Clinical trial NCT04260399: Anxiety Reduction During Office Procedural Medicine Using Aromatherapy
Official title: AROMA Study: Anxiety Reduction During Office Procedural Medicine Using Aromatherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Anxiety State
Procedural Anxiety
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized to lavender aromatherapy or saline placebo aromatherapy using a 1:1 random block allocation
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in state trait anxiety level
timeFrame: Immediate post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola Medical Center
name: Thythy Pham, MD
role: PRINCIPAL_INVESTIGATOR
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