Inferior Turbinate Hypertrophy, Chronic Rhinosinusitis (CRS), Rhinitis, Vasomotor, Thyroid Nodules, Vocal Fold Immobility
Conditions
Keywords
Aromatherapy, Otolaryngology, Awake procedure
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
Interventions
Lavender essential oil on cotton ball, and in aromatherapy diffuser
OTHERPlacebo Aromatherapy
Saline on cotton ball and in aromatherapy diffuser
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in visual analog scale anxiety, measured on a 10 cm scale | 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 | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Impressions of Lavender Aromatherapy, measured on Likert scale and in Yes/No format in post-procedural questionnaire | Immediately after the procedure | 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) |
Countries
United States
Contacts
Primary ContactDhruv S Kothari, MD
Backup ContactAnkona Ghosh, MD
Outcome results
None listed