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Essential Oils Following IUD Insertion

NCT04927741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-31

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Vicki F Fresen, RNC, MSN, APNP · Aurora BayCare Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2022-05-26
Completion
2022-05-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04927741 on ClinicalTrials.gov