Efficacy of Lavender Aromatherapy on Anxiety and Pain Reduction During Awake Otolaryngologic Procedures

Efficacy Of Lavender Aromatherapy on Anxiety and Pain Reduction During Awake Otolaryngologic Procedures

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:

• Does lavender aromatherapy help reduce anxiety and/or pain, and improve patient comfort during awake otolaryngologic procedures in the clinic?
• Do patients subjectively find aromatherapy relaxing and/or beneficial during the procedure?

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:

• Have their scheduled procedure performed with lavender aromatherapy or placebo during the duration of the procedure
• Take a short, less than 1 minute questionnaire both before and after the procedure, describing their levels of anxiety, pain and subjective impressions of the aromatherapy

Study Overview

• Status: Recruiting
• Conditions: Rhinitis, Vasomotor; Thyroid Nodules; Inferior Turbinate Hypertrophy; Vocal Fold Immobility; Chronic Rhinosinusitis (CRS)
• Intervention / Treatment: Other: Lavender Aromatherapy; Other: Placebo Aromatherapy

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dhruv S Kothari, MD; Phone Number: 310-560-7331; Email: dhruv.kothari@cshs.org
• Study Contact Backup: Name: Ankona Ghosh, MD; Phone Number: 213-300-7972; Email: ankona.ghosh@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center Otolaryngology Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults ≥18 years old undergoing awake otolaryngologic procedures in the outpatient clinic
• Able to provide informed consent

Exclusion Criteria:

• Hypersensitivity to fragrances
• Taking systemic NSAIDs or other systemic pain-relieving medications within 48 hours
• Taking anxiolytics, hypnotics, sedating antihistamines, antidepressants on regular basis within 4 weeks
• Pregnant or breastfeeding
• Participation in another clinical research study within the prior 30 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lavender Aromatherapy; 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	Other: Lavender Aromatherapy; Lavender essential oil on cotton ball, and in aromatherapy diffuser
Placebo Comparator: Placebo; 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	Other: Placebo Aromatherapy; Saline on cotton ball and in aromatherapy diffuser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	Immediately after the procedure

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Ankona Ghosh, MD, Cedars-Sinai Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 9, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Otolaryngology; Aromatherapy; Awake procedure
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Thyroid Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Nose Diseases; Otorhinolaryngologic Diseases; Thyroid Diseases; Rhinitis; Thyroid Nodule; Rhinitis, Vasomotor
• Other Study ID Numbers: STUDY00004415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No