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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
351

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • Artuklu
      • Mardin, Artuklu, Turkey, 47100
        • Mardin Training and Research Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: vaginal birth
Behavioral: skin contact
Ensuring mother-infant skin-to-skin contact by the researcher within the first 5 minutes after birth
Experimental: Childbirth with spinal and epidural anesthesia
Behavioral: skin contact
Ensuring mother-infant skin-to-skin contact by the researcher within the first 5 minutes after birth
No Intervention: Cesarean section under general anesthesia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
9 month
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
nine mounth
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
nine mounth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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