跳至主要内容
临床试验/NCT06925841
NCT06925841已完成不适用

The Effect of Mother-Baby Themed Coloring on Stress, Anxiety, and Psychosocial Health in Pregnant Women Diagnosed With Preeclampsia: A Randomized Controlled Trial

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年3月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Anxiety

研究概览

简要总结

Preeclampsia is one of the major causes of maternal and neonatal mortality and morbidity, affecting approximately 3-5% of pregnancies. A diagnosis of preeclampsia may lead to psychological problems such as psychosocial distress, depression, and anxiety due to prolonged hospitalization, concerns about the future health of the baby, separation from family, and adapting to a foreign environment. Health professionals play a crucial role in the diagnosis, treatment, and care of high-risk pregnancies and also implement non-pharmacological supportive methods such as yoga, progressive muscle relaxation, and mindfulness. One of these non-pharmacological methods is mandala. According to the literature, integrating mandala coloring into perinatal care is believed to have beneficial effects.

Therefore, the primary aim of this study is to investigate the effects of mother-baby themed coloring on anxiety. The secondary aim is to determine its effects on psychosocial health and cortisol levels.

H1a: Is there a difference between anxiety scores in preeclamptic pregnant women who were and were not exposed to dyeing activity?

H1b: Is there a difference between psychosocial health scores in preeclamptic pregnant women who were and were not exposed to dyeing activity?

H1c: Is there a difference between cortisol levels in preeclamptic pregnant women who were and were not exposed to dyeing activity?

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Having a single and healthy fetus
  • •Gestational age ≥ 20 weeks
  • •Diagnosed with preeclampsia by a physician
  • •Not having a history of treated pregnancy

排除标准

  • •Using psychiatric medication (self-report)
  • •Receiving psychological counseling during the intervention
  • •Diagnosed with severe preeclampsia

研究组 & 干预措施

Mother and Baby Themed Coloring Activity

Experimental

Participants in this intervention group will color mother-and-baby-themed images provided by the researcher using a free coloring technique. In addition to routine care, each pregnant woman will participate in a structured 30-minute coloring activity each day.

干预措施: Experimental (Other)

Routine care

Active Comparator

The patients in the control group will receive only routine care and treatment.

干预措施: routine care (Other)

结局指标

主要结局

Anxiety

时间窗: nine months

The State-Trait Anxiety Inventory was used to determine the anxiety level. The scale consists of a total of 40 items, with 20 items for state anxiety and 20 items for trait anxiety. In this study, the state anxiety section of the scale will be used. The scale is a four-point Likert-type, with items scored between 1 and 4 (1 = not at all, 2 = a little, 3 = quite a bit, 4 = completely). The score range for each subscale is between 20 and 80 points. Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20, 21, 26, 27, 30, 33, 36, and 39 are positively worded and do not express anxiety. Therefore, these items are reverse coded during the analysis phase. As the score obtained from the scale increases, the level of anxiety also increases.

次要结局

  • Psychosocial health(nine months)
  • Cortisol(nine months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sibel Kıyak

Assist. Professor

Necmettin Erbakan University

研究点 (1)

Loading locations...

相似试验