Essential Oils for Electrocautery

NCT04260867 | Active Not Recruiting

• 1 other identifier: STU00211721
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Aromatherapy

EXPERIMENTAL

Other: Essential Oil

Sham

SHAM COMPARATOR

Other: No Essential Oil

Interventions

Essential Oil OTHER

Those randomized to the treatment group will have containers filled with the essential oil of their choice.

Aromatherapy

No Essential Oil OTHER

Those randomized to the control group will then be given empty single-use handheld aromatherapy containers containing no essential oil.

Sham

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Oils, Volatile

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 7, 2020
• Study Start: December 22, 2020
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)