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OpenTrials
Completed

NCT Number: NCT04260399

Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

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.

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Key information

Conditions

Anxiety Anxiety Disorders Anxiety State Mental Disorders Procedural Anxiety

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lavender aromatherapy

Other

Participants in the experimental group will be passively exposed to lavender essential oil

Placebo Aromatherapy

Other

Participants in the control group will be passively exposed to saline water aromatherapy

Primary outcomes

  1. Change in state trait anxiety level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Loyola University

Other

Registry information

Official study title

AROMA Study: Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

Acronym: AROMA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2020
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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