Clary Sage Essential Oil Inhalation and Third Trimester Quality of Life: A Randomized, Double Blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in quality of life from week 27 to 36 of the pregnancy using the World Health Organization's Quality of Life, Brief-Form Scale (WHOQOL-BREF).
研究概览
简要总结
The purpose of this study is to evaluate the potential for clary sage essential oil to support overall health, wellbeing, and quality of life during the third trimester of pregnancy among otherwise healthy adult women.
详细描述
Women will be informed of the opportunity to participate through their care providers, childbirth educators, or doulas. If they meet inclusion criteria, they will be given a brochure describing the risks and benefits of the study and the informed consent paperwork.
If they provide consent, they will be randomized to one of two groups: active essential oil and inert placebo. Both groups will receive a 4-ounce bottle of oil to apply daily during the third trimester of pregnancy. Those in the placebo group will be given an inert plant oil. Those in the intervention group will be given the same oil with the addition of clary sage essential oil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 20-39
- •Lives in the United States
- •Pregnant, singleton
- •Less than 27 weeks gestation
排除标准
- •PCOS diagnosis
- •Uncontrolled Hypertension (i.e. systolic/diastolic blood pressure > 140/90)
- •Gestational Diabetes
- •History of Preeclampsia
- •Preterm labor
- •Incompetent cervix
- •Allergy to salvia sclarea or related plants
- •Known Birth Defects
- •Thyroid Disease diagnosis
结局指标
主要结局
Change in quality of life from week 27 to 36 of the pregnancy using the World Health Organization's Quality of Life, Brief-Form Scale (WHOQOL-BREF).
时间窗: Pregnancy week 27 and 36
This one survey measures overall quality of life through. It contains 26 questions across 4 domains. Questions are scored on a 1-5 likert scale with higher scores indicating higher quality of life.
Change in salivary estriol levels from pregnancy week 27 to pregnancy week 36.
时间窗: Pregnancy week 27 and 36
salivary estriol levels are collected via the passive drool method and laboratory analyzed
次要结局
- Duration of Pregnancy(from enrollment to birth, up to 16 weeks)
- Duration of phase 2 of labor(from the onset of labor to birth, up to 24 hours)