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Anxiety Reduction During Office Procedural Medicine Using Aromatherapy (AROMA)

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ClinicalTrials.gov Identifier: NCT04260399
Recruitment Status : Completed
First Posted : February 7, 2020
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Thythy Pham, 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.

Condition or disease Intervention/treatment Phase
Anxiety Anxiety State Procedural Anxiety Other: Lavender Aromatherapy Other: Placebo Aromatherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients are randomized to lavender aromatherapy or saline placebo aromatherapy using a 1:1 random block allocation
Masking: None (Open Label)
Masking Description: This trial is not blinded
Primary Purpose: Supportive Care
Official Title: AROMA Study: Anxiety Reduction During Office Procedural Medicine Using Aromatherapy
Actual Study Start Date : February 18, 2020
Actual Primary Completion Date : May 26, 2021
Actual Study Completion Date : May 26, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Lavender Aromatherapy
Passive exposure via an ambient essential oil diffuser to lavender aromatherapy
Other: Lavender Aromatherapy
Participants in the experimental group will be passively exposed to lavender essential oil

Placebo Comparator: Placebo Aromatherapy
Passive exposure via an ambient essential oil diffuser to saline water aromatherapy
Other: Placebo Aromatherapy
Participants in the control group will be passively exposed to saline water aromatherapy




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260399


Locations
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United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
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Principal Investigator: Thythy Pham, MD Loyola Medical Center
Publications:

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Responsible Party: Thythy Pham, Assistant Professor, Loyola University
ClinicalTrials.gov Identifier: NCT04260399    
Other Study ID Numbers: 213113
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders