Pregnancy Related, Quality of Life
Conditions
Keywords
clary sage, essential oil, aromatherapy
Brief summary
The purpose of this study is to evaluate the potential for clary sage essential oil to support overall health, wellbeing, and quality of life during the third trimester of pregnancy among otherwise healthy adult women.
Detailed description
Women will be informed of the opportunity to participate through their care providers, childbirth educators, or doulas. If they meet inclusion criteria, they will be given a brochure describing the risks and benefits of the study and the informed consent paperwork. If they provide consent, they will be randomized to one of two groups: active essential oil and inert placebo. Both groups will receive a 4-ounce bottle of oil to apply daily during the third trimester of pregnancy. Those in the placebo group will be given an inert plant oil. Those in the intervention group will be given the same oil with the addition of clary sage essential oil.
Interventions
OTHERClary Sage Massage Oil
This massage oil contains clary sage oil. Five drops will be used daily.
OTHERInert Massage Oil
This massage oil consists entirely of plant based oils. Five drops will be used daily.
Sponsors
Nutraceuticals Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 20-39 * Lives in the United States * Pregnant, singleton * Low risk * Less than 27 weeks gestation
Exclusion criteria
* PCOS diagnosis * Uncontrolled Hypertension (i.e. systolic/diastolic blood pressure \> 140/90) * Gestational Diabetes * History of Preeclampsia * Preterm labor * Incompetent cervix * Allergy to salvia sclarea or related plants * Known Birth Defects * Thyroid Disease diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in salivary estriol levels from pregnancy week 27 to pregnancy week 36. | Pregnancy week 27 and 36 | salivary estriol levels are collected via the passive drool method and laboratory analyzed |
| Change in quality of life from week 27 to 36 of the pregnancy using the World Health Organization's Quality of Life, Brief-Form Scale (WHOQOL-BREF). | Pregnancy week 27 and 36 | This one survey measures overall quality of life through. It contains 26 questions across 4 domains. Questions are scored on a 1-5 likert scale with higher scores indicating higher quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Pregnancy | from enrollment to birth, up to 16 weeks | The total length of the pregnancy (in days) from last menstrual period to birth. |
| Duration of phase 2 of labor | from the onset of labor to birth, up to 24 hours | The total length of phase 2 of labor (in minutes) |
Countries
United States
Outcome results
None listed