Anxiety
Conditions
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.
Interventions
OTHEREssential Oil
Those randomized to the treatment group will have containers filled with the essential oil of their choice.
OTHERNo Essential Oil
Those randomized to the control group will then be given empty single-use handheld aromatherapy containers containing no essential oil.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Countries
United States
Outcome results
None listed