Anxiety, Anxiety State, Procedural Anxiety
Conditions
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.
Interventions
Participants in the experimental group will be passively exposed to lavender essential oil
OTHERPlacebo Aromatherapy
Participants in the control group will be passively exposed to saline water aromatherapy
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This trial is not blinded
Intervention model description
Patients are randomized to lavender aromatherapy or saline placebo aromatherapy using a 1:1 random block allocation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in state trait anxiety level | Immediate post-procedure | 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. |
Countries
United States
Outcome results
None listed