Aromatherapy as Treatment for Nausea and Vomiting of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Mean difference in Pregnancy-Unique Quantification of Emesis (PUQE) score
研究概览
简要总结
A double-blinded randomized controlled trial comparing essential oil aromatherapy versus placebo for treatment of first trimester nausea and vomiting of pregnancy.
详细描述
This is a double-blinded randomized controlled trial investigating the utility of essential oils for aromatherapy, compared to placebo, for treatment of nausea and vomiting in the first trimester of 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 (Participant, Investigator)
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
- •Pregnancy at <14 weeks gestation
- •English-speaking
- •Baseline PUQE score >=6
排除标准
- •Non-compliant with prenatal care or study procedures
- •Hyperemesis gravidarum
- •Allergies to perfumes, essential oils or cosmetics
- •Abnormal sense of smell
- •Known acute or chronic GI disease
- •Use of prescription anti-emetics
结局指标
主要结局
Mean difference in Pregnancy-Unique Quantification of Emesis (PUQE) score
时间窗: First trimester of pregnancy
PUQE score is a validated measure of nausea and vomiting in pregnancy. It is a reliable tool used to measure the severity of nausea and vomiting of pregnancy. It is a questionnaire that measures the number of times in 24 hours a patient wretches, vomits, or feels nauseous. The minimum score is 3, and the maximum is 15. Participants will have PUQE scores calculated at baseline (during enrollment in the first trimester of pregnancy, at whatever age they are at), and after one month of aromatherapy use with either essential oils or placebo, with the mean difference from baseline compared as primary outcome. The Time Frame for participation will be from enrollment until the end of the first trimester (13th week of pregnancy), which, depending on gestational age in weeks at enrollment, may be up to 8 weeks.
次要结局
未报告次要终点