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临床试验/NCT06315985
NCT06315985Unknown不适用

The Effect of Classical Turkish Music on Stress and Sleep Quality in Pregnant Women Diagnosed With Preeclampsia in the Clinic

Tarsus University2 个研究点 分布在 2 个国家目标入组 142 人开始时间: 2024年3月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
142
试验地点
2
主要终点
Perceived Stress

研究概览

简要总结

Stress and Sleep of Classical Turkish Music in Pregnant Women Diagnosed with Preeclampsia in Clinics The study to be carried out to determine the effect on quality is a randomized controlled experimental research. All patients who comply with the limitations of the study and volunteer will be included in the study. When the studies in the literature are examined, there are a limited number of studies on the effects of music on pregnant women diagnosed with preeclampsia, and no studies have been found on the effects of music on stress and sleep quality in pregnant women with preeclampsia. This research aimed to determine the effect of Classical Turkish Music on stress and sleep quality in pregnant women diagnosed with Preeclampsia in clinics.

详细描述

Pregnancy is a natural process that has physiological, psychological and sociological effects on women's lives and is special and important for every woman, affecting both the person and her family (Koyucu et al., 2020; Toker, 2018; Coşkun, 2016). Maternal age, number of pregnancies and births, adverse environmental conditions such as alcohol and cigarette use, radiation, malnutrition, diseases the woman has during the pre-pregnancy period or diseases that occur during pregnancy all negatively affect the health of the mother and the fetus, leading to a risky pregnancy. (Taşkın, 2016; Toker, 2018). According to Turkey Demographic and Health Survey 2018 (TNSA, 2018) data, when births occurring in Turkey are examined, it is seen that 65.7% are in any high risk category and 35% are in at least one inevitable high risk category (TNSA , 2018).

According to the report titled "Trends in Maternal Mortality" prepared by the World Health Organization (WHO), UNICEF, UNFPA, World Bank Group and UNDESA/Population Division; In 2020, an estimated 287,000 women per year worldwide died from preventable causes related to pregnancy and childbirth, approximately 800 every day; This means that one woman dies every two minutes (UNFPA, 2023; WHO, 2023; UNICEF, 2023; WHO, 2023). According to the 2020 data of the Ministry of Health, maternal mortality rates in our country decreased to 13.1 per hundred thousand as of 2019 (Ministry of Health, 2020).

10-15% of direct maternal deaths worldwide are related to preeclampsia and eclampsia, ranking 3rd among major complications (Akolekar et al., 2013; Demirci, 2022; WHO, 2020).

According to 2019 data in our country, the first four most common causes of maternal deaths are; cardiovascular diseases (29%), embolism (16.1%), hypertension (14.2%) and bleeding (10.3%) (Maternal deaths study report, 2021; Republic of Turkey Ministry of Health Health Statistics Yearbook, 2021) . According to 2022 data of the Turkish Gynecology and Obstetrics Association, it is estimated that at least 42,000 maternal deaths annually are caused by preeclampsia (Turkish Gynecology and Obstetrics Association, 2022).

Preeclampsia; It is a pregnancy-specific disease and is a symptom characterized by hypertension (systolic blood pressure 140 mmHg and above and/or diastolic blood pressure 90 mmHg and above) and end organ dysfunction with or without proteinuria after the 20th week of pregnancy (Jung and al., 2022). Preeclampsia is a disease whose physiopathology is still not fully known. The decline in prognosis with the disappearance of the placenta after birth indicates that preeclampsia may be of placental origin (Thilaganathan & Kalafat., 2019). Preeclampsia causes dysfunction in the liver, kidney, uterus, respiratory, cerebrovascular and cardiovascular systems. If it is not diagnosed at an early stage and appropriate treatment is not provided, it may become severe in a short time and turn into eclampsia. Eclampsia is a condition that occurs with the addition of convulsions in a pregnant woman with preeclampsia symptoms, without any neurological or metabolic disease (Hansson et al., 2015; Dag et al., 2015; Günkur, 2019; Akalın & Şahin, 2018).

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

Participant will be masking.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women are hospitalized for three to five days with the diagnosis of Preeclampsia,
  • No hearing problems (as music will be played),
  • Having the appropriate level of consciousness,
  • Must be at least literate (in order to obtain consent),
  • Being over 18 years old (in order to obtain consent),
  • No communication problems,
  • Having a live fetus.
  • Pregnant women who agree to participate in the research verbally and in writing will be included in the research.

排除标准

  • Not agreeing to participate in the research verbally or in writing,
  • Illiteracy,
  • Not being under 18 years of age,
  • Having a communication problem,
  • Having a hearing problem,
  • Being hospitalized for less than three days with a diagnosis of preeclampsia,
  • Taking MgSO4
  • Having previously been diagnosed with a sleep disorder
  • Having a diagnosis of DM other than preeclampsia
  • Being hospitalized for less than three days with a diagnosis of preeclampsia,
  • The newborn is not healthy.

研究组 & 干预措施

Experimental Group

Experimental

This was a parallel group, randomized controlled trial. Experimental Group will listen to the music for three days.

干预措施: Experimental group: Listenning to the Turkish Classical Music to pregnant women diagnosed with preeclampsia (Other)

Control Group

No Intervention

Control Group will take routine care

结局指标

主要结局

Perceived Stress

时间窗: 15-30 minutes

It was developed by Cohen et al. in 1983, and Turkish validity and reliability studies were conducted by Erci in 2006. Perceived Stress Scale: 7 items containing positive statements (items 4-5-6-7-9-10 and 13) are scored in reverse and consists of 14 items in total. These items are scored by the individual on a 5-point Likert type scale (1=Never, 2=Almost never, 3=Sometimes, 4=Often, 5=Very often). The analysis of the scale is carried out on the total score. A high total score means a high Perceived Stress Level Scale. It can be said that participants whose score range is between 0-35 are at a positive stress level, can cope with stress effectively, and the coping mechanisms they use are functional. It can be said that the methods used by the participants with a score range between 36-56 are not functional and therefore they cannot cope with stress effectively.

次要结局

  • Sleep Quality(15-30 minutes)

研究者

发起方
Tarsus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulay Aksoy

Midwife, Student on master degree program at Tarsus University Midwifery Department

Tarsus University

研究点 (2)

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