Risky PregnanciesNCT06786143
Esmadem Education Model on High-Risk Pregnant Women
A study testing Esmadem Education Model in people with Risky Pregnancies, 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. During pregnancy, sometimes risk situations arise from the mother, sometimes from the fetus. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Risky Pregnancies
- What is being tested?
- Esmadem Education Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women aged 18-45 ,In the second trimester, Primiparous, Have sufficient communication skills, Literate, Can read and understand Turkish, Agree to participate in the research Continuing pregnancy school Having a risky pregnancy diagnosis according to the criteria in the Ministry of Health Pregnancy Risk Assessment Form and having been diagnosed as a risky pregnancy by a physician
Who cannot join
- Having any mental illness
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: The Effect of Esmadem Education Model on Spiritual Coping, Tolerance and Depression of High-Risk Pregnant Women
Pregnancy is a normal and natural process in a woman's life. During this process, anatomical, physiological, biochemical and emotional changes are observed. During pregnancy, sometimes risk situations arise from the mother, sometimes from the fetus. the scope of prenatal care is high today, the main focus is on the physical aspects of care and medical measures. Midwives who provide holistic care should also address spiritual care. Therefore, the esmadem education model will be conducted to examine the effect of the spiritual coping, tolerance and depression of risky pregnancies.
- Conditions
- Risky Pregnancies
- Being tested
- Esmadem Education Model
- Keywords
- risky pregnancies, Education, Spiritual, Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esmadem Education ModelBehavioural
Application Application of the Research The implementation of the research was done in 3 steps.
Step 1: In the first stage of the research, after the risky pregnant women who come to the polyclinic are informed about the study, the participants who agree to participate and meet the criteria for inclusion in the research will be determined by randomization. After the pregnant women assigned to the training or control group sign the voluntary consent form and their consent is obtained, Personal InformationForm, Mishel Uncertainty in Illness Scale Depression-Anxiety-Stress Scale Depression-Anxiety-Stress Scale (DASÖ-21) scales will be applied. After the first interviews, the study group will be informed about the sessions and the training will start via zoom.
In educational sciences, since the number of groups is between 2-20 people in the acquisition of target behaviors at the conceptual level, two training groups will be created and 15 pregnant women will be in the first group, 15 preg
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Not described |
| INTERVENTION 1 | Experimental | Not described Receives: Behavioral: Esmadem Education Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Religious Coping Scale
Measured: aseline and 3 months.
Michel Uncertainty Scale in Illness-Community Form,
Measured: aseline and 3 months.
Depression-Anxiety-Stress Scale
Measured: aseline 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 posted22 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 Risky PregnanciesStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 90 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
- NCT06786143
- Sponsor's protocol ID
- 08.01.2025/01/25decision no
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Esmadem Education Model on Spiritual Coping, Tolerance and Depression of High-Risk Pregnant Women
- ClinicalTrials.gov ID
- NCT06786143
- Acronym / sponsor ID
- 08.01.2025/01/25decision no
- Conditions
- Risky Pregnancies
- Keywords
- risky pregnancies, Education, Spiritual, Depression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 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
- 22 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. During pregnancy, sometimes risk situations arise from the mother, sometimes from the fetus. the scope of prenatal care is high today, the main focus is on the physical aspects of care and medical measures. Midwives who provide holistic care should also address spiritual care. Therefore, the esmadem education model will be conducted to examine the effect of the spiritual coping, tolerance and depression of risky pregnancies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | – |
| INTERVENTION 1 | Experimental | Behavioral: Esmadem Education Model |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women aged 18-45 ,In the second trimester, Primiparous, Have sufficient communication skills, Literate, Can read and understand Turkish, Agree to participate in the research Continuing pregnancy school Having a risky pregnancy diagnosis according to the criteria in the Ministry of Health Pregnancy Risk Assessment Form and having been diagnosed as a risky pregnancy by a physician
Key exclusion criteria (1 listed)
- Having any mental illness
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 Education ModelApplication Application of the Research The implementation of the research was done in 3 steps. Step 1: In the first stage of the research, after the risky pregnant women who come to the polyclinic are informed about the study, the participants who agree to participate and meet the criteria for inclusion in the research will be determined by randomization. After the pregnant women assigned to the training or control group sign the voluntary consent form and their consent is obtained, Personal InformationForm, Mishel Uncertainty in Illness Scale Depression-Anxiety-Stress Scale Depression-Anxiety-Stress Scale (DASÖ-21) scales will be applied. After the first interviews, the study group will be informed about the sessions and the training will start via zoom. In educational sciences, since the number of groups is between 2-20 people in the acquisition of target behaviors at the conceptual level, two training groups will be created and 15 pregnant women will be in the first group, 15 preg | Behavioural | INTERVENTION 1 |
Primary outcome
Religious Coping Scale
Time frame: aseline and 3 months.
Michel Uncertainty Scale in Illness-Community Form,
Time frame: aseline and 3 months.
Depression-Anxiety-Stress Scale
Time frame: aseline and 3 months.
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 22 Jan 2025.
Related trials for Risky Pregnancies
Enrolling by invitationObservational study
Alcohol and Cannabis Use Among Pregnant Slovenian Women
Microbiome Analysis, Drug Abuse in Pregnancy
Not yet recruiting
Synchronous vs. Asynchronous Telerehabilitation for High-Risk Infants
Risky Baby, Premature Birth of Newborn
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 Model in people with Risky Pregnancies, 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 1 inclusion and 1 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 22 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: aseline and 3 months.). The study lists 3 primary outcomes in all. 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 22 Jan 2025.