NCT05723887

Brief Summary

This randomized controlled study was conducted in the pregnant outpatient clinics of a public hospital in Turkey. The sample of the study consisted of a total of 154 pregnant women (77 experiments, 77 controls). An attachment-based intervention program (ABIP) was applied to pregnant women in the experimental group. The ABIP included five interventions; (1) Perceiving/counting fetal movements, (2) Music therapy, (3) Preparation for the baby, (4) Writing notes/letters to the baby, and (5) Watching images of the fetus/pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

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, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

January 13, 2023

Last Update Submit

March 5, 2024

Conditions

Attachment Disorder

Keywords

prenatal distresspregnancyMidw,ifery

Outcome Measures

Primary Outcomes (1)

  • Maternal Antenatal Attachment

    It has a total of 19 items, focusing on pregnant women's feelings, attitudes and behaviors towards the fetus. This is a 5-point Likert type scale, scoring between 1 (the absence of feelings toward the fetus) and 5 (strong emotions toward the fetus).

    one week

Secondary Outcomes (1)

  • Prenatal Maternal Expectations

    one week

Other Outcomes (1)

  • Revised Prenatal Distress Questionnaire

    one week

Study Arms (2)

Experimental (ABIP group)

EXPERIMENTAL

The ABIP was created by the researchers in line with the literature and consisted of interventions that affect and increase prenatal attachment Gölbaşı et al., 2015; Güney \& including perceiving /counting fetal movements, music therapy, preparation for the baby, writing notes/letters to the baby, watching images of the fetus/pregnancy. The program was completed in a total of five days, with one intervention per day. An ABIP kit, which contained the materials to be used by pregnant women during ABIP interventions, was provided to them by the researchers at the first meeting. ABIP intervention materials were included in the ABIP kit, using five different colored envelopes (Appendix 1). Pregnant women were also informed about the interventions and materials of ABIP by the researchers at the first meeting.

Behavioral: Attachment-Based Intervention Program

control groups

NO INTERVENTION

No Intervention: Control group standard care group

Interventions

Attachment-Based Intervention ProgramBEHAVIORAL

Attachment-Based Intervention Program

Experimental (ABIP group)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Over the age of 18, and maimum age 40
  • Pregnancy week between 24-40 weeks

You may not qualify if:

  • Pregnant women with psychological diagnosis according to records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Sabanci Baransel

Malatya, Turkey (Türkiye)

Location

Related Publications (3)

  • Golbasi Z, Ucar T, Tugut N. Validity and reliability of the Turkish version of the Maternal Antenatal Attachment Scale. Jpn J Nurs Sci. 2015 Apr;12(2):154-61. doi: 10.1111/jjns.12052. Epub 2014 Jun 24.

    PMID: 24962076RESULT

  • Pisoni C, Garofoli F, Tzialla C, Orcesi S, Spinillo A, Politi P, Balottin U, Tinelli C, Stronati M. Complexity of parental prenatal attachment during pregnancy at risk for preterm delivery. J Matern Fetal Neonatal Med. 2016 Mar;29(5):771-6. doi: 10.3109/14767058.2015.1017813. Epub 2015 Mar 9.

    PMID: 25747945RESULT

  • Yuksel F, Akin S, Durna Z. Prenatal distress in Turkish pregnant women and factors associated with maternal prenatal distress. J Clin Nurs. 2014 Jan;23(1-2):54-64. doi: 10.1111/j.1365-2702.2012.04283.x. Epub 2013 Jan 11.

    PMID: 23305376RESULT

Study Officials

  • Esra sabancı Baransel, asst. prof.

    esraa.sabancii@gmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 13, 2023

Study Start

August 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

individual participant data were not shared

Locations

TU(1)