Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-05-27
2022-05-26
Brief Summary
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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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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
SINGLE
Study Groups
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Method 1: Sweet Marjoram Essential Oil + Grapeseed Oil with Massage
Subjects randomized will receive dilution of sweet marjoram essential oil (mixed with grapeseed oil), which will be applied topically with massage after IUD insertion.
Sweet Marjoram Essential Oil
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.
Method 2: Grapeseed Oil with Massage
Subjects randomized will grapeseed oil applied topically with massage after IUD insertion.
Grapeseed Oil
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.
Method 3: Control Group (no oil or massage)
Subjects will serve as control and no essential oils or massage will be applied.
No interventions assigned to this group
Interventions
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Sweet Marjoram Essential Oil
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.
Grapeseed Oil
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Known allergies to sweet marjoram essential oil or grapeseed oil
* Broken or irritated skin on lower abdomen
* Diagnosis of IBS/IBD
18 Years
FEMALE
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Vicki F Fresen, RNC, MSN, APNP
Role: PRINCIPAL_INVESTIGATOR
Aurora BayCare Medical Center
Locations
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Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Countries
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Other Identifiers
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20-221E (19-812)
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00104768
Identifier Type: -
Identifier Source: org_study_id