About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults ≥18 years old undergoing awake otolaryngologic procedures in the outpatient clinic
Able to provide informed consent
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Lavender Aromatherapy
Other interventionLavender essential oil on cotton ball, and in aromatherapy diffuser
Placebo Aromatherapy
Other interventionSaline on cotton ball and in aromatherapy diffuser
Treatment groups
Trial outcomes
Primary outcomes
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.
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
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)
Secondary outcomes
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)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.