An interventional study of Lavender Aromatherapy and Placebo Aromatherapy in Anxiety, Anxiety State and Procedural Anxiety, sponsored by Loyola University. Completed at 1 site in United States. Open to female participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by Loyola University · Not applicable, Interventional, and Supportive care
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.
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.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 88 is close to the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Loyola University is the lead sponsor of 132 studies on the registry; 15 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 23 (88%) have results posted.
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Exclusion Criteria:
Passive exposure via an ambient essential oil diffuser to lavender aromatherapy
Other: Lavender Aromatherapy
Passive exposure via an ambient essential oil diffuser to saline water aromatherapy
Other: Placebo Aromatherapy
Participants in the experimental group will be passively exposed to lavender essential oil
Participants in the control group will be passively exposed to saline water aromatherapy
Change in state trait anxiety level
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.
Time frame: Immediate post-procedure
Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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