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OpenTrials
Completed

NCT Number: NCT04927741

Essential Oils Following IUD Insertion

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.

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Key information

Conditions

Pain, Muscle IUD Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Pain/Discomfort as Assessed by NRS

    Time frame: 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 outcomes

  1. NRS Patient Pain Rating

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2021
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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