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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
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

First Posted
February 6, 2020
Last Updated
February 17, 2023
Sponsor
Northwestern University
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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

Learn more about this trial

Essential Oils for Electrocautery

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