Pregnant Womensmadem EducatiNCT06799689
The Effect of Esmadem Education Model on Spiritual Coping, Tolerance and Depression of High-Risk Pregnant Women
A study testing esmadem education in people with Pregnant Women, run by Burdur Mehmet Akif Ersoy University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnant Women
- What is being tested?
- esmadem education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnant Women
- Being tested
- esmadem education
- Keywords
- pregnant women, spiritual, prenatal attachment, doğum korkusuna
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esmadem educationBehavioural
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,
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| ESMADEM EDUCATİON | Active comparator | Not described Receives: Behavioral: esmadem education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Religious Coping Scale
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.
Measured: baseline and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mine Gokduman Keles, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799689
- Sponsor's protocol ID
- 08.01.2025/01/21decision no
- Acronym
- smadem Educati
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF ESMADEM EDUCATION MODEL ON RELIGIOUS COPING, TOLERANCE AND DEPRESSION OF RISKY PREGNANTS
- ClinicalTrials.gov ID
- NCT06799689
- Acronym / sponsor ID
- smadem Educati / 08.01.2025/01/21decision no
- Conditions
- Pregnant Women
- Keywords
- pregnant women, spiritual, prenatal attachment, doğum korkusuna
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| ESMADEM EDUCATİON | Active comparator | Behavioral: esmadem education |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Able to speak, understand and write Turkish,
- Ages 18-35,
- Having a spontaneous pregnancy,
Key exclusion criteria (3 listed)
- Pregnant women who had fear of childbirth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esmadem educationBy 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, | Behavioural | ESMADEM EDUCATİON |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing esmadem education in people with Pregnant Women, run by Burdur Mehmet Akif Ersoy University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MİNE GÖKDUMAN, 248 213 82 50 (248 213 82 50, minegokdumankeles@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Religious Coping Scale (time frame: baseline and 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.