Essential Oils Following IUD Insertion
Primary Purpose
Pain, Muscle, IUD
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sweet Marjoram Essential Oil
Grapeseed Oil
Sponsored by
About this trial
This is an interventional other trial for Pain, Muscle
Eligibility Criteria
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
Sites / Locations
- Aurora BayCare Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Method 1: Sweet Marjoram Essential Oil + Grapeseed Oil with Massage
Method 2: Grapeseed Oil with Massage
Method 3: Control Group (no oil or massage)
Arm Description
Subjects randomized will receive dilution of sweet marjoram essential oil (mixed with grapeseed oil), which will be applied topically with massage after IUD insertion.
Subjects randomized will grapeseed oil applied topically with massage after IUD insertion.
Subjects will serve as control and no essential oils or massage will be applied.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04927741
Brief Title
Essential Oils Following IUD Insertion
Official Title
The Use of Topically Applied Sweet Marjoram Essential Oil for Pain Reduction Following IUD Placement
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 27, 2021 (Actual)
Primary Completion Date
May 26, 2022 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurora Health Care
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Muscle, IUD
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
1:1:1 Randomization
Masking
Participant
Masking Description
Participant will remain blinded until completion of their study activities
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Method 1: Sweet Marjoram Essential Oil + Grapeseed Oil with Massage
Arm Type
Experimental
Arm Description
Subjects randomized will receive dilution of sweet marjoram essential oil (mixed with grapeseed oil), which will be applied topically with massage after IUD insertion.
Arm Title
Method 2: Grapeseed Oil with Massage
Arm Type
Active Comparator
Arm Description
Subjects randomized will grapeseed oil applied topically with massage after IUD insertion.
Arm Title
Method 3: Control Group (no oil or massage)
Arm Type
No Intervention
Arm Description
Subjects will serve as control and no essential oils or massage will be applied.
Intervention Type
Other
Intervention Name(s)
Sweet Marjoram Essential Oil
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Grapeseed Oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain/Discomfort as Assessed by NRS
Description
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).
Time Frame
15 minutes post oil application/massage
Secondary Outcome Measure Information:
Title
NRS Patient Pain Rating
Description
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).
Time Frame
Within the 15 minutes following oil application/massage
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females presenting for IUD placement
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicki F Fresen, RNC, MSN, APNP
Organizational Affiliation
Aurora BayCare Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Essential Oils Following IUD Insertion
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