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

NCT07299474 | Recruiting

• 1 other identifier: STUDY00004415
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyroid Nodules; Vocal Fold Immobility; Inferior Turbinate Hypertrophy; Chronic Rhinosinusitis (CRS); Rhinitis, Vasomotor

Keywords

Aromatherapy; Otolaryngology; Awake procedure

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Subjective Impressions of Lavender Aromatherapy, measured on Likert scale and in Yes/No format in post-procedural questionnaire

  Immediately after the procedure

Study Arms (2)

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

Other: Lavender Aromatherapy

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

Other: Placebo Aromatherapy

Interventions

Lavender Aromatherapy OTHER

Lavender essential oil on cotton ball, and in aromatherapy diffuser

Lavender Aromatherapy

Placebo Aromatherapy OTHER

Saline on cotton ball and in aromatherapy diffuser

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center Otolaryngology Clinics

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 19962101 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.

  PMID: 37712305 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.

  PMID: 21649812 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.

  PMID: 29299520 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Vasomotor; Thyroid Nodule

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Ankona Ghosh, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dhruv S Kothari, MD

CONTACT

310-560-7331; dhruv.kothari@cshs.org

Ankona Ghosh, MD

CONTACT

213-300-7972; ankona.ghosh@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 23, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)