Essential Oils for Electrocautery

• Sponsor: Northwestern University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04260867
• Collaborator: (none)
• Enrollment: 210
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13.3
• Patients Per Site Per Month: 15.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety	Other: Essential Oil; Other: No Essential Oil	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 22, 2020
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Feb 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Department of Dermatology	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Murad Alam, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Murad Alam, Professor of Dermatology, Northwestern University
• ClinicalTrials.gov Identifier: NCT04260867
• Other Study ID Numbers: STU00211721
• First Posted: Feb 7, 2020
• Last Update Posted: Dec 23, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Dec 23, 2021