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临床试验/NCT05780112
NCT05780112已完成不适用

Evaluation of The Effectiveness of The Breathing Exercise On The Nausea, Vomiting And Quality of Life In The Early Pregnancy Period: A Single-Blind Randomized Controlled Trial

Inonu University1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2019年6月1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
104
试验地点
1
主要终点
Nausea and Vomiting in Pregnancy Instrument (NVPI)

研究概览

简要总结

Aim: This study aimed to investigate the effectiveness of the breathing exercise on pregnancy-related nausea and vomiting and the quality of life in the early pregnancy period.

Background: Nausea and vomiting during pregnancy is a condition that can negatively affect the quality of life and the course of pregnancy in pregnant women. Nausea and vomiting during pregnancy with breathing exercises and can positively affect the quality of life women.

Methods: This study is a single-blind randomised controlled trial. The sample consisted of 104 pregnant women. The Personal Information Form, the Nausea and Vomiting in Pregnancy Instrument and the 36-Item Short-Form Health Survey were used to collected the data.

详细描述

2.1. Study design, sampling and recruitment strategies This research was conducted as a randomized controlled experimental study with the pretest-posttest design. The research was carried out in the maternity polyclinic of a public hospital affiliated with the Health Directorate of Elazığ Province in eastern Turkey in June 2019 - May 2020. A total of 104 pregnant women took part in the research (52 pregnant women in the experimental group and 52 pregnant women in the control group). In the calculation of the sample size, the power analysis was utilized. Considering that the effect of the breathing exercise on nausea and vomiting and the quality of life in the early pregnancy period will increase the mean of the Nausea and Vomiting in Pregnancy Instrument scores eight points after the breathing exercise, the number of participants for each group was calculated as 52 pregnant women at α=0.05 significance level and with 80% power [1-β (power)=0.80].

In the research, the inclusion criteria were designated as follows: a) Having the ability to communicate, b) Being aged 15-49 years, c) Being in the 12th or an earlier week of pregnancy with a living fetus, d) Not having fetal congenital malformation, e) Not having systemic diseases (gastrointestinal system, audiovestibular, endocrine, infection, and psychological diseases) which are likely to lead to nausea and vomiting other than pregnancy-related nausea and vomiting, f) never using a medication against nausea and vomiting before.

Under the research, the following were identified as the exclusion criteria: a) Having a multiple pregnancy, b) Having fetal congenital malformation, c) Having systemic diseases that are likely to lead to nausea and vomiting, d) Using medication against nausea and vomiting, e) Having the risk of miscarriage, f) Having speech disorder.

2.2. Instruments In the collection of research data, the Personal Information Form, the Nausea and Vomiting in Pregnancy Instrument, and the 36-Item Short-Form Health Survey were used. The research data were gathered by the researcher using the face-to-face interview technique.

2.2.1. Personal Information Form In the Personal Information Form which was prepared by the researcher as per the literature review (Şahan, 2012; Acog Practıce Bulletın, 2018; Köken et. al., 2009; Aksu, & Şirin 2007), seven questions addressed the pregnant women's socio-demographic characteristics (age, education, employment status, income level, body mass index-BMI) and ten questions pertained to the pregnancy (the number of previous pregnancies, whether the pregnancy was unwanted or not, the number of nausea and vomiting per day, and so on.), and hence, the form contained 17 questions in total.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Investigator)

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

  • Having the ability to communicate,
  • Being aged 15-49 years,
  • Being in the 12th or an earlier week of pregnancy with a living fetus,
  • Not having fetal congenital malformation,
  • Not having systemic diseases (gastrointestinal system, audiovestibular, endocrine, infection, and psychological diseases) which are likely to lead to nausea and vomiting other than pregnancy-related nausea and vomiting,
  • never using a medication against nausea and vomiting before.

排除标准

  • Having a multiple pregnancy,
  • Having fetal congenital malformation,
  • Having systemic diseases that are likely to lead to nausea and vomiting,
  • Using medication against nausea and vomiting,
  • Having the risk of miscarriage,
  • Having speech disorder.

结局指标

主要结局

Nausea and Vomiting in Pregnancy Instrument (NVPI)

时间窗: Change from Nausea and Vomiting in Pregnancy Instrument at 4 weeks

The Nausea and Vomiting in Pregnancy Instrument was developed by Swallow et al. (2002) for evaluating nausea and vomiting during pregnancy 'within the last week'. The NVPI was used after the time frame was re-configured as 'the week in which the pregnant woman had nausea and vomiting most frequently'. The NVPI is comprised of three questions that addressed the frequency of nausea, retching, and vomiting for one week. Each question was scored on the basis of a 6-point Likert scale. The scores to be obtained from each NVPI question ranged from 0 to 5 points, and the minimum and maximum scores to be obtained from the NVPI were respectively 0 and 15 points. There is no cut-off point for the NVPI. The increase in the NVPI scores demonstrates that the severity of nausea and vomiting rose

36-Item Short-Form Health Survey

时间窗: Change from 36-Item Short-Form Health Survey Instrument at 4 weeks

SF-36 is composed of 36 questions and eight sub-scales (physical functioning, role physical, bodily pain, general health perceptions, vitality, social functioning, role emotional, and mental health). ). Just as the SF-36 and its eight sub-scales are evaluated separately, the SF-36 can also be evaluated under two main dimensions, namely, physical dimension and mental dimension. The physical dimension covers the domains of physical functioning, role physical, bodily pain, general health perceptions, and vitality while the mental dimension includes the domains of social functioning, role emotional, mental health, general health perceptions, and vitality. For the physical and mental dimensions, the mid-range value was set as 50 points, and the scores above and below 50 points are successively categorized as being above and below the mid-range.

次要结局

未报告次要终点

研究者

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

Tülay AYTEKİN AYDIN

Women's Health and Diseases Nurse

Inonu University

研究点 (1)

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