NCT06421662

Brief Summary

The study aimed to investigate the effect of attachment training given to pregnant women on mother-infant attachment.Primiparous pregnant women between 28.-38. weeks were randomized into two groups. Pregnant women in the study group were given attachment training for 15 days and the effect of the training on mother-infant attachment was investigated by using the mother-infant attachment scale at postpartum week 8 in comparison with the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

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

August 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 14, 2024

Last Update Submit

May 20, 2024

Conditions

Mother-Infant InteractionInfant DevelopmentMaternal Behavior

Keywords

infantmaternal attachmentattachment training

Outcome Measures

Primary Outcomes (1)

  • Maternal Attachment

    Maternal Attachment Inventory (MAI) Each item contains direct expressions and is always scored as follows: (a)= 4 points, frequently (b)= 3 points, sometimes (c)= 2 points, and never (d)= 1 point. A general score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The total score from the scale ranges from a minimum of 26 to a maximum of 104.

    10 minutes

Study Arms (2)

Study Group

EXPERIMENTAL

Thirty pregnant women between 28th and 38th gestational weeks who applied to the outpatient clinic of a training and research hospital were included in the study group. During the training, 7 participants were excluded due to premature birth.

Behavioral: Attachment Training

Control Group

NO INTERVENTION

Thirty-one pregnant women between 28th and 38th gestational weeks who applied to the outpatient clinic of a training and research hospital were included in the control group. The control group was administered only the "Maternal Attachment Inventory " developed by Mary Muller in 1994 and the Turkish validity and reliability study was conducted by Şirin and Kavlak at the 8th week after birth.

Interventions

Attachment TrainingBEHAVIORAL

The study group was trained online by a psychologist on attachment in two sessions. In order to measure the level of attachment knowledge before and after the training, a test form prepared by the researcher based on the literature and expert opinion was used as pre-test and post-test. In the 8th week after delivery, "Maternal Attachment Inventory " developed by Mary Muller in 1994 and Turkish validity and reliability study was conducted by Şirin and Kavlak.

Study Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrimiparous pregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old with a primiparous pregnancy,
  • to 38 weeks of gestation,
  • At least primary school graduate,
  • Who can use the internet actively and can receive planned training online,
  • Can speak and understand Turkish like a native speaker,
  • Expectant mothers who voluntarily accepted the study.

You may not qualify if:

  • Transferring the pregnant woman to another hospital for follow-up and treatment
  • Those who cannot use active internet and will not be able to receive online education
  • Not completing the post-test after the training
  • Not completing the postpartum maternal attachment scale
  • Expectant mothers receiving psychiatric treatment
  • Those with risky pregnancies
  • Any congenital anomaly in the baby
  • Unwanted baby status
  • Withdrawal of the candidate from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (Türkiye)

Location

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
Assoc.Prof.

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 20, 2024

Study Start

August 1, 2023

Primary Completion

January 1, 2024

Study Completion

March 4, 2024

Last Updated

May 21, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)