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临床试验/NCT03513536
NCT03513536已完成不适用

The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life

Nutraceuticals Research Institute2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2018年4月15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
74
试验地点
2
主要终点
Change from Nausea and Vomiting 6-part Quantification of Emesis scale

研究概览

简要总结

This study evaluates the effects of essential oils on nausea, vomiting, and quality of life scores among pregnant women. Participants will receive either an essential oil roll-on product or a placebo product to apply to their temples and jaw line daily for 6 days.

详细描述

The inhalation of certain essential oils has been found to reduce feelings of nausea and to improve quality of life during pregnancy.

The essential oils used in this study are applied topically to the temples and jaw line every 4-6 waking hours over a 6-day period. Each application will produce an exposure that lasts up to 30-45 minutes before fading. At the end of each day, nausea and vomiting levels will be assessed using a validated measurement instrument.

Quality of life is measured using a 30-question tool that measures both pregnancy-related quality of life and pregnancy-induced nausea and vomiting.

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 (Participant, Care Provider)

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

  • age: 18-45 years
  • confirmed pregnancy
  • healthy pregnancy

排除标准

  • hyperemesis gravidarum
  • tobacco use in the home
  • high risk pregnancy

结局指标

主要结局

Change from Nausea and Vomiting 6-part Quantification of Emesis scale

时间窗: daily for 6 days

Nausea and vomiting are measured once per day using the 6-item Quantification of Emesis 24-hour scale (PUQE) scale. This scale includes 3 questions which are ranked on a scale of 1-5, with higher scores indicating higher levels of pregnancy-induced nausea and vomiting. The other 3 questions are open-ended questions which ask participants about perceived well-being.

次要结局

  • Health Related Quality of Life for Nausea and Vomiting of Pregnancy 30-part scale(baseline and day 6)

研究者

发起方
Nutraceuticals Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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