Inferior Turbinate HypertrophyNCT07299474
Efficacy of Lavender Aromatherapy on Anxiety and Pain Reduction During Awake Otolaryngologic Procedures
A study testing Lavender Aromatherapy in people with Inferior Turbinate Hypertrophy and Chronic Rhinosinusitis (CRS), run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inferior Turbinate Hypertrophy, Chronic Rhinosinusitis (CRS), Rhinitis, Vasomotor
- What is being tested?
- Lavender Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years old undergoing awake otolaryngologic procedures in the outpatient clinic
- Able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars-Sinai Medical Center Otolaryngology Clinics
Los Angeles, California, 90048
About this study
Official title: 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?
Read more
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
- Inferior Turbinate Hypertrophy, Chronic Rhinosinusitis (CRS), Rhinitis, Vasomotor, Thyroid Nodules, Vocal Fold Immobility
- Being tested
- Lavender Aromatherapy, Placebo Aromatherapy
- Keywords
- Aromatherapy, Otolaryngology, Awake procedure
- Medical subject headings
- Rhinitis, Vasomotor, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender AromatherapyOther
Lavender essential oil on cotton ball, and in aromatherapy diffuser
Placebo AromatherapyOther
Saline on cotton ball and in aromatherapy diffuser
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo Aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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)
Measured: 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
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)
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Inferior Turbinate HypertrophyStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ankona Ghosh, Cedars-Sinai Medical Center
- Investigators
- Ankona Ghosh, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299474
- Sponsor's protocol ID
- STUDY00004415
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 19962101Kothari 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.
PubMed 37712305Grunebaum 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.
PubMed 21649812Wotman 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.
PubMed 29299520
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Lavender Aromatherapy on Anxiety and Pain Reduction During Awake Otolaryngologic Procedures
- ClinicalTrials.gov ID
- NCT07299474
- Acronym / sponsor ID
- STUDY00004415
- Conditions
- Inferior Turbinate Hypertrophy, Chronic Rhinosinusitis (CRS), Rhinitis, Vasomotor, Thyroid Nodules, Vocal Fold Immobility
- Keywords
- Aromatherapy, Otolaryngology, Awake procedure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lavender Aromatherapy | Experimental | Other: Lavender AromatherapyParticipants 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 | Other: Placebo AromatherapyParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥18 years old undergoing awake otolaryngologic procedures in the outpatient clinic
- Able to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender AromatherapyLavender essential oil on cotton ball, and in aromatherapy diffuser | Other | Lavender Aromatherapy |
| Placebo AromatherapySaline on cotton ball and in aromatherapy diffuser | Other | Placebo |
Primary outcome
Change in visual analog scale anxiety, measured on a 10 cm scale
Time frame: Baseline, Periprocedural and Immediately after the procedure
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.
Likert scale of pain, measured on a scale of 0-10
Time frame: Immediately after the procedure
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
Likert scale subjective improvement with pain, measured on scale of 1-5
Time frame: Immediately after the procedure
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)
1 secondary outcome
Subjective Impressions of Lavender Aromatherapy, measured on Likert scale and in Yes/No format in post-procedural questionnaire
Time frame: Immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 19962101Braden 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.
- Background: PubMed 37712305Kothari 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.
- Background: PubMed 21649812Grunebaum 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.
- Background: PubMed 29299520Wotman 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ankona Ghosh, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Aromatherapy in people with Inferior Turbinate Hypertrophy and Chronic Rhinosinusitis (CRS), run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dhruv S Kothari, MD (310-560-7331, dhruv.kothari@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual analog scale anxiety, measured on a 10 cm scale (time frame: Baseline, Periprocedural and Immediately after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07299474, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.