跳至主要内容
临床试验/NCT07688629
NCT07688629已完成不适用

Multidimensional Assessment of Nausea in Pregnancy: A Three-Arm Randomized Controlled Study on the Effects of Quince and Acupressure

Antalya Bilim University1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2025年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
246
试验地点
1
主要终点
Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24) Score

研究概览

简要总结

Nausea and vomiting during pregnancy are common, affecting a large proportion of women (approximately 50-75%). This symptom usually begins in the first trimester and is mostly mild or moderate; however, in some cases, it impairs quality of life, reduces nutritional intake, leads to emotional distress, and, rarely, can develop into serious conditions such as hyperemesis gravidarum.

Pharmacological approaches can be effective, especially in severe cases; however, the fear of drug-related side effects among many pregnant women and physicians is a limiting factor in drug use. Therefore, the role of complementary and non-pharmacological approaches is gaining importance, particularly in pregnant women with mild to moderate nausea. On the other hand, acupressure (especially P6/Neiguan point stimulation) is a non-invasive complementary practice whose effect in reducing nausea and vomiting during pregnancy is debated. Meta-analyses report that acupressure can significantly reduce nausea symptoms in pregnancy. However, there is a need for clearer results in the literature due to methodological differences, variability in effect sizes, and low quality scores of some studies.

Quince (Cydonia oblonga), on the other hand, is not as researched an option as acupressure in the literature for managing nausea in pregnancy. In a study comparing quince syrup with vitamin B6 in the literature, quince was found to be a more effective application than vitamin B6. Quince may theoretically have the potential to reduce nausea due to its positive effects on gastrointestinal motility, its stomach-soothing properties, and its antioxidant compound content. However, randomized controlled trials proving this effect in terms of safety and efficacy during pregnancy are limited.

Nausea during pregnancy not only causes physical discomfort but also reduces quality of life, negatively affects self-care behaviors, and can increase perceived stress levels. Therefore, nausea management should aim not only at symptom reduction but also at supporting the holistic well-being of the pregnant woman. In this context, psychosocial indicators such as the Quality of Life in Pregnancy Scale, Self-Care Ability Scale, and Perceived Prenatal Stress Scale are important in revealing not only the physiological but also the psychological and behavioral effects of complementary practices.

Therefore, examining the effects of quince and acupressure applications on not only the severity of nausea but also on quality of life, self-care ability, and perceived stress levels in pregnant women with mild to moderate nausea will fill the gap in the literature and contribute to the identification of evidence-based, safe, and applicable complementary approaches in the management of nausea in pregnancy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

This study is designed as a single-blind randomized controlled trial. The physician responsible for participant follow-up and eligibility assessment, as well as the statistician performing data analysis, will be blinded to group allocation. Participants and researchers delivering the interventions cannot be blinded due to the nature of the interventions.

入排标准

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

入选标准

  • Pregnant women aged 18-35 years
  • Gestational age between 6 and 14 weeks
  • Singleton pregnancy
  • Mild to moderate nausea and vomiting of pregnancy as assessed by the PUQE-24 scale
  • Nausea and vomiting not requiring hospitalization or pharmacological treatment
  • No known gastrointestinal disease
  • Ability to understand study procedures and provide informed consent
  • Willingness to participate and comply with study procedures

排除标准

  • Severe nausea and vomiting requiring hospitalization
  • Nausea and vomiting requiring pharmacological treatment
  • Multiple pregnancy
  • Threatened miscarriage
  • Known gastrointestinal disease
  • Withdrawal of consent at any stage of the study

结局指标

主要结局

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

时间窗: Baseline (Day 0), Daily During Intervention (Days 1-7), and Follow-up (Days 8-14)

Assessment of the severity of nausea and vomiting during pregnancy using the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE-24) scale. Higher scores indicate more severe symptoms. PUQE-24 Assessment Scale: Lowest Score (0 - 3): Mild nausea and vomiting. Moderate Score (4 - 6): Moderate nausea and vomiting. Highest Score (7 - 15): Severe nausea and vomiting.

次要结局

  • Prenatal Perceived Stress Scale Score(Baseline (Day 0) and End of Intervention (Day 7))

研究者

发起方
Antalya Bilim University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验