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The purpose of this study is to evaluate the efficacy of lavender aromatherapy in adult patients undergoing awake otolaryngologic procedures in the outpatient clinic setting. The main questions it aims to answer are:
Researchers will compare lavender aromatherapy to placebo (an odorless liquid) to see if lavender aromatherapy helps improve patient comfort during their awake procedure
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavender Aromatherapy | Experimental | Participants will be exposed to lavender aromatherapy on a cotton ball prior to procedure, and then with a diffuser during the duration of the procedure |
|
| Placebo | Placebo Comparator | Participants will be exposed to placebo odorless liquid, on a cotton ball prior to procedure, and then with a diffuser during the duration of the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lavender Aromatherapy | Other | Lavender essential oil on cotton ball, and in aromatherapy diffuser |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in visual analog scale anxiety, measured on a 10 cm scale | A 10 cm visual analog scale is widely utilized to measure procedural anxiety, rated from 0 to 10, with 10 being the highest level of anxiety. The patient will provide a vertical mark above their level of anxiety. This number measured in mm (0-100) will be recorded both immediately before the procedure, and after the procedure, where the patient will record their average level of anxiety during the procedure. The change between pre-procedure, and post-procedure, will be recorded for each patient and compared between the lavender aromatherapy and placebo groups. The mean and median pre-procedure and post-procedure values will also be compared between the groups. | Baseline, Periprocedural and Immediately after the procedure |
| Likert scale of pain, measured on a scale of 0-10 | Patients will be asked to rate their your average level of pain on a scale of 0 (no pain) to 10 (worst possible pain) on a post-procedural questionnaire | Immediately after the procedure |
| Likert scale subjective improvement with pain, measured on scale of 1-5 | Patients will be asked in post-procedural questionnaire if they felt the aromatherapy helped with pain during the procedure, on a scale of 1 (strongly disagree) to 5 (strongly agree) | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Impressions of Lavender Aromatherapy, measured on Likert scale and in Yes/No format in post-procedural questionnaire | Patients will be asked in a post-procedural questionnaire their subjective impressions of the lavender aromatherapy or placebo. The questions will be outlined as below: Did you feel the aromatherapy was calming during the procedure? 1 2 3 4 5 (1 = strongly disagree, 5 = strongly agree) Did you find the scent pleasant? 1 2 3 4 5 (1 = strongly disagree, 5 = strongly agree) Do you use aromatherapy or essential oils regularly? Yes No Have you ever used aromatherapy or essential oils in the past? Yes No How likely are you to recommend the aromatherapy for future patients undergoing awake procedures? 1 2 3 4 5 (1 = strongly disagree, 5 = strongly agree) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dhruv S Kothari, MD | Contact | 310-560-7331 | dhruv.kothari@cshs.org | |
| Ankona Ghosh, MD | Contact | 213-300-7972 | ankona.ghosh@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Ankona Ghosh, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center Otolaryngology Clinics | Recruiting | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19962101 | Background | Braden R, Reichow S, Halm MA. The use of the essential oil lavandin to reduce preoperative anxiety in surgical patients. J Perianesth Nurs. 2009 Dec;24(6):348-55. doi: 10.1016/j.jopan.2009.10.002. | |
| 37712305 | Background | Kothari DS, Nieri CA, Tanenbaum ZG, Linker LA, Rangarajan SV. Mind-Body Therapies in the Management of Otolaryngologic Disease: A State-of-the-Art Review of Randomized Controlled Trials. Otolaryngol Head Neck Surg. 2024 Jan;170(1):45-60. doi: 10.1002/ohn.523. Epub 2023 Sep 15. |
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IPD will not be shared with other researchers in order to protect patient privacy, as these patients will be undergoing awake procedures at only 1 location, and thus their results may be identified even after anonymization or de-identification.
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| Placebo Aromatherapy | Other | Saline on cotton ball and in aromatherapy diffuser |
|
| Immediately after the procedure |
| 21649812 | Background | Grunebaum LD, Murdock J, Castanedo-Tardan MP, Baumann LS. Effects of lavender olfactory input on cosmetic procedures. J Cosmet Dermatol. 2011 Jun;10(2):89-93. doi: 10.1111/j.1473-2165.2011.00554.x. |
| 29299520 | Background | Wotman M, Levinger J, Leung L, Kallush A, Mauer E, Kacker A. The Efficacy of Lavender Aromatherapy in Reducing Preoperative Anxiety in Ambulatory Surgery Patients Undergoing Procedures in General Otolaryngology. Laryngoscope Investig Otolaryngol. 2017 Nov 8;2(6):437-441. doi: 10.1002/lio2.121. eCollection 2017 Dec. |
| ID | Term |
|---|---|
| D012223 | Rhinitis, Vasomotor |
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D013964 | Thyroid Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D013959 | Thyroid Diseases |
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