Pain, Muscle, IUD
Conditions
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.
Interventions
OTHERSweet 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.
OTHERGrapeseed 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
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participant will remain blinded until completion of their study activities
Intervention model description
1:1:1 Randomization
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed