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Aromatherapy for Management of Pain, Anxiety, and Nausea in the Acute Care Setting

Aromatherapy for Management of Pain, Anxiety, and Nausea in the Acute Care Setting

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06400979
Enrollment
94
Registered
2024-05-06
Start date
2020-12-01
Completion date
2022-05-01
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effectiveness of Aromatherapy

Keywords

aromatherapy, acute care unit, medical surgical unit, inhaled aromatherapy

Brief summary

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.

Detailed description

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.

Interventions

DEVICEElequil aromatab

Aromatherapy impregnated tab utilized to dispense inhaled scent for the study

Sponsors

University of California, Davis
Lead SponsorOTHER
Beekley Medical
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

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 0-5 nausea scale by Halpin et al. Aromatherapy (Elequil aromatabs) was administered for 8 hours. Sleep, satisfaction, well-being, and concurrent medication use were assessed post-aromatherapy.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age 18 years or older, * Admission to Tower 4 for an anticipated inpatient stay \>24 hours, * Alert and oriented, * Capable of using a visual scale to self-report symptoms, * Naïve to the use of aromatherapy for the use of decreasing pain, anxiety and/or nausea to participate, * Not on a pediatric service.

Exclusion criteria

* Cognitively impaired, * Post-op from an otolaryngologic surgery (another study was being conducted concurrently with this patient population and we did not want to interfere with those results), * Known impaired olfactory function (limited or no sense of smell), * On any psychiatric holds (e.g., 5150's), * Known allergies to essential oils, * Sensitive or allergic to plants (specifically to lavender plants, orange blossoms, sandalwood trees, or peppermint leaves) as essential oils are natural aromas derived from plants, * Active participant of another Research Protocol, * Admitted as a "short stay" or on "observation" status, * Have a known history of Atrial Fibrillation. The use of peppermint has known effects on stimulating atrial fibrillation, * Is a prisoner, * Known pregnancy, or * Expected to be transferred out of Tower 4 and/or discharged from the hospital within twenty-four hours.

Design outcomes

Primary

MeasureTime frameDescription
Numerical Rating Pain ScalePre-Post Aromatherapy Administration (8 hours)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.
Nausea ScalePre-Post Aromatherapy Administration (8 hours)Nausea Scale: 0-5 Nausea Scale. 0 - No nausea and 5 - severe nausea
Anxiety Likert ScalePre-Post Aromatherapy Admin (8 hours)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).

Secondary

MeasureTime frameDescription
Patient Satisfaction8 hoursThe use of a post-survey to evaluate effectiveness of aromatherapy on patient satisfaction using a yes or no response.
Well-being8 hoursThe use of a post-survey to evaluate effectiveness of aromatherapy on the subject's well-being using a yes or no response.
Increased Sleep8 hoursThe use of a post-survey to evaluate effectiveness of aromatherapy in increasing sleep using a yes or no response.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

Ninety-four subjects of the intended one hundred were enrolled and consented. Sixty-four completed the study in its entirety, with both pre- and post-surveys being administered. Reasons for not having a post-survey completed: lack of communication of when the post- survey should be given, patient was asleep, no investigator working to administer the post-test, or the post-test was simply forgotten. One participant did not complete the study because it was stated that the scent was too strong.

Participants by arm

ArmCount
Aromatherapy Aromatab
Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants Use of an Elequil aromatab which is an aromatherapy impregnated tab utilized to dispense inhaled scent for the study. Each tab is impregnated with a specific essential oil that corresponds to either pain, anxiety or nausea.
94
Total94

Baseline characteristics

CharacteristicAromatherapy Aromatab
Age, Customized
Age of Participant
>18 to 65
80 Participants
Age, Customized
Age of Participant
>65
14 Participants
Sex/Gender, Customized
Female
59 participants
Sex/Gender, Customized
Male
35 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 94
other
Total, other adverse events
0 / 94
serious
Total, serious adverse events
0 / 94

Outcome results

Primary

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)

Population: Number of subjects utilizing aromatherapy to decrease anxiety.

ArmMeasureGroupValue (MEAN)Dispersion
Aromatherapy AromatabAnxiety Likert ScalePre-score for subjects utilizing aromatherapy to decrease anxiety2.6 score on a scaleStandard Deviation 1.9
Aromatherapy AromatabAnxiety Likert ScalePost-score for subjects utilizing aromatherapy for symptom management for anxiety1.8 score on a scaleStandard Deviation 1.6
p-value: <0.0001ANCOVA
Primary

Nausea Scale

Nausea Scale: 0-5 Nausea Scale. 0 - No nausea and 5 - severe nausea

Time frame: Pre-Post Aromatherapy Administration (8 hours)

Population: Total number of subjects participating in the study

ArmMeasureGroupValue (MEAN)Dispersion
Aromatherapy AromatabNausea ScalePre-score for subjects utilizing aromatherapy to decrease nausea1.5 score on a scaleStandard Deviation 1.7
Aromatherapy AromatabNausea ScalePost-score for subjects utilizing aromatherapy for symptom management for nausea1.2 score on a scaleStandard Deviation 1.6
p-value: 0.13ANCOVA
Primary

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)

Population: Number of subjects utilizing aromatherapy tabs to decrease pain

ArmMeasureGroupValue (MEAN)Dispersion
Aromatherapy AromatabNumerical Rating Pain ScalePre-score for subjects utilizing Aromatherapy for pain5.7 score on a scaleStandard Deviation 3
Aromatherapy AromatabNumerical Rating Pain ScalePost-score for subjects utilizing Aromatherapy for symptom management for pain5.3 score on a scaleStandard Deviation 2.9
Aromatherapy AromatabNumerical Rating Pain ScalePain: Post vs Pre-1 score on a scaleStandard Deviation 2.9
p-value: 0.008ANCOVA
Secondary

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

Population: Number of subjects utilizing aromatherapy to measure its effectiveness on sleep

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Aromatherapy AromatabIncreased SleepNumber of subjects utilizing aromatherapy to measure its effectiveness on increasing sleep.55 Participants
Aromatherapy AromatabIncreased SleepNumber of subjects utilizing aromatherapy resulting in a decrease in sleep.10 Participants
Aromatherapy AromatabIncreased SleepNumber of unknown responses.29 Participants
p-value: 0.02ANCOVA
Secondary

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

Population: Number of subjects utilizing aromatherapy to measure its effectiveness on patient satisfaction.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Aromatherapy AromatabPatient SatisfactionNumber of subjects utilizing aromatherapy resulting in an increase in patient satisfaction47 Participants
Aromatherapy AromatabPatient SatisfactionNumber of subjects utilizing aromatherapy resulting in a decrease in patient satisfaction17 Participants
Aromatherapy AromatabPatient SatisfactionNumber of unknown responses30 Participants
p-value: 0.02t-test, 2 sided
Secondary

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

Population: Number of subjects utilizing aromatherapy to measure its effectiveness on the subject's well-being.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Aromatherapy AromatabWell-beingNumber of subjects utilizing aromatherapy resulting in an increase in patient well-being50 Participants
Aromatherapy AromatabWell-beingNumber of subjects utilizing aromatherapy resulting in a decrease in patient well-being19 Participants
Aromatherapy AromatabWell-beingNumber of unknown responses25 Participants
p-value: 0.02ANCOVA

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026