Essential Oils for Electrocautery
Primary Purpose
Anxiety
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Essential Oil
No Essential Oil
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
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
Sites / Locations
- Northwestern University Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Aromatherapy
Sham
Arm Description
Outcomes
Primary Outcome Measures
Self-reported perceptions of cautery smell on a 4-point likert scale
This is a patient-reported questionnaire about perceptions of smell.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04260867
First Posted
February 6, 2020
Last Updated
February 17, 2023
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT04260867
Brief Title
Essential Oils for Electrocautery
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aromatherapy
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Essential Oil
Intervention Description
Those randomized to the treatment group will have containers filled with the essential oil of their choice.
Intervention Type
Other
Intervention Name(s)
No Essential Oil
Intervention Description
Those randomized to the control group will then be given empty single-use handheld aromatherapy containers containing no essential oil.
Primary Outcome Measure Information:
Title
Self-reported perceptions of cautery smell on a 4-point likert scale
Description
This is a patient-reported questionnaire about perceptions of smell.
Time Frame
Immediately after surgery
Title
Patient reported anxiety State-Trait Anxiety Inventory (STAI-6)
Description
Patient perioperative anxiety will be reported on the 6-item shortform of the State-Trait Anxiety Inventory (STAI-6) directly after procedure
Time Frame
Immediately after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Essential Oils for Electrocautery
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