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CompletedNCT06716710Updated Jan 6, 2026

Intervention for Fear of Childbirth in High-Risk Pregnant Women

An interventional study of Art therapy group and Control group in Threatened Premature Birth, Premature Membrane Rupture and Gestational Hypertension, sponsored by Kocaeli University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Kocaeli University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
149
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study summary

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.

Read the detailed description

Aim: The aim of the study is to examine the effect of mandala activity applied to pregnant women hospitalized in the clinic due to high-risk pregnancies on pregnancy stress and fear of birth.

Hypothesis 1 H.0: There is no difference in pregnancy stress scores between high-risk pregnant women who participated in the mandala study applied in addition to medical treatment in the hospital and high-risk pregnant women who did not.

H.1: There is a difference in pregnancy stress scores between high-risk pregnant women who participated in the mandala study applied in addition to medical treatment in the hospital and high-risk pregnant women who did not.

Hypothesis 2 H.0: There is no difference in state scores between high-risk pregnant women who participated in the mandala study applied in addition to medical treatment in the hospital and high-risk pregnant women who did not.

H.1: There is a difference in state scores between high-risk pregnant women who participated in the mandala study applied in addition to medical treatment in the hospital and high-risk pregnant women who did not.

Hypothesis 3 H.0: There is no difference in trait anxiety scores between high-risk pregnant women who participated in the mandala study applied in addition to medical treatment in the hospital and high-risk pregnant women who did not.

H.1.: There is a difference in the trait anxiety scores of high-risk pregnant women who participated in the mandala study applied in addition to medical treatment in the hospital and high-risk pregnant women who did not participate.

Hypothesis 4 H.0.: There is no difference in the childbirth anxiety scores of high-risk pregnant women who participated in the mandala study applied in addition to medical treatment in the hospital and high-risk pregnant women who did not participate.

H.1.: There is a difference in the childbirth anxiety scores of high-risk pregnant women who participated in the mandala study applied in addition to medical treatment in the hospital and high-risk pregnant women who did not participate.

Hypothesis 5. H.0.: There is no difference in the childbirth fear scores of high-risk pregnant women who participated in the mandala study applied in addition to medical treatment in the hospital and high-risk pregnant women who did not participate.

H.1.: There is a difference in the childbirth fear scores of high-risk pregnant women who participated in the mandala study applied in addition to medical treatment in the hospital and high-risk pregnant women who did not participate.

Implementation of the Study The study will be explained to the pregnant women included in the study sample, and informed consent forms and permissions will be obtained from those who voluntarily agree to participate. In the study, an introductory information form, STAI TX1 and STAI TX 2, Pregnancy Stress Scale, and FOBS fear of childbirth scale will be used for pregnant women who are admitted to a public hospital gynecology department in Kocaeli and who meet the research criteria. During the interview, mobile phone numbers will be obtained from the pregnant women for communication purposes, and e-mail addresses will be obtained for participation via online platforms (Zoom, Google Meet, etc.) in order to implement the activities in case they are discharged. The forms required for the follow-up of the pregnant women included in the study and control groups will be presented to the pregnant women in printed form. In addition to the medical treatments they will receive in the clinic for 4 weeks, the pregnant women included in the study group will be given 2 mandala painting activities 3 days a week under the supervision of the researcher. In order to ensure standardization in the pregnant women included in the study group, the same mandala work box (36 colored pencils, file, eraser, pencil sharpener and the same mandala prints for all pregnant women) will be given to each pregnant woman. The selection of mandala patterns will be determined by the researchers. In the second week of the training, the researcher will evaluate using STAI TX1 and STAI TX 2, Pregnancy Stress Scale, FOBS fear of childbirth scale. At the end of the four-week activity, the researcher will repeat STAI FORMTX-1, STAI FORMTX-2, Pregnancy Stress Scale and FOBS fear of childbirth scale to determine the level of pregnancy stress and fear of childbirth in the study and control groups, and the final status of pregnancy stress and fear of childbirth will be evaluated. In the event that the participants are discharged from the clinic, the researcher will implement the activities and evaluate the forms through Online Platforms.

Statistical analysis will be used using IBM SPSS Statistic 29.0 (IBM Corp., Armonk, NY, USA). Compliance with normal distribution will be assessed with Shapiro-Wilk. Descriptive statistical methods will be used in the analysis of sociodemographic data. Categorical data with normal distribution will be assessed with parametric tests (chi square, T test etc.), and those that are not will be assessed with nonparametric tests (Mann-Whitney U Test, Kruskal Wallis etc.). One-Way Analysis of Variance in Repeated Measures will be used in the evaluation of repeated measurements. The significance level will be accepted as p\<0.05.

02

Conditions studied

  • Threatened Premature Birth
  • Premature Membrane Rupture
  • Gestational Hypertension
  • Intrauterine Growth Retardation (IUGR)
  • Placenta Previa
  • Hyperemesis Gravidarum - Severe
  • Multiple Pregnancy

Keywords

  • Art Therapy
  • Fear
  • High-Risk Pregnancy
  • Stress
03

In context

Fetal Membranes, Premature Rupture

100 studies on the registry are indexed under Fetal Membranes, Premature Rupture; 23 are open to participants now.

This study's enrollment of 149 is close to the median of 150 across 59 interventional studies indexed under Fetal Membranes, Premature Rupture.

Browse Fetal Membranes, Premature Rupture studies →

Lead sponsor

Kocaeli University is the lead sponsor of 215 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
149 participants (actual)

Study arms

  • Experimental
    Art therapy group

    In addition to the medical treatments that the pregnant women in the study group will receive in the clinic for 4 weeks, they will be given 2 mandala painting sessions, 3 days a week, under the supervision of the researcher.

    Behavioral: Art therapy group

  • Other
    Control group

    Nothing other than routine procedures will be done to the control group.

    Other: Control group

Interventions

  • BehavioralArt therapy group

    In addition to the medical treatments that the pregnant women in the study group will receive in the clinic for 4 weeks, a mandala coloring session will be held 3 days a week, 2 times a week under the supervision of the researcher. In order to ensure standardization in the pregnant women included in the study group, each pregnant woman will be given the same mandala work box (36 colored coloring pencils, file, eraser, pencil sharpener and the same mandala prints for all pregnant women). The selection of mandala patterns will be determined by the researchers. In the second week of the training, the researcher will evaluate the STAI TX1 and STAI TX 2, Pregnancy Stress Scale, and FOBS fear of birth scale. At the end of the four-week activity, the researcher will evaluate again.

  • OtherControl group

    In addition to the medical treatments that the pregnant women in the control group will receive in the clinic for 4 weeks, no other application will be made. After two weeks, the researcher will evaluate them using the STAI TX1 and STAI TX 2, Pregnancy Stress Scale, and FOBS fear of childbirth scale. At the end of the fourth week, the researcher will evaluate them again.

06

What researchers measure

Primary outcomes

  1. State-Trait Anxiety Inventory (STAI FORM TX)

    It will be used to measure state and trait anxiety.

    Time frame: It will be used at the end of the 2nd week and the end of the 4th week of the study.

  2. Pregnancy Stress Scale

    It will be used to measure the stress of the pregnant woman

    Time frame: It will be used at the end of the 2nd week and the end of the 4th week of the study.

  3. Fear of Birth Scale

    It will be used to measure the fear of childbirth.

    Time frame: It will be used at the end of the 2nd week and the end of the 4th week of the study.

07

Study locations

1 site
  • Kocaeli University
    Kocaeli, 41380, Turkey (Türkiye)
08

References and documents

Publications

  • Rondung E, Ternstrom E, Hildingsson I, Haines HM, Sundin O, Ekdahl J, Karlstrom A, Larsson B, Segeblad B, Baylis R, Rubertsson C. Comparing Internet-Based Cognitive Behavioral Therapy With Standard Care for Women With Fear of Birth: Randomized Controlled Trial. JMIR Ment Health. 2018 Aug 10;5(3):e10420. doi: 10.2196/10420. PubMed 30097422 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2024 to primary completion in Oct 2025, 13 months.

Of 23 interventional studies with no phase under Fetal Membranes, Premature Rupture, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 62. This study's 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2024
First posted
Dec 4, 2024
StartActual
Sep 16, 2024
Primary completionActual
Oct 16, 2025
CompletionActual
Dec 16, 2025
Last update
Jan 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06716710
Lead sponsor
Kocaeli University
Responsible party
Sena Dilek Aksoy (Principal Investigator, Kocaeli University) — Principal investigator
First posted
Dec 4, 2024
Start date
Sep 16, 2024
Primary completion
Oct 16, 2025
Completion
Dec 16, 2025
Last update
Jan 6, 2026

Study contacts

Sena Dilek Aksoy, Ph.D.
principal investigator · Kocaeli University
Sena Ozen
study chair · Kocaeli City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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