NCT06716710Completed
Intervention for Fear of Childbirth in High-Risk Pregnant Women
The Effect of the Clinical Activity Applied to High-Risk Pregnant Women on Pregnancy Stress and Fear of Childbirth
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
The aim of the study is to examine the effects of mandala activity applied to pregnant women hospitalized due to high-risk pregnancies on pregnancy stress and fear of childbirth. The study was designed as an experimental study. The sample size of the study was calculated based on the study conducted by Rondung et al. in 2018 to evaluate the effects of internet-based cognitive behavioral therapy on fear of childbirth. The sample size of the study was calculated using G\*Power 3.1. 9.2 and the mean and standard deviation values of the effect of cognitive behavioral therapy on fear of childbirth variable in the relevant article were taken into account to calculate the effect size. The blended effect size was calculated as 0.28 using the mean and standard deviation of the relevant article. The minimum number of individuals to be included in the sample of this study was calculated with G\*Power 3.1. 9.2 using effect size: 0.28, α= 0.05, power: 0.95 (group1= 75, group2-75) and the sample size was determined to be at least 75 participants in each group. To collect data in the study, Individual Informed Consent Form, Introductory Information Form, STAI FORM TX - 1, STAI FORM TX - 2, Pregnancy Stress Assessment Scale, Fear of Birth Scale will be used.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 149 (actual)
- First submitted
- 29 Nov 2024
- Start date
- 16 Sept 2024
- Primary completion date
- 16 Oct 2025
- Lead sponsor
- Kocaeli University
- Diseases
- High blood pressure
- NCT number
- NCT06716710
What you commit to
- Study type: Interventional
- Participants enrolled: 149
- From 16 Sept 2024 to the primary completion date, 16 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kocaeli University Coordinator of this site? Confirm its status | Kocaeli | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.