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临床试验/NCT06265935
NCT06265935尚未招募不适用

The Effect of Diaphragmatic Breathing Exercise on Fatigue and Quality of Life in Pregnant Women With Gestational Diabetes

Ataturk University0 个研究点目标入组 2 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
2
主要终点
SF-36 Quality of Life Scale:

研究概览

简要总结

Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. GDM, which is in the high-risk pregnancy category, causes fatigue during pregnancy due to both hormonal changes and pregnancy complications (1). Fatigue is a general complaint that occurs in almost all physical and mental diseases. Fatigue also negatively affects an individual's well-being, daily performance, activities of daily living (ADLs) and relationships. Fatigue is one of the symptoms that, if not controlled, negatively affects the individual's daily living activities and quality of life (2). While breathing itself is a way of relaxation, it is also a part of all relaxation exercises and is an exercise that can be used in daily life. Breathing correctly and deeply is the first step in learning to relax. (3). It is important to identify fatigue, minimize it, plan daily living activities and improve quality of life in patients with GDM. This study will be conducted as a randomized controlled study to determine the fatigue and quality of life of diaphragmatic breathing exercises, one of the non-pharmacological methods, on pregnant women with gestational diabetes.

详细描述

It will be carried out as a randomized controlled experimental design to determine the fatigue and quality of life of pregnant women with gestational diabetes.

Material and method of the research:

Type of Study: This research is a randomized controlled study.

Research Questions/Hypotheses:

Hypothesis 0 (H0): Diaphragmatic breathing exercise has no effect on fatigue and quality of life in pregnant women with gestational diabetes.

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
Single (Participant)

盲法说明

The sample size was calculated as 60 pregnant women by performing GPower analysis, taking into account the tests to be used to calculate the minimum sample size to be included in the study. The sampling will include a total of 60 primiparous pregnant women, including 30 pregnant women diagnosed with gestational diabetes who meet the inclusion criteria for the study, who agree to participate in the study, and 30 pregnant women diagnosed with gestational diabetes who are applied diaphragmatic breathing exercise and who are not applied diaphragmatic breathing exercise.

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Being between the ages of 19-35,
  • During the pregnancy week,
  • Being a single and live fetus,
  • No reading and writing problems, no mental disabilities or communication problems.

排除标准

  • Multiple pregnancy,
  • Fetal congenital malformation,
  • Having a diagnosed disease other than GDM
  • There is a risk of miscarriage during pregnancy,

研究组 & 干预措施

Experimental Group

Experimental

Breathing exercise will be explained to the pregnant woman, taught and applied for 5 minutes. When doing the diaphragmatic breathing exercise, you will be told to take chest breaths after 4-5 diaphragmatic breaths to prevent hyperventilation. Feedback will be received, questions will be answered, a training brochure will be given and the program will be completed. Pregnant women will be asked to bring the questionnaire with them to their follow-up in two weeks. The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be refilled. How he did the exercise, whether he felt any effects and his satisfaction will be questioned. Your questions will be answered. You will be notified that you need to come for a check-up again in two weeks. Visual Similarity Scale for Fatigue and SF-36 Quality of Life Scale will be completed.

干预措施: Experimental Group (Behavioral)

Control Group

No Intervention

No treatment will be performed on the participants in the control group, and they will be asked not to engage in regular physical activity or sports for 4 weeks and not to make any changes in their living habits.

Pregnant women will be asked to bring the survey form with them at the follow-up visits two weeks later. The Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be refilled. You will be notified that you need to come for a check-up again in two weeks. At the follow-up after the fourth week, the Visual Similarity Scale for Fatigue and the SF-36 Quality of Life Scale will be filled out again. At the end of thirty days, the program will be completed and the forms will be filled.

结局指标

主要结局

SF-36 Quality of Life Scale:

时间窗: SF-36 Quality of Life Scale: Scale scores are expressed as a continuous variable ranging from 0 to 100. Zero indicates bad health, 100 indicates well-being.

Experimental group

次要结局

  • Visual Similarity Scale for Fatigue(The highest score that can be obtained from the Fatigue subscale is 130 and the lowest score is 0. A high score from the Fatigue subscale and a low score from the Energy subscale indicate that the severity of fatigue is high.)

研究者

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

Neslihan Atli

midwife

Ataturk University

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