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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05723887
Other study ID # 2020/605
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date February 1, 2021

Study information

Verified date March 2024
Source Inonu University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This study aimed to determine the effect of attachment-based intervention program on attachment, prenatal expectation and stress level in pregnant women. 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. The program was completed in a total of 5 days, one session per day.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date February 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:Communicating, - Over the age of 18, and maimum age 40 - Pregnancy week between 24-40 weeks Exclusion Criteria: - Pregnant women with psychological diagnosis according to records

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Attachment-Based Intervention Program
Attachment-Based Intervention Program

Locations

Country Name City State
Turkey Esra Sabanci Baransel Malatya

Sponsors (2)

Lead Sponsor Collaborator
Inonu University Tuba Uçar

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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: 10.3109/1 — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Revised Prenatal Distress Questionnaire This is a three-point Likert-type scale, scoring from 0 (never) to 2 (very often). Total scale score ranges between 0 and 34. A higher total score indicates greater prenatal distress perceived by pregnant women. one week
Primary 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 Prenatal Maternal Expectations This is a 5-point Likert type scale, scoring from 1 (strongly agree) to 5 (strongly disagree). It consists of 34 items and two subscales: (1) Unrealistic Positive Prenatal Expectations (21 items measuring the mother's positive expectations about childbirth and motherhood role), (2) Unrealistic Negative Prenatal Expectations (13 items measuring the mother's negative expectations about childbirth and motherhood role). one week
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