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

NCT ID: NCT07299474

Last Updated: 2025-12-23

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

RECRUITING

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-01-31

Brief Summary

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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:

* 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

Detailed Description

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Conditions

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

Keywords

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Aromatherapy Otolaryngology Awake procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Lavender Aromatherapy

Intervention Type OTHER

Lavender essential oil on cotton ball, and in aromatherapy diffuser

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

Group Type PLACEBO_COMPARATOR

Placebo Aromatherapy

Intervention Type OTHER

Saline on cotton ball and in aromatherapy diffuser

Interventions

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Lavender Aromatherapy

Lavender essential oil on cotton ball, and in aromatherapy diffuser

Intervention Type OTHER

Placebo Aromatherapy

Saline on cotton ball and in aromatherapy diffuser

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ankona Ghosh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ankona Ghosh, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center Otolaryngology Clinics

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dhruv S Kothari, MD

Role: CONTACT

Phone: 310-560-7331

Email: [email protected]

Ankona Ghosh, MD

Role: CONTACT

Phone: 213-300-7972

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 19962101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37712305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21649812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29299520 (View on PubMed)

Other Identifiers

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STUDY00004415

Identifier Type: -

Identifier Source: org_study_id