The Use of Topically Applied Sweet Marjoram Essential Oil for Pain Reduction Following IUD Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Pain/Discomfort as Assessed by NRS
研究概览
简要总结
This study will measure the effects of topical application of sweet marjoram essential oil + grapeseed oil with massage on uterine cramping/pain post-IUD insertion/placement.
The intention is to conduct a pilot study that could give a first look at the data to determine whether this line of research is worth pursuing with more time, effort, and resources. The results of this pilot study will provide adequate data (e.g., variance estimates) needed for obtaining reasonably reliable sample size estimates if larger studies are warranted in the future.
详细描述
Patients will be consented and randomized to one of three methods by a member of the study team on the day of their IUD insertion. Several variables of interest will be collected via the electronic medical record and via questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participant will remain blinded until completion of their study activities
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older at time of IUD insertion
- •English speaking
- •Subject has signed study-specific consent form
- •Subject has taken clinic recommended NSAID at least 30 minutes prior to IUD insertion
排除标准
- •Subject is in post-partum period
- •Known allergies to sweet marjoram essential oil or grapeseed oil
- •Broken or irritated skin on lower abdomen
- •Diagnosis of IBS/IBD
结局指标
主要结局
Change in Pain/Discomfort as Assessed by NRS
时间窗: 15 minutes post oil application/massage
Pain/discomfort rating change following topical application of sweet marjoram + grapeseed oil with massage after IUD insertion. (Pain/discomfort assessed by NRS on scale of 0-10).
次要结局
- NRS Patient Pain Rating(Within the 15 minutes following oil application/massage)