Essential Oils for Electrocautery

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04260867
• Other study ID #: STU00211721
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 22, 2020
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 111
• Est. completion date: December 2024
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Essential Oil
Those randomized to the treatment group will have containers filled with the essential oil of their choice.
• No Essential Oil
Those randomized to the control group will then be given empty single-use handheld aromatherapy containers containing no essential oil.

Locations

Country	Name	City	State
United States	Northwestern University Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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