The Effect of the Clinical Activity Applied to High-Risk Pregnant Women on Pregnancy Stress and Fear of Childbirth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- State-Trait Anxiety Inventory (STAI FORM TX)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Art therapy group (Behavioral)
Control group
Nothing other than routine procedures will be done to the control group.
干预措施: Control group (Other)
结局指标
主要结局
State-Trait Anxiety Inventory (STAI FORM TX)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Sena Dilek Aksoy
Principal Investigator
Kocaeli University