Essential Oils Following IUD Insertion

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Use of Topically Applied Sweet Marjoram Essential Oil for Pain Reduction Following IUD Placement

Conditions
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IUD, Pain, Muscle

Intervention / Treatment
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* Other: Sweet Marjoram Essential Oil
* Other: Grapeseed Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 1:1:1 Randomization
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Method 1: Sweet Marjoram Essential Oil + Grapeseed Oil with Massage<br>Subjects randomized will receive dilution of sweet marjoram essential oil (mixed with grapeseed oil), which will be applied topically with massage after IUD insertion. | Other: Sweet Marjoram Essential Oil<br>* Subjects will receive a dilution of sweet marjoram essential oil (15 cc of grapeseed oil with 10 drops of sweet marjoram essential oil). Oil will be applied topically by the study medical providers. Providers will wear exam gloves, dip three fingers into the oil solution and apply it topically to the subject's lower abdomen. This will be applied by going left to right for 20 seconds while applying gentle pressure - counter pressure may be applied on the uterus to help relieve cramping.<br>|
| Active Comparator: Method 2: Grapeseed Oil with Massage<br>Subjects randomized will grapeseed oil applied topically with massage after IUD insertion. | Other: Grapeseed Oil<br>* Subjects will receive 15 cc of undiluted grapeseed oil. Oil will be applied topically by the study medical providers. Providers will wear exam gloves, dip three fingers into the oil solution and apply it topically to the subject's lower abdomen. This will be applied by going left to right for 20 seconds while applying gentle pressure - counter pressure may be applied on the uterus to help relieve cramping.<br>|
| No Intervention: Method 3: Control Group (no oil or massage)<br>Subjects will serve as control and no essential oils or massage will be applied. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain/Discomfort as Assessed by NRS | 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). | 15 minutes post oil application/massage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS Patient Pain Rating | The secondary objective of this study is to determine ≥ 0.5-point different in perceived pain rating (on a scale of 0-10) exists between Method 1 (sweet marjoram essential oil + grapeseed oil with massage), Method 2 (grapeseed oil with massage), and Method 3 (control group - no oil or massage). | Within the 15 minutes following oil application/massage |