Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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AROMA Study: Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

Conditions
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Anxiety, Anxiety State, Procedural Anxiety

Intervention / Treatment
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* Other: Lavender Aromatherapy
* Other: Placebo Aromatherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing the following gynecologic/urogynecologic office procedures: colposcopy, loop electrical excision procedure (LEEP), endometrial biopsy, intrauterine device (IUD) insertion, hysteroscopy, Nexplanon removal, cystoscopy, urodynamics, botox intravesical injection, and transurethral bulking injection English speaking Ability to complete questionnaires Exclusion Criteria: Pregnancy Allergy to lavender scent Lung disease including asthma or chronic lung disease Anosmia or problems related to smell Chronic headaches or migraines Inability to complete questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized to lavender aromatherapy or saline placebo aromatherapy using a 1:1 random block allocation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lavender Aromatherapy<br>Passive exposure via an ambient essential oil diffuser to lavender aromatherapy | Other: Lavender Aromatherapy<br>* Participants in the experimental group will be passively exposed to lavender essential oil<br>|
| Placebo Comparator: Placebo Aromatherapy<br>Passive exposure via an ambient essential oil diffuser to saline water aromatherapy | Other: Placebo Aromatherapy<br>* Participants in the control group will be passively exposed to saline water aromatherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |