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临床试验/NCT04045197
NCT04045197已完成不适用

The Effect of Relaxation-Focused Nursing Care on Stress, Cortisol and Birth Week in Threat of Preterm Birth: A Randomised Controlled Trial

Hülya Özberk1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2017年8月1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
发起方
入组人数
66
试验地点
1
主要终点
Birth weeks of Intervention and Control Groups

研究概览

简要总结

Relaxation-Focused Nursing Care which is formed by using these two models is composed of; positive language, positive environment and reducing stressors. Relaxation-Focused Nursing Care, which is thought to have an effect on delaying birth, consists of four stages as a two-day program.In this study, it is aimed to determine the effect of Relaxation-Focused Nursing Care on stress level, cortisol level and birth week.

详细描述

Preterm birth is seen in 7-12% of all pregnant women and according to estimations about 15 million infants are delivered each year. Preterm birth is an extremely important problem in terms of its effects on newborn's health, mother's health, community and economy. Preterm birth causes the newborn chronic pulmonary disease; gastrointestinal, immunologic, central nervous system, auditory and visual problems; long-term motor and cardiovascular system diseases; and cognitive, visual, behavioral disorders. While preterm birth causes the women postpartum anxiety, stress and depression; it also leads to newborn intensive care costs, long-term complex health care needs for families and community and has serious consequences for public service sector such as health insurance, education, other social support systems and economy. Some factors initiate preterm birth, whereas 70-80% of them start spontaneously, remaining 20-30% has iatrogenic origin. It is reported that there is no known and effective treatment for preterm birth. It is reported in literature that stress which is one of the risk factors of preterm birth, causes preterm birth. If stress causes threat of preterm delivery, reducing stress may delay preterm birth and the complications of preterm birth on newborn and mother's health and also its economic and social burden can be reduced. National and international studies related to the effect of coping with stress on threat of preterm birth are lacking. It is thought that preterm birth can be prevented in women with threat of preterm birth through developing mechanisms to cope with stress and reducing stressors. Since nurse provides 24-hour care for woman diagnosed with the threat of preterm birth, the nursing care may be effective in this aspect.

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

Single Blind Randomised Controlled Trial

入排标准

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

入选标准

  • •to be diagnosed with TPB,
  • •to be over 18 years of age,
  • •to know Turkish and
  • •to agree to participate in the research.

排除标准

  • •diagnosis of EMR,
  • •multiple pregnancy,
  • •admission to hospital with vaginal bleeding,
  • •psychiatric, chronic and pregnancy-related disease developing,
  • •to want to quit the study at any stage after agreeing to participate in the study, and
  • •delivery at any stage after the data collection process has been completed after agreeing to participate in the trial.

研究组 & 干预措施

Intervention group

Experimental

In the intervention group; informed consent forms, Relaxation Focused Nursing Care and routine nursing care in the hospital were performed. Then data collection tools were applied.

干预措施: Relaxation Focused Nursing Care (Behavioral)

Control group

No Intervention

Women in the control group received routine nursing care in the hospital and data collection tools were applied at the same hours as the intervention group.

结局指标

主要结局

Birth weeks of Intervention and Control Groups

时间窗: 20 weeks

Comparison of birth weeks between intervention and control groups

次要结局

  • Stress level of Intervention and Control Groups(2 days)

研究者

发起方
Hülya Özberk
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hülya Özberk

Research Assistant,Deparment of Obstetric-Women's Diseases Nursing,Principal Investigator

Dokuz Eylul University

研究点 (1)

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