Essential Oils for Electrocautery

Study Overview
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Brief Summary
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The purpose of this study is to assess whether essential oil aromatherapy could improve or eliminate the smell of burnt flesh from electrocautery and subsequently mitigate patient anxiety and discomfort during dermatologic skin surgery. This is a randomized clinical trial. Approximately 210 electrocautery participants will be randomized to receive sham control/no aromatherapy or aromatherapy. Patients will be asked to complete a questionnaire after completion of the procedure to assess their experience. This study was a pilot study designed to determine the feasibility of this procedure. Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be invited and considered for enrollment.

Official Title
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Utility of Aromatherapy in Reducing Burnt Flesh Smell, Decreasing Intraoperative Anxiety, and Improving the Patient's Overall Experience During Cutaneous Surgical Procedures: a Randomized Controlled Trial

Conditions
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Anxiety

Intervention / Treatment
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* Other: Essential Oil
* Other: No Essential Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years of age Receiving same day cutaneous surgical procedure that requires electrocautery per protocol In good general health as assessed by the investigator Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study Exclusion Criteria: Surgery site incompatible with the patient holding a handheld aromatherapy device (physician discretion) Subject unwilling to sign an IRB approved consent form Participants who are unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function are not eligible

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aromatherapy<br> | Other: Essential Oil<br>* Those randomized to the treatment group will have containers filled with the essential oil of their choice.<br>|
| Sham Comparator: Sham<br> | Other: No Essential Oil<br>* Those randomized to the control group will then be given empty single-use handheld aromatherapy containers containing no essential oil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported perceptions of cautery smell on a 4-point likert scale | This is a patient-reported questionnaire about perceptions of smell. | Immediately after surgery | 
| Patient reported anxiety State-Trait Anxiety Inventory (STAI-6) | Patient perioperative anxiety will be reported on the 6-item shortform of the State-Trait Anxiety Inventory (STAI-6) directly after procedure | Immediately after surgery |