Essential Oils Following IUD Insertion

IUD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04927741
• Other study ID #: 20-221E (19-812)
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: March 2024

Study information

• Verified date: January 2024
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 2024
• Est. primary completion date: May 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• IUD
• Myalgia
• Pain, Muscle

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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