AnxietyNCT04260867
Essential Oils for Electrocautery
A study testing Essential Oil and No Essential Oil in people with Anxiety, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Essential Oil and No Essential Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2020to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
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
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.
- Conditions
- Anxiety
- Being tested
- Essential Oil, No Essential Oil
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential OilOther
Those randomized to the treatment group will have containers filled with the essential oil of their choice.
No Essential OilOther
Those randomized to the control group will then be given empty single-use handheld aromatherapy containers containing no essential oil.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy | Experimental | Not described Receives: Other: Essential Oil |
| Sham | Sham comparator | Not described Receives: Other: No Essential Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported perceptions of cautery smell on a 4-point likert scale
This is a patient-reported questionnaire about perceptions of smell.
Measured: Immediately after surgery
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
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start22 Dec 2020
- Primary completion1 Jun 2021
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260867
- Sponsor's protocol ID
- STU00211721
- Status last verified
- Jun 2026
- First submitted
- 6 Feb 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04260867
- Acronym / sponsor ID
- STU00211721
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy | Experimental | Other: Essential Oil |
| Sham | Sham comparator | Other: No Essential Oil |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential OilThose randomized to the treatment group will have containers filled with the essential oil of their choice. | Other | Aromatherapy |
| No Essential OilThose randomized to the control group will then be given empty single-use handheld aromatherapy containers containing no essential oil. | Other | Sham |
Primary outcome
Self-reported perceptions of cautery smell on a 4-point likert scale
Time frame: Immediately after surgery
This is a patient-reported questionnaire about perceptions of smell.
Patient reported anxiety State-Trait Anxiety Inventory (STAI-6)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Oil and No Essential Oil in people with Anxiety, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported perceptions of cautery smell on a 4-point likert scale (time frame: Immediately after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.