated in the Attachment-Based Support Program during the perinatal period showed more early mother-infant attachment symptoms than those who did not.

    The scale of early mother-infant attachment indicators is an observational scale consisting of 13 items. The lowest 0 and the highest 26 points are taken from the scale. As the scores obtained from the scale increase, attachment increases.

    this scale will be administered to mothers on postpartum day 0.

  • Pregnant women who participated in Attachment-Based Support Program in the perinatal period had higher maternal attachment than those who did not.

    The maternal attachment scale is a scale applied at the earliest postpartum 1st month. The lowest score to be obtained from the scale varies between 26 and the highest score between 104. A high score from the scale indicates a high level of maternal attachment.

    postpartum 1st month

  • Prenatal attachment of pregnant women who participated in the attachment-based support program in the perinatal period compared to those who did not participate is higher.

    prenatal attachment scale; There are a total of 19 items in the scale, which focuses on the pregnant woman's feelings, attitudes and behaviors towards the fetus. The scale is in a 5-point Likert type and each item is scored between 1 and 5 (5=represents very strong feelings towards the fetus; 1=represents the absence of feelings towards the fetus). A high score from the scale indicates a high degree of attachment.

    post-test at 36 weeks

Study Arms (2)

attachment-based support group

EXPERIMENTAL

In addition to the routine follow-ups and trainings that the pregnant women in the intervention group can receive from the hospital, they will be included in the "Attachment Based Support Program". Within the scope of the 1st stage of this support; A mobile application. There are 12 videos on connecting in the mobile application. These videos were shot by the researcher in a professional studio. 22nd-26th of pregnancy. The participants included in the study during the weeks of participation installed this mobile application on their phones during participation. It was requested to complete watching the videos by 36 weeks. In the second phase of Attachment-Based Support, breastfeeding and skin-to-skin contact support are provided to mothers on postpartum day 0.

Other: attachment-based support

routine follow-up control group

NO INTERVENTION

The control group pregnants were left to the routine follow-up of the hospitals during their pregnancy and postpartum period. In this follow-up; When pregnant women apply to the outpatient clinic services of the hospital, appointments are made for their monthly routine follow-up. Information and practices that support mother-infant attachment in attachment-based support modules are not included in these trainings.

Interventions

attachment-based support application; It includes video-based trainings on attachment via mobile application and breastfeeding and skin-to-skin contact support for mothers on postpartum day 0.

attachment-based support group

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be 19 years or older 21 and 26. Primigravida at gestational week Having had a normal delivery Watching all the videos within the scope of Attachment-Based Support Program by the pregnant women in the intervention group Being literate Pregnancy with only one baby The baby is at term Being the mother of the primary caregiver Volunteering to participate in the research The absence of any health problems of the mother and the baby Absence of a physician-diagnosed psychiatric disease in the mother Having a smart phone and wireless internet Pregnant women who answered "No" to Question 34 on the Pregnant Introductory Information Form and did not get a full score from the "Maternal Antenatal Attachment Scale"

You may not qualify if:

  • The development of a situation that prevents the mother from participating in education during pregnancy
  • Unwillingness to continue working
  • A situation that prevents the mother and baby from staying in the same room in the postpartum period
  • Severe trauma or loss of the mother during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Training and Research Hospital

Adapazarı, Sakarya, 54050, Turkey (Türkiye)

Location

Study Officials

  • Nursan CİNAR, PhD

    Sakarya University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 30, 2022

First Posted

January 9, 2023

Study Start

June 1, 2021

Primary Completion

November 30, 2022

Study Completion

February 28, 2024

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations