Essential Oils Following IUD Insertion

NCT04927741 | Completed

• 2 other identifiers: IRB0010476820-221E (19-812)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Muscle; IUD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• NRS Patient Pain Rating

  Within the 15 minutes following oil application/massage

Study Arms (3)

Method 1: Sweet Marjoram Essential Oil + Grapeseed Oil with Massage

EXPERIMENTAL

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

Method 2: Grapeseed Oil with Massage

ACTIVE COMPARATOR

Subjects randomized will grapeseed oil applied topically with massage after IUD insertion.

Other: Grapeseed Oil

Method 3: Control Group (no oil or massage)

NO INTERVENTION

Subjects will serve as control and no essential oils or massage will be applied.

Interventions

Sweet Marjoram Essential Oil OTHER

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 1: Sweet Marjoram Essential Oil + Grapeseed Oil with Massage

Grapeseed Oil OTHER

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 2: Grapeseed Oil with Massage

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females presenting for IUD placement
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

Location

MeSH Terms

Conditions

Myalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vicki F Fresen, RNC, MSN, APNP

  Aurora BayCare Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will remain blinded until completion of their study activities
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1:1 Randomization

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 16, 2021
• Study Start: May 27, 2021
• Primary Completion: May 26, 2022
• Study Completion: May 26, 2022
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)