The Effect of Training and Counseling Based on Mercer Maternal Role Theory on Maternal Attachment and Maternal Function

August 20, 2024 updated by: Hafize Dağ Tüzmen, KTO Karatay University

The Effect of Training and Counseling Based on Mercer's Maternal Role Theory on Maternal Attachment and Maternal Function: A Randomized Controlled Study

Motherhood role gain is the composition of social roles and developmental behaviors and attitudes that continue with the formation of motherhood identity development in the postnatal period that started during pregnancy. In many studies, it is stated that mothers should be prepared to transition to motherhood roles in the prenatal period in order to enable them to develop successful motherhood identity. This study will be carried out to determine the effect of structured birth preparation education on the material attachment status and motherhood function according to the theory of motherhood. The study was planned as a single -blind, post -test parallel group randomized controlled experimental study. The universe of the study will form pregnant women who apply to Necmettin Erbakan University Meram Medical Faculty Hospital Birth and Gynecology Polyclinic and Clinic. When the sample of the study was calculated as 95 %confidence interval, 5 %error and 80 %power, a total of 44 cases, 22 for the experimental group and 22 for the control group were found to be suitable for statistical analyzes. In this study, assuming that the loss rates in the literature will be 20 %loss when reference, 28 to the experimental group and 28 to the control group will be included in the initially 56 pregnant studies. The data will be collected using the 'Personal Information Form, Postpartum Period Features Information Form, Maternal Binding Scale and Barkin Maternity Function Inventory. Pregnant women in the experimental group will start in the 32nd gestational week and will be given structured training and counseling according to the theory of motherhood. Pregnant women in the control group will take standard care. Number, percentage, average and standard deviation analysis will be used for descriptive statistics. Parametric and nonparametric tests will be applied according to the compliance of the data for the normal distribution of the data in the study pattern in independent groups and recurrent tests. The results will be tested at P <0.05 significance level. In order to collect the data, Ethical Permission was obtained by the Decision No. 2022/024 from the Ethics Committee of KTO Karatay University Pharmaceutical and Medical Research. Necmettin Erbakan University Meram Medical Faculty Hospital will be obtained from the institution. Before starting to work, verbal and written permissions will be obtained by reading the voluntary information form to all pregnant women. Maternal attachment inventory and Barkin Motherhood Function Scale Writers were permitted via e-mail.

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.

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.
56

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Konya, Turkey, 42000
        • KTO Karatay University

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • At least primary school graduate,
  • Between the ages of 18-35,
  • At the 30nd week of pregnancy and above,
  • Having a single and healthy fetus,
  • Pregnant women who are open to communication and cooperation

Exclusion Criteria:

  • Having a risky pregnancy history (pregnancies under 18 and over 35 years of age, EDT, PROM, Preeclampsia, Eclampsia, Epilepsy, GDM)
  • Having a treatment pregnancy (mothers who became pregnant with ART),
  • Having a chronic disease (DM, HT, Asthma, Epilepsy, Autoimmune diseases, self-report),
  • Having a psychiatric illness (based on self-report and clinical diagnosis),
  • Foreign nationals,
  • Living outside the province of Konya,
  • Pregnant women who participated in any childbirth preparation training program

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: Experimental Group
At the beginning of the study, the pregnant women who applied to the obstetrics clinics and met the sample selection criteria will be divided into the experimental and control groups by randomization method by filling out the Personal Information Form. Motherhood Theory-Based Education Program will be applied to the pregnant women who are allocated to the experimental group.
Behavioral: education and counseling based on maternal role theory
Pregnant women in the experimental group will be given training and counseling based on the maternal role theory, starting at 32 weeks of gestation (1 week in total, 2 days a week, 3 sessions every day, 6 sessions in total, 8 hours in total). After the training and counseling program given to the pregnant women in the experimental group according to the motherhood role theory is completed, a training booklet will be prepared so that they can repeat the information they have learned until birth (for improving the motherhood role). It is planned to give the training booklet at the end of the training in order to ensure continuity in the program.
No Intervention: Control Group

First stage: Pregnant women in the control group will receive routine care. Second stage: Data Collection Form for the follow-up and Birth Process and Results will be filled within the first 24 hours after the birth.

Third stage: Follow-up will be done by phone within 4 weeks after birth. Maternal Attachment Scale (MBI), Barkin Maternal Function Inventory will be applied.

Fourth stage: At the end of the fourth month postpartum, follow-up counseling will be made by telephone and the Maternal Attachment Scale and the Barkin Maternal Function scale will be filled.

Fifth stage: When the study is completed, a training booklet will be given to the mothers in the control group.

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 attachment
Time Frame: 1-4 mounth
Maternal attachment will be assessed with the Maternal Attachment Inventory. As the score obtained from the scale increases, attachment increases.
1-4 mounth
Maternal function
Time Frame: 1-4 mounth
Maternal function will be assessed with the Barkin Maternal Functioning Inventory. As the score obtained from the scale increases, attachment increases.attachment scale. As the score obtained from the scale increases, attachment increases.ores of educational practice based on maternal role theory during pregnancy may change.
1-4 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.
KTO Karatay University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KAMİLE ALTUNTUĞ

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.
July 15, 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.
January 12, 2024

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.
August 20, 2024

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).
June 4, 2023

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.
June 15, 2023

First Posted (Actual)

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.
June 18, 2023

Study Record Updates

Last Update Posted (Actual)

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.
August 21, 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.
August 20, 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.
August 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.
  • Mercer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Maternal-Fetal Relations

Clinical Trials on education and counseling based on maternal role theory

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings