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This goal of this study is to assess whether lavender aromatherapy during gynecologic and urogynecologic outpatient procedures is associated with a decrease in patient anxiety levels. Based on similar interventions in other specialties of medicine, the investigators hypothesize that patients exposed to lavender aromatherapy during their procedure will have less anxiety than those who are not exposed to lavender aromatherapy.
Patients who present to the Loyola Urogynecology office for an outpatient procedure will be invited to participate. Patients who consent to participate will be asked to complete pre-procedure questionnaires including an assessment of their level of procedural anxiety. Subsequently, patients will be randomized to receive either lavender aromatherapy or saline aromatherapy (placebo) during their procedure. Post-procedural levels of anxiety will then be assessed. Changes between pre- and post-procedural anxiety will be compared between the treatment and placebo control groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavender Aromatherapy | Experimental | Passive exposure via an ambient essential oil diffuser to lavender aromatherapy |
|
| Placebo Aromatherapy | Placebo Comparator | Passive exposure via an ambient essential oil diffuser to saline water aromatherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lavender Aromatherapy | Other | Participants in the experimental group will be passively exposed to lavender essential oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in state trait anxiety level | Participants' change in state anxiety from pre-procedure to post-procedure will be measured using the State-Trait Anxiety Inventory (STAI-Y1). The STAI-Y1 is a 20 item questionnaire that asks participants to rate their state anxiety. The scale ranges from 20 to 80 points with higher scores indicating worse anxiety. The change score is calculated by subtracting the pre-procedure STAY-YI score from the post-procedure STAY-YI score to create a delta STAI-Y1 score. | Immediate post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thythy Pham, MD | Loyola Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20888947 | Background | Bailey L. Strategies for decreasing patient anxiety in the perioperative setting. AORN J. 2010 Oct;92(4):445-57; quiz 458-60. doi: 10.1016/j.aorn.2010.04.017. | |
| 14616277 | Background | Hilden M, Sidenius K, Langhoff-Roos J, Wijma B, Schei B. Women's experiences of the gynecologic examination: factors associated with discomfort. Acta Obstet Gynecol Scand. 2003 Nov;82(11):1030-6. doi: 10.1034/j.1600-0412.2003.00253.x. |
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There is no plan to make individual participant data (IPD) available to other researchers
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Patients are randomized to lavender aromatherapy or saline placebo aromatherapy using a 1:1 random block allocation
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This trial is not blinded
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| Placebo Aromatherapy | Other | Participants in the control group will be passively exposed to saline water aromatherapy |
|
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