Essential Oils for Electrocautery

Not Applicable

Active, not recruiting

• Conditions: Anxiety
• Interventions: Other: Essential Oil; Other: No Essential Oil

• Registration Number: NCT04260867
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-07
• Study Start: 2020-12-22
• Primary Completion: 2021-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-02
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

1. >18 years of age
2. Receiving same day cutaneous surgical procedure that requires electrocautery per protocol
3. In good general health as assessed by the investigator
4. Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

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Exclusion Criteria

1. Surgery site incompatible with the patient holding a handheld aromatherapy device (physician discretion)
2. Subject unwilling to sign an IRB approved consent form
3. 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aromatherapy	Essential Oil	-
Sham	No Essential Oil	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Northwestern University Department of Dermatology; 🇺🇸 Chicago, Illinois, United States