Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
111 participants
INTERVENTIONAL
2020-12-22
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aromatherapy
Essential Oil
Those randomized to the treatment group will have containers filled with the essential oil of their choice.
Sham
No Essential Oil
Those randomized to the control group will then be given empty single-use handheld aromatherapy containers containing no essential oil.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Responsible Party
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Murad Alam
Professor of Dermatology
Principal Investigators
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Murad Alam, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University Department of Dermatology
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00211721
Identifier Type: -
Identifier Source: org_study_id
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