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临床试验/NCT05705609
NCT05705609已完成不适用

The Effect of Mandala Art Therapy on Blood Glucose Level, Mood and Anxiety in Pregnant Women With Abnormal OGTT: A Randomized Controlled Study

Inonu University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
1
主要终点
Anxiety scores

研究概览

简要总结

The goal of this interventional study is to learn about determine the effect of mandala art therapy on blood glucose level, mood and anxiety in pregnant women with abnormal oral glucose tolerance test (OGTT) value. The main questions it aims to answer are:

  • Does mandala art therapy affect the mood of pregnant women?
  • Does mandala art therapy affect the anxiety level of pregnant women?

After measuring fasting plasma glucose and drinking oral glucose by the hospital staff in the experimental group in the outpatient clinic, after the 1st and 2nd hour measurements, a total of 2 individual mandala activities (Mandala training certificate was obtained by Dr. Lecturer Esra KARATAŞ OKYAY) will be performed by the researcher.

详细描述

The goal of this interventional study is to learn about determine the effect of mandala art therapy on blood glucose level, mood and anxiety in pregnant women with abnormal oral glucose tolerance test (OGTT) value.

Pregnant women who apply to Malatya Training and Research Hospital gynecology outpatient clinics to have OGTT and meet the criteria will be invited to the study. The women will be informed about the method to be followed in the research, the voluntary information form will be read to those who want to participate in the research, and their verbal and written permissions will be obtained. Before Mandala art therapy, a personal information form, State Meta-Mood Scale (SMMS) and State Trait Anxiety Scale (STAI) will be applied to pregnant women in both groups. All blood collection and OGTT procedures for pregnant women in the experimental and control groups will be performed by hospital staff in line with hospital procedures. After measuring fasting plasma glucose and drinking oral glucose by the hospital staff in the experimental group in the outpatient clinic, after the 1st and 2nd hour measurements, a total of 2 individual mandala activities (Mandala training certificate was obtained by one of researcher Esra KARATAŞ OKYAY) will be performed by the researcher. The blood glucose levels of the pregnant woman at the time of measurement will be recorded from the patient records. As a post-test, the State Meta-Mood Scale (SMMS) and state anxiety scale will be applied again. Any procedure other than routine care will not be applied to the pregnant women in the control group. Likewise, the blood glucose levels of the pregnant woman at the time of measurement will be recorded from the patient records. As a post-test, the State Meta-Mood Scale (SMMS) and StateTrait Anxiety Scale (STAI) will be applied again.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • at 24-28 weeks of gestation,
  • OGTT will be done,
  • Those who have not received mandala art therapy training before,
  • Does not have a physical problem that will prevent creating a mandala,
  • Actively using their hands
  • No communication problem
  • Pregnant women without learning problems were included in the sample

排除标准

  • Any problems diagnosed in pregnancy (such as oligohydramnios, preeclampsia, heart disease, diabetes, placenta previa)
  • Pregnant women diagnosed with gestational diabetes
  • Pregnant women in their first term were not included in the study.

结局指标

主要结局

Anxiety scores

时间窗: at 2nd hours after OGTT

StateTrait Anxiety Scale (STAI): The highest score from the scale is 80, the lowest score is 20. Higher STAI-I scores indicate higher state anxiety levels

次要结局

  • Mood scores(at 2nd hours after OGTT)

研究者

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

ESRA GUNEY, PhD

PhD

Inonu University

研究点 (1)

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