- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06688604
The Effect of Mother-Infant Contact Barrier on Maternal Sadness and Adaptation
November 12, 2024 updated by: Aysel Bulez, Kahramanmaras Sutcu Imam University
The Effect of Infant Attachment Barrier on Maternal Sadness and Adaptation: a Randomized Controlled Trial
This study was conducted to investigate the effect of mother-infant contact deprivation on maternal sadness and maternal adaptation.
The research is a randomized controlled experimental study.
The intervention group consisted of mothers who had vaginal births or cesarean deliveries with epidural/spinal anesthesia (n: 198), while the control group included mothers who had cesarean deliveries under general anesthesia (n: 99).
In the intervention group, mother-infant skin-to-skin contact was ensured within the first 10 minutes after birth.
No intervention was made with the mothers in the control group.
Both groups were assessed within the first 48 hours postpartum using the Mother-Infant Contact Barrier Scale, and on the 14th day postpartum, the Postpartum Self-Evaluation Scale and the Postpartum Maternal Sadness Evaluation Scale were administered to compare the results.
Study Overview
Detailed Description
This study was conducted to investigate the effect of mother-infant contact deprivation on maternal sadness and maternal adaptation.
The research is a randomized controlled experimental study.
The intervention group consisted of mothers who had vaginal births or cesarean deliveries with epidural/spinal anesthesia (n: 198), while the control group included mothers who had cesarean deliveries under general anesthesia (n: 99).
In the intervention group, mother-infant skin-to-skin contact was ensured within the first 10 minutes after birth.
No intervention was made with the mothers in the control group.
Both groups were assessed within the first 48 hours postpartum using the Mother-Infant Contact Barrier Scale, and on the 14th day postpartum, the Postpartum Self-Evaluation Scale and the Postpartum Maternal Sadness Evaluation Scale were administered to compare the results.
Study Type
Interventional
Enrollment (Actual)
351
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
-
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Artuklu
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Mardin, Artuklu, Turkey, 47100
- Mardin Training and Research Hospital
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Had given birth at Mardin Training and Research Hospital
- No physical and/or mental health issues
- No infectious diseases transmitted through contact
- Agreed to participate in the study
- Able to speak Turkish and/or does not have communication issues
- Single live birth with the baby
- Mothers who gave birth vaginally or via spinal anesthesia and had skin-to-skin contact with their baby within the first 5 minutes postpartum
Exclusion Criteria:
Foreign nationals, immigrants, or those with communication issues
- Individuals with any physical and/or mental health problems
- Those with infectious diseases transmitted through contact
- Individuals who did not agree to participate in the study
- Mothers whose baby was stillborn (ex) after birth
- Mothers whose babies were receiving treatment in the intensive care unit
- Those who do not wish to provide a phone number
- Women who gave birth vaginally or via spinal anesthesia and do not wish to establish contact with their baby
- Mothers who gave birth to twins or more babies
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: vaginal birth
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Ensuring mother-infant skin-to-skin contact by the researcher within the first 5 minutes after birth
|
|
Experimental: Childbirth with spinal and epidural anesthesia
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Ensuring mother-infant skin-to-skin contact by the researcher within the first 5 minutes after birth
|
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No Intervention: Cesarean section under general anesthesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maternal Sadness and Adaptation
Time Frame: 9 month
|
The development, reliability and validity study of the scale was conducted by Küçük and Cesur (Küçük, E. (2022) Postpartum maternity blues assesment scale: Improvement, validity and reliability study) (Thesis No. 727989) [Master's thesis, Sivas Cumhuriyet University] National Thesis Center of the Council of Higher Education.) in 2022.
The scale included questions prepared to determine the psychological changes that occur in the mother in the postpartum period and what kind of problems these changes may create in the mother.
The scale was created as a 5-point Likert type to be answered by the participants.
The scale contains 23 items.
The items in the scale were applied as '1- Strongly disagree, 2-Disagree, 3-Undecided, 4-Agree, 5- Strongly Agree'.
A high score on the scale indicates that the symptoms of maternal sadness in the postpartum period are high.
A scale consisting of three sub-dimensions with 23 items (First Factor 'Maternal self-care dimension', second factor 'Infant care di
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9 month
|
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Postpartum Self-Assessment Scale
Time Frame: nine mounth
|
It was decided to be developed by Lederman and Weingarten in 1981 to evaluate the adaptation process of women in the postpartum period to motherhood.
It is a 4-point Likert-type scale with 82 items.
There are 7 subscales that evaluate the Postpartum Self-Assessment Scale.
Each subscale contains 10 to 13 items.
39 of the items in the scale are reverse-biased.
The numbers of the reverse-biased items in the scale are as follows; 1, 2, 4, 6, 9, 10, 14, 15,16, 22, 29, 30, 32, 33, 36, 38, 40, 41, 42, 43, 44, 46, 47, 49, 51, 53, 54, 59, 61, 62, 67, 69, 71, 73, 77, 78, 79, 81, 82.
The scale is measured with a 4-point assessment.
Postpartum adjustment is evaluated based on the results of scores ranging from "1" to "4" (4: "Describes very much," 3: "Partially describes," 2: "Somewhat describes," 1: Does not describe at all").
Scoring for reverse items is done in the opposite way.
The lowest possible score for the entire scale is 82, and the highest is 328.
Low scores indicate that the adaptatio
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nine mounth
|
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Mother-Infant Contact Barrier Scale
Time Frame: nine mounth
|
Development of the Scale and Examination of Its Psychometric Properties was conducted by Kömürcü Akik and Durak Batıgün (Akik, B. K., & Batıgün, A. D. (2020).
Mother-Infant Contact Barrier Scale (ABTEÖ): Development and Psychometric Properties.
Current Approaches in Psychiatry/Psikiyatride Guncel Yaklasimlar, 12.) in 2020.
It was planned to be developed to measure possible contact barriers that may be experienced between the mother and the baby, such as difficulties in adaptation between the mother and the baby after birth and negative experiences related to birth, based on the mother's report.
A total of 38-item question pool form was created by the authors.
After the preliminary preparations, a 37-item form with Likert-type scores from 1 to 5 ("1 = Doesn't Apply to Me at All", "2 = Doesn't Apply to Me", "3 = Undecided", "4 = Applies to Me Somewhat", and "5 = Applies to Me Completely") was created.
The 37-item version of the scale was applied to the participants.
As a result of the v
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nine mounth
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- Eyquem A, de Saint Martin J. [Clinical significance of circulating autoantibodies]. Ann Immunol (Paris). 1977 Jan-Mar;128(1-2):285-6. French.
- Bystrova K, Ivanova V, Edhborg M, Matthiesen AS, Ransjo-Arvidson AB, Mukhamedrakhimov R, Uvnas-Moberg K, Widstrom AM. Early contact versus separation: effects on mother-infant interaction one year later. Birth. 2009 Jun;36(2):97-109. doi: 10.1111/j.1523-536X.2009.00307.x.
- Rowe-Murray HJ, Fisher JR. Operative intervention in delivery is associated with compromised early mother-infant interaction. BJOG. 2001 Oct;108(10):1068-75. doi: 10.1111/j.1471-0528.2001.00242.x.
- Karimi FZ, Sadeghi R, Maleki-Saghooni N, Khadivzadeh T. The effect of mother-infant skin to skin contact on success and duration of first breastfeeding: A systematic review and meta-analysis. Taiwan J Obstet Gynecol. 2019 Jan;58(1):1-9. doi: 10.1016/j.tjog.2018.11.002.
Helpful Links
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)
January 1, 2023
Primary Completion (Actual)
August 16, 2023
Study Completion (Actual)
September 1, 2023
Study Registration Dates
First Submitted
November 6, 2024
First Submitted That Met QC Criteria
November 12, 2024
First Posted (Estimated)
November 14, 2024
Study Record Updates
Last Update Posted (Estimated)
November 14, 2024
Last Update Submitted That Met QC Criteria
November 12, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-2022/14-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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