Kocaeli University
Kocaeli, 41380, Turkey (Türkiye)
NCT Number: NCT06716710
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.
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Notify Me18 year–50 year
Female
Interventional
Not applicable
Kocaeli, 41380, Turkey (Türkiye)
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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
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.
Kocaeli University
Other
The Effect of the Clinical Activity Applied to High-Risk Pregnant Women on Pregnancy Stress and Fear of Childbirth
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