NCT06799689

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 15, 2025

Last Update Submit

January 28, 2025

Conditions

Keywords

pregnant womenspiritualprenatal attachmentdoğum korkusuna

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline and 3 months.

Study Arms (2)

Control Group

NO INTERVENTION

ESMADEM EDUCATİON

ACTIVE COMPARATOR
Behavioral: esmadem education

Interventions

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,

ESMADEM EDUCATİON

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

MİNE GÖKDUMAN, 248 213 82 50

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD midwife

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 29, 2025

Study Start

February 1, 2025

Primary Completion

June 30, 2025

Study Completion

July 30, 2025

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share