Intervention for Fear of Childbirth in High-Risk Pregnant Women
Launched by KOCAELI UNIVERSITY · Nov 29, 2024
Trial Information
Current as of November 13, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This study is testing whether adding a mandala art therapy program to usual hospital care can help reduce pregnancy stress and fear of childbirth in women with high-risk pregnancies who are staying in the hospital. It is a randomized trial, so participants are assigned by chance to either receive art therapy plus standard care or standard care alone. About 150 adult women (18–50 years old) in their second or third trimester (roughly 13–40 weeks) with high-risk pregnancy conditions—such as threatened preterm birth, early water breaking, high blood pressure during pregnancy, fetal growth problems, placenta previa, or severe morning sickness—are eligible if it’s their first pregnancy, they can understand Turkish, and they’re willing to participate. Participants must be able to attend the art sessions; those who miss too many sessions or who plan to give birth during the study may be excluded.
If enrolled, the art therapy group will take part in mandala coloring sessions in addition to their usual medical care for about four weeks, while the control group receives only usual care. The study will check levels of anxiety, pregnancy stress, and fear of birth at roughly week 2 and week 4 using standard questionnaires. If a participant leaves the hospital early, follow-up can be done online. The study is being conducted at Kocaeli University in Turkey, and no results are available yet.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Those who want to participate in the study voluntarily
- • Those who can speak and understand Turkish
- • Those who are over 18 years of age
- • Primiparous pregnant women
- • Pregnant women diagnosed with risky pregnancies (threatened preterm labor, premature rupture of membranes, gestational hypertension, intrauterine growth retardation, placenta previa, hyperemesis gravidarum)
- • Pregnant women in the second and third trimesters of pregnancy (13-40 weeks)
- • Those who do not have hearing, comprehension and vision problems so that they can follow the group study will be included in the study.
- Exclusion Criteria:
- • Pregnant women who are absent from the mandala activity planned 3 times a week for 4 weeks for more than a week
- • Those who do less than 18 mandala activities during 4 weeks
- • Those who fill out the survey forms incompletely
- • Pregnant women who decide to give birth during the survey period will be excluded from the study.
About Kocaeli University
Kocaeli University, a prominent institution in Turkey, is dedicated to advancing medical research and education through its comprehensive clinical trial initiatives. With a focus on innovative healthcare solutions, the university collaborates with leading researchers and healthcare professionals to conduct rigorous scientific studies aimed at improving patient outcomes. By fostering an environment of academic excellence and interdisciplinary collaboration, Kocaeli University aims to contribute significantly to the global medical community while ensuring adherence to ethical standards and regulatory guidelines in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kocaeli, Turkey
Patients applied
Trial Officials
Sena Dilek Aksoy, Ph.D.
Principal Investigator
Kocaeli University
Sena Ozen
Study Chair
Kocaeli City Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported