Pain, MuscleNCT04927741
Essential Oils Following IUD Insertion
A study testing Sweet Marjoram Essential Oil and Grapeseed Oil in people with Pain, Muscle and IUD, run by Wake Forest University Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Muscle, IUD
- What is being tested?
- Sweet Marjoram Essential Oil and Grapeseed Oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2021to 26 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
About this study
Official title: The Use of Topically Applied Sweet Marjoram Essential Oil for Pain Reduction Following IUD Placement
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.
Read the 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.
- Conditions
- Pain, Muscle, IUD
- Being tested
- Sweet Marjoram Essential Oil, Grapeseed Oil
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweet Marjoram Essential OilOther
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 OilOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 15 minutes post oil application/massage
Secondary outcomes (1)
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).
Measured: Within the 15 minutes following oil application/massage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start27 May 2021
- Primary completion26 May 2022
- Study completion26 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 1:1:1 Randomization
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vicki F Fresen, RNC, MSN, APNP, Principal investigator, Aurora BayCare Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927741
- Sponsor's protocol ID
- IRB00104768
- Other IDs
- 20-221E (19-812)
- Status last verified
- Dec 2024
- First submitted
- 3 Jun 2021
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Topically Applied Sweet Marjoram Essential Oil for Pain Reduction Following IUD Placement
- ClinicalTrials.gov ID
- NCT04927741
- Acronym / sponsor ID
- IRB00104768
- Conditions
- Pain, Muscle, IUD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 26 May 2022 (actual)
- Study completion
- 26 May 2022 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 1:1:1 Randomization
| Arm | Type | Receives |
|---|---|---|
| Method 1: Sweet Marjoram Essential Oil + Grapeseed Oil with Massage | Experimental | Other: Sweet Marjoram Essential OilSubjects randomized will receive dilution of sweet marjoram essential oil (mixed with grapeseed oil), which will be applied topically with massage after IUD insertion. |
| Method 2: Grapeseed Oil with Massage | Active comparator | Other: Grapeseed OilSubjects randomized will grapeseed oil applied topically with massage after IUD insertion. |
| Method 3: Control Group (no oil or massage) | No intervention | –Subjects will serve as control and no essential oils or massage will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sweet Marjoram Essential OilSubjects 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 | Method 1: Sweet Marjoram Essential Oil + Grapeseed Oil with Massage |
| Grapeseed OilSubjects 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. | Other | Method 2: Grapeseed Oil with Massage |
Primary outcome
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).
1 secondary outcome
NRS Patient Pain Rating
Time frame: Within the 15 minutes following oil application/massage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vicki F Fresen, RNC, MSN, APNP principal investigator
Aurora BayCare Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweet Marjoram Essential Oil and Grapeseed Oil in people with Pain, Muscle and IUD, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain/Discomfort as Assessed by NRS (time frame: 15 minutes post oil application/massage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.