Threatened Premature BirthNCT06716710
Intervention for Fear of Childbirth in High-Risk Pregnant Women
A study testing Art therapy group in people with Threatened Premature Birth and Premature Membrane Rupture, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Threatened Premature Birth, Premature Membrane Rupture, Gestational Hypertension
- What is being tested?
- Art therapy group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2024to 16 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Clinical Activity Applied to High-Risk Pregnant Women on Pregnancy Stress and Fear of Childbirth
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.
- Conditions
- Threatened Premature Birth, Premature Membrane Rupture, Gestational Hypertension, Intrauterine Growth Retardation (IUGR), Placenta Previa, Hyperemesis Gravidarum - Severe
- Being tested
- Art therapy group, Control group
- Keywords
- Art Therapy, Fear, High-Risk Pregnancy, Stress
- Medical subject headings
- Fetal Membranes, Premature Rupture, Hypertension, Pregnancy-Induced, Fetal Growth Retardation, Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art therapy groupBehavioural
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.
Control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Art therapy group | Experimental | 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. Receives: Behavioral: Art therapy group |
| Control group | Other | Nothing other than routine procedures will be done to the control group. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI FORM TX)
It will be used to measure state and trait anxiety.
Measured: It will be used at the end of the 2nd week and the end of the 4th week of the study.
Pregnancy Stress Scale
It will be used to measure the stress of the pregnant woman
Measured: It will be used at the end of the 2nd week and the end of the 4th week of the study.
Fear of Birth Scale
It will be used to measure the fear of childbirth.
Measured: It will be used at the end of the 2nd week and the end of the 4th week of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start16 Sep 2024
- Primary completion16 Oct 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Threatened Premature BirthStudies 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
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Dilek Aksoy, Kocaeli University
- Investigators
- Sena Dilek Aksoy, Ph.D., Principal investigator, Kocaeli UniversitySena Ozen, Study chair, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716710
- Sponsor's protocol ID
- sdilek13
- Status last verified
- Jan 2026
- First submitted
- 29 Nov 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Clinical Activity Applied to High-Risk Pregnant Women on Pregnancy Stress and Fear of Childbirth
- ClinicalTrials.gov ID
- NCT06716710
- Acronym / sponsor ID
- sdilek13
- Conditions
- Threatened Premature Birth, Premature Membrane Rupture, Gestational Hypertension, Intrauterine Growth Retardation (IUGR), Placenta Previa, Hyperemesis Gravidarum - Severe
- Keywords
- Art Therapy, Fear, High-Risk Pregnancy, Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 4 Dec 2024 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art therapy group | Experimental | Behavioral: Art therapy groupIn 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. |
| Control group | Other | Other: Control groupNothing other than routine procedures will be done to the control group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Art therapy groupIn 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. | Behavioural | Art therapy group |
| Control groupIn 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. | Other | Control group |
Primary outcome
State-Trait Anxiety Inventory (STAI FORM TX)
Time frame: It will be used at the end of the 2nd week and the end of the 4th week of the study.
It will be used to measure state and trait anxiety.
Pregnancy Stress Scale
Time frame: It will be used at the end of the 2nd week and the end of the 4th week of the study.
It will be used to measure the stress of the pregnant woman
Fear of Birth Scale
Time frame: It will be used at the end of the 2nd week and the end of the 4th week of the study.
It will be used to measure the fear of childbirth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Background: PubMed 30097422Rondung 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sena Dilek Aksoy, Ph.D. principal investigator
Kocaeli University
Sena Ozen study chair
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art therapy group in people with Threatened Premature Birth and Premature Membrane Rupture, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI FORM TX) (time frame: It will be used at the end of the 2nd week and the end of the 4th week of the study.). 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?
On the ClinicalTrials.gov record for NCT06716710, which also lists 1 linked publication.
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 6 Jan 2026.