An interventional study of Elequil aromatab in Effectiveness of Aromatherapy, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by University of California, Davis · Not applicable, Interventional, and Supportive care
The purpose of this interventional study is to investigate the effects of aromatherapy on an acute care unit and whether it is effective in decreasing physical or emotional stressors that occur as a hospitalized patient. This study aimed to expand the limited literature on aromatherapy use in hospitalized adults and its effectiveness in decreasing pain, anxiety, and nausea. The hypothesis was that use of aromatherapy would decrease pain, anxiety and nausea in hospitalized adults and increase patient satisfaction. While there is anecdotal evidence of its efficacy, few studies exist evaluating its effectiveness within peer-reviewed journals, specifically on acute care medical surgical units.
The goal for the study was to collect a sample of one hundred adult patients admitted to an acute care medical surgical unit. A quasi-experimental study with a single-arm pre-/post-test design evaluated one-time use of inhaled aromatherapy on hospitalized adults on an acute care unit. Pre-test tools included a numeric pain rating scale, facial anxiety scale and Halpin's 0-5 nausea scale. Aromatherapy (Elequil aromatabs) was administered for 8 hours. Sleep, satisfaction, well-being, and concurrent medication use were assessed post-aromatherapy. Descriptive and inferential statistics were performed. These subjects had to be conscious, oriented, able to consent, and able to understand the purpose of the study. Exclusion criteria were otolaryngology free flap patients (as this was a study being conducted on an otolaryngology acute care unit and another study was occurring with this population), patients with known allergies to essential oils, those taking sleep medications, or who have an aroma/essential oil contraindication. The use of a pre and post survey was used to measure the effectiveness of aromatherapy on pain, anxiety, and nausea. A baseline assessment was made of these ailments via Qualtrix. Subjects chose the aromatherapy tab fragrance that best fit their chief complaint, which was placed on their gown. After eight hours, a post-application survey to assess pain, anxiety, nausea, sleep/relaxation, overall satisfaction, and overall wellbeing was administered via Qualtrix. A numeric pain scale from 0-10, a 0-5 Likert Anxiety scale and a 0-5 nausea scale were used to measure efficacy. Sleep, satisfaction, and wellbeing was assessed with yes/no. A chart review to determine any measurable benefits in the reduction of related medications while using aromatherapy was to be conducted once one hundred subjects were obtained. The period for this study was approximately fifteen months.
University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.
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Exclusion Criteria:
Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants
Device: Elequil aromatab
Aromatherapy impregnated tab utilized to dispense inhaled scent for the study
Numerical Rating Pain Scale
The Numerical Rating Pain Scale measures pain experienced right now based on a 11-point Likert scale with choices of 0 = no pain, 5 = Moderate pain, 10 = Worst possible pain.
Time frame: Pre-Post Aromatherapy Administration (8 hours)
Nausea Scale
Nausea Scale: 0-5 Nausea Scale. 0 - No nausea and 5 - severe nausea
Time frame: Pre-Post Aromatherapy Administration (8 hours)
Anxiety Likert Scale
This one-item scale consisted of five evenly spaced numbers each anchored to a level of anxiety (0 = not at all anxious, 2 = a little anxious, 3 = moderately anxious, 4 = very anxious, 5 = extremely anxious).
Time frame: Pre-Post Aromatherapy Admin (8 hours)
Patient Satisfaction
The use of a post-survey to evaluate effectiveness of aromatherapy on patient satisfaction using a yes or no response.
Time frame: 8 hours
Well-being
The use of a post-survey to evaluate effectiveness of aromatherapy on the subject's well-being using a yes or no response.
Time frame: 8 hours
Increased Sleep
The use of a post-survey to evaluate effectiveness of aromatherapy in increasing sleep using a yes or no response.
Time frame: 8 hours
The study took place from December 1, 2020 to May 1, 2022.This study aimed to collect a sample of one hundred adult patients admitted to an acute care medical surgical unit.
| Milestone | Aromatherapy Aromatab |
|---|---|
| Started | 94 |
| Completed | 64 |
| Not completed | 30 |
| Withdrew: Lost to follow-up | 29 |
| Withdrew: Withdrawal by subject | 1 |
The Numerical Rating Pain Scale measures pain experienced right now based on a 11-point Likert scale with choices of 0 = no pain, 5 = Moderate pain, 10 = Worst possible pain.
| score on a scale | Aromatherapy Aromatab |
|---|---|
| Pre-score for subjects utilizing Aromatherapy for pain | 5.7 ± 3.0 |
| Post-score for subjects utilizing Aromatherapy for symptom management for pain | 5.3 ± 2.9 |
| Pain: Post vs Pre | -1 ± 2.9 |
Nausea Scale: 0-5 Nausea Scale. 0 - No nausea and 5 - severe nausea
| score on a scale | Aromatherapy Aromatab |
|---|---|
| Pre-score for subjects utilizing aromatherapy to decrease nausea | 1.5 ± 1.7 |
| Post-score for subjects utilizing aromatherapy for symptom management for nausea | 1.2 ± 1.6 |
This one-item scale consisted of five evenly spaced numbers each anchored to a level of anxiety (0 = not at all anxious, 2 = a little anxious, 3 = moderately anxious, 4 = very anxious, 5 = extremely anxious).
| score on a scale | Aromatherapy Aromatab |
|---|---|
| Pre-score for subjects utilizing aromatherapy to decrease anxiety | 2.6 ± 1.9 |
| Post-score for subjects utilizing aromatherapy for symptom management for anxiety | 1.8 ± 1.6 |
The use of a post-survey to evaluate effectiveness of aromatherapy on patient satisfaction using a yes or no response.
| Participants | Aromatherapy Aromatab |
|---|---|
| Number of subjects utilizing aromatherapy resulting in an increase in patient satisfaction | 47 |
| Number of subjects utilizing aromatherapy resulting in a decrease in patient satisfaction | 17 |
| Number of unknown responses | 30 |
The use of a post-survey to evaluate effectiveness of aromatherapy on the subject's well-being using a yes or no response.
| Participants | Aromatherapy Aromatab |
|---|---|
| Number of subjects utilizing aromatherapy resulting in an increase in patient well-being | 50 |
| Number of subjects utilizing aromatherapy resulting in a decrease in patient well-being | 19 |
| Number of unknown responses | 25 |
The use of a post-survey to evaluate effectiveness of aromatherapy in increasing sleep using a yes or no response.
| Participants | Aromatherapy Aromatab |
|---|---|
| Number of subjects utilizing aromatherapy to measure its effectiveness on increasing sleep. | 55 |
| Number of subjects utilizing aromatherapy resulting in a decrease in sleep. | 10 |
| Number of unknown responses. | 29 |
Collected over Adverse event data was collected for the duration of patient enrollment in the study (8 hours during hospitalization).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aromatherapy Aromatab Used to Measure Effectiveness on Decreasing Pain | 0/94 (0%) | 0/94 (0%) | 0/94 (0%) |
| Event | Aromatherapy Aromatab Used to Measure Effectiveness on Decreasing Pain |
|---|---|
| Increased discomfortGeneral disorders | 0/94 |
| Anaphylactic symptomsImmune system disorders | 0/94 |
| Runny nose/ nasal congestion (sinus issues)Respiratory, thoracic and mediastinal disorders | 0/94 |
| DermatitisSkin and subcutaneous tissue disorders | 0/94 |
| RashSkin and subcutaneous tissue disorders | 0/94 |
| Red or bumpy skin (indurations)Skin and subcutaneous tissue disorders | 0/94 |
Of the 94 consented subjects, 64 subjects completed the study in its entirety, with both pre- and post-surveys administered.
| Age, Customized(Participants) | Aromatherapy Aromatab |
|---|---|
| Age of Participant — >18 to 65 | 80 |
| Age of Participant — >65 | 14 |
| Sex/Gender, Customized(participants) | Aromatherapy Aromatab |
|---|---|
| Female | 59 |
| Male | 35 |
| Race and Ethnicity Not Collected(Participants) | Aromatherapy Aromatab |
|---|
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Plan to share: No — We will not be sharing subject data after the conclusion of the study
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University of California, Davis