Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

Not Applicable

Completed

• Conditions: Anxiety; Anxiety State; Procedural Anxiety
• Interventions: Other: Placebo Aromatherapy; Other: Lavender Aromatherapy

• Registration Number: NCT04260399
• Lead Sponsor: Loyola University

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.

Study Timeline

• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Study Start: 2020-02-18
• Status Verified: 2021-05
• Primary Completion: 2021-05-26
• Study Completion: 2021-05-26
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Aromatherapy	Placebo Aromatherapy	Passive exposure via an ambient essential oil diffuser to saline water aromatherapy
Lavender Aromatherapy	Lavender Aromatherapy	Passive exposure via an ambient essential oil diffuser to lavender aromatherapy

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States