Essential Oils Following IUD Insertion

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: IUD; Pain, Muscle
• Intervention / Treatment: Other: Sweet Marjoram Essential Oil; Other: Grapeseed Oil

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54311
      • Aurora BayCare Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: Method 2: Grapeseed Oil with Massage; Subjects randomized will grapeseed oil applied topically with massage after IUD insertion.	Other: 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.
No Intervention: Method 3: Control Group (no oil or massage); Subjects will serve as control and no essential oils or massage will be applied.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aurora Health Care
• Investigators: Principal Investigator: Vicki F Fresen, RNC, MSN, APNP, Aurora BayCare Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2021
• Primary Completion (Actual): May 26, 2022
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia
• Other Study ID Numbers: 20-221E (19-812)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No