Anxiety Reduction During Office Procedural Medicine Using Aromatherapy (AROMA)

Loyola University

Status: Completed

Conditions: Procedural Anxiety; Anxiety; Anxiety State

Treatments: Other: Lavender Aromatherapy; Other: Placebo Aromatherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04260399

213113

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups, including a placebo group

Lavender Aromatherapy

Experimental group

Description:

Passive exposure via an ambient essential oil diffuser to lavender aromatherapy

Treatment:

Other: Lavender Aromatherapy

Placebo Aromatherapy

Placebo Comparator group

Description:

Passive exposure via an ambient essential oil diffuser to saline water aromatherapy

Treatment:

Other: Placebo Aromatherapy