- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05723887
Attachment-Based, Attachment, Prenatal
March 5, 2024 updated by: Esra SABANCI BARANSEL, Inonu University
The Effect of Attachment-Based Intervention Program on Attachment, Prenatal
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
154
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Malatya, Turkey
- Esra Sabanci Baransel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental (ABIP group)
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.
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Attachment-Based Intervention Program
|
|
No Intervention: control groups
No Intervention: Control group standard care group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Antenatal Attachment
Time Frame: one week
|
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).
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one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prenatal Maternal Expectations
Time Frame: one week
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Revised Prenatal Distress Questionnaire
Time Frame: one week
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Esra sabancı Baransel, asst. prof., esraa.sabancii@gmail.com
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
February 1, 2021
Study Completion (Actual)
February 1, 2021
Study Registration Dates
First Submitted
January 13, 2023
First Submitted That Met QC Criteria
February 1, 2023
First Posted (Actual)
February 13, 2023
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2020/605
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
individual participant data were not shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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