The Effect of Esmadem Education Model on Spiritual Coping, Tolerance and Depression of High-Risk Pregnant Women (smadem Educati)

January 28, 2025 updated by: Mine Gokduman Keles, Burdur Mehmet Akif Ersoy University

EFFECT OF ESMADEM EDUCATION MODEL ON RELIGIOUS COPING, TOLERANCE AND DEPRESSION OF RISKY PREGNANTS

Pregnancy is a normal and natural process in a woman's life. During this process, anatomical, physiological, biochemical and emotional changes are observed. The changes are a period in which social, biophysical and psychological changes are experienced, which also means a journey into the unknown for the woman and her family. Although the scope of prenatal care is high today, the main focus is on the physical aspects of care and medical precautions. Midwives who provide holistic care should also address spiritual care. Therefore, the ESMADEM training model will be conducted to examine the effect of the spiritual coping, prenatal attachment and fear of birth of pregnant women.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Pregnancy is a normal and natural process in a woman's life. During this process, anatomical, physiological, biochemical and emotional changes are observed. The changes are a period in which social, biophysical and psychological changes occur, which also mean a journey into the unknown for the woman and her family . It has been reported that supporting pregnant women by midwives during this period and encouraging birth as a positive experience reduces fear of birth and increases prenatal attachment . In facilitating adaptation to the changes experienced and increasing the level of health; Complementary practices and education such as exercise, biofeedback, meditation, and prayer are used . One of these practices is spiritual care. Spirituality involves recognizing one's goals in life and the meaning of life. These conceptualizations are not always associated with religious beliefs. The purpose of spiritual care is to help people seek meaning and purpose in life. Spiritual teachings can have behavioral, cognitive, emotional and ethical aspects and can manifest themselves with trust, patience and prayer . One of these prayers is Esmâ-i Hüsnâ. Esmâ-i Hüsnâ is an expression that expresses all the names that are stated to belong to. Esmadem: It is a spiritual support model that provides significant contributions to spiritual development and life skills, where life skills are acquired and psychological and guidance practices are included, and aims at cognitive, emotional and behavioral gains. In this model, the name Şekur is taken as the center for stress. Along with this center name, the names Hallak, Bâki, Melik, Kahhâr and Muntekim are given for depression; Müheymin and Rakib for anxiety; and Halim, Latif, Rezzak, Rahman, Rahim for stress. Although the scope of prenatal care is high today, it is seen that the main focus is on the physical aspects of care and medical precautions. Midwives who provide holistic care should also take spiritual care into consideration. Therefore, the ESMADEM training model will be conducted to examine the effect of the spiritual coping, prenatal attachment and fear of birth of pregnant women.

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 (Estimated)

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.
96

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.

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

No

Description

Inclusion Criteria:

  • Able to speak, understand and write Turkish,
  • Ages 18-35,

  • Having a spontaneous pregnancy,

    • Volunteering to participate in the study,
    • According to the last menstrual period (LMS) or ultrasonography (USG) records, in the 24th week of pregnancy,
    • No risk factors,
    • Having a phone number to contact for educational meetings,
    • Participating in a pregnancy school

Exclusion Criteria:

  • Pregnant women who had fear of childbirth

    • Chronic and/or psychiatric health problems
    • Failed to attend at least three sessions of the training program Who were at risk during any stage of the study Who could not be interviewed within the first 24 hours after birth were excluded from the study.

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: Double

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.
No Intervention: Control Group
Active Comparator: ESMADEM EDUCATİON
Behavioral: esmadem education
By providing information about Esma-i Husna, the journey of knowing oneself and character building with Esma-i Husna will be emphasized. It will be carried out with the aim of building on 99 names, namely Allah, Rahman and Rahim, and reducing depressive feelings by benefiting from the guidance of these names.In the second session, it will be explained through the names Esma-i Husna, Celal and Cemal in order to manage depressive feelings and contribute to positive coping. The togetherness of pain as well as happiness, ease along with difficulty, joy along with sadness in a balanced life will be discussed with the name "Zü'l Celâl ve'l İkram" and the study of "Journey to perfection through the names Celal and Cemal". The meaning of existence and life in spirit will be discussed through the name Rab, the life cycle will be explained by establishing a relationship with the names Hafıd-Râfi, Kâbıd-Bâsıt, Muız-Müzil. In addition, it will be carried out within the framework of the name Hakim,

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
Religious Coping Scale
Time Frame: baseline and 3 months.
Positive and negative religious coping scores are calculated separately in the scale. A total religious coping score is not obtained. The raw score that can be obtained from the positive religious coping subscale varies between 7 and 28, and the raw score that can be obtained from the negative religious coping subscale varies between 3 and 12.
baseline and 3 months.

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.
Burdur Mehmet Akif Ersoy University

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 (Estimated)

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.
February 1, 2025

Primary Completion (Estimated)

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.
June 30, 2025

Study Completion (Estimated)

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.
July 30, 2025

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).
January 15, 2025

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.
January 28, 2025

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.
March 25, 2025

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.
March 25, 2025

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.
January 28, 2025

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.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • 08.01.2025/01/21decision no

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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.

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