Intervention for Fear of Childbirth in High-Risk Pregnant Women

NCT06716710 | Completed

• 1 other identifier: sdilek13
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• State-Trait Anxiety Inventory (STAI FORM TX)

  It will be used to measure state and trait anxiety.

  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

  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.

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

Study Arms (2)

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.

Behavioral: Art therapy group

Control group

OTHER

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

Other: Control group

Interventions

Art therapy group BEHAVIORAL

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.

Art therapy group

Control group OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 30097422 BACKGROUND

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture; Hypertension, Pregnancy-Induced; Fetal Growth Retardation; Placenta Previa

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Placenta Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Sena Dilek Aksoy, Ph.D.

  Kocaeli University

  PRINCIPAL INVESTIGATOR

• Sena Ozen

  Kocaeli City Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: September 16, 2024
• Primary Completion: October 16, 2025
• Study Completion: December 16, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)