Essential Oils for Electrocautery

NCT ID: NCT04260867

Last Updated: 2025-01-31

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Aromatherapy

Group Type EXPERIMENTAL

Essential Oil

Intervention Type OTHER

Those randomized to the treatment group will have containers filled with the essential oil of their choice.

Sham

Group Type SHAM_COMPARATOR

No Essential Oil

Intervention Type OTHER

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.

Intervention Type OTHER

No Essential Oil

Those randomized to the control group will then be given empty single-use handheld aromatherapy containers containing no essential oil.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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STU00211721

Identifier Type: -

Identifier Source: org_study_id

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