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临床试验/NCT06442813
NCT06442813尚未招募不适用

Effects Of Emotional Freedom Technique and Hypermesis Gravidarum

Bezmialem Vakif University2 个研究点 分布在 2 个国家目标入组 74 人开始时间: 2024年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
74
试验地点
2
主要终点
Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24)

研究概览

简要总结

The purpose of this clinical study is to determine whether EFT (Emotional Freedom Techniques) is effective in alleviating nausea and vomiting in pregnant women with hyperemesis. Additionally, the study aims to gather information on the safety of EFT application. The primary questions it seeks to answer are:

Does EFT reduce nausea and vomiting in pregnant women with hyperemesis? Is EFT applicable for use in pregnant women with hyperemesis? Researchers will compare the effectiveness of EFT to traditional nursing education on non-pharmacological interventions for preventing nausea and vomiting in pregnant women with hyperemesis.

Participants:

Pre-EFT application survey scale questions will be asked to the pregnant women with hyperemesis.

EFT will be applied once by the researcher to the pregnant women with hyperemesis.

For control, the same survey scale questions will be asked to the same pregnant women two days after the EFT application for post-test purposes.

For control, the same survey scale questions will be asked to the same pregnant women seven days after the EFT application for post-test purposes.

The same procedures will be applied in the same manner to the control group that will receive education.

详细描述

Type of Research: It is planned to be randomized, controlled and experimental. Place and Characteristics of the Research: The research will be carried out in the women health and diseases service and Gynecology polyclinics of Bezmialem Vakif University Faculty of Medicine Central Hospital.

Population and Sample of the Research:The sample size was determined as a minimum of 74 people in total using the G Power 3.1 method. The effect size was determined using the t test values in the reference study in which the scale was used with a similar patient group.

Criteria for Inclusion in the Study:Pregnant women who are between 6 and 14 weeks of gestation, aged between 20 and 40 years old, and have complaints of nausea and vomiting are eligible for the study. These participants should report their discomfort as 5 or above on the VAS scale. Additionally, they must not have been diagnosed with a high-risk pregnancy or any psychological disorders. Lastly, they must voluntarily agree to participate in the study.

Criteria for Exclusion from the Study: Exclusion criteria are the presence of coordination and language problems in the pregnant woman and her desire to leave the study at any time or not to participate.

Survey Scales Descriptive Information Form: The pregnancy information form, prepared in line with the literature review conducted by the researchers, includes socio-demographic (age of the pregnant woman, education and employment status, income level, family type and place of residence), obstetric (current gestational week and pregnancy history), psychosocial information. It consists of questions about social and medical history (pregnancy desire), whether there is a chronic disease) and VAS Scale. VAS is a measurement tool used to measure both pain intensity and pain relief, which is simple, effective and repeatable and requires minimal tools.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women between 6-14 weeks of pregnancy
  • Pregnant women between the ages of 20-40
  • Pregnant women with complaints of nausea and vomiting
  • Pregnant women who report their discomfort as 5 or above on the vas scale
  • Pregnant women who have not been diagnosed with risky pregnancy
  • Pregnant women who do not have any psychological disorders
  • Pregnant women who voluntarily agreed to participate in the research

排除标准

  • Coordination and language problems in the pregnant woman
  • Wants to leave the study at any time
  • Not wanting to participate in the study

结局指标

主要结局

Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24)

时间窗: 3 months

The degree of reduction in the severity of nausea and vomiting. The PUQE-24 (Pregnancy-Unique Quantification of Emesis and Nausea) scale is used, where each question is scored between 1 and 5. The total score is the sum of these three questions. Minimum Score: 3 (each question scoring 1) Maximum Score: 15 (each question scoring 5) These scores are used to rate the severity of nausea and vomiting in pregnancy. Lower scores indicate milder symptoms, while higher scores indicate more severe symptoms.

次要结局

  • WHOQOL-BREF (World Health Organization Quality of Life - BREF)(3 months)

研究者

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

Merve Meşedüzü

LECTURER

Bezmialem Vakif University

研究点 (2)

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