Essential Oils Following IUD Insertion

Not Applicable

Completed

• Conditions: IUD; Pain, Muscle

• Registration Number: NCT04927741
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study Start: 2021-05-27
• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Primary Completion: 2022-05-26
• Study Completion: 2022-05-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in Pain/Discomfort as Assessed by NRS	15 minutes post oil application/massage	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

Name	Time	Method
NRS Patient Pain Rating	Within the 15 minutes following oil application/massage	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).

Trial Locations

Locations (1)

Aurora BayCare Medical Center; 🇺🇸 Green Bay, Wisconsin, United States