Clinical trial NCT06400979: Aromatherapy for Management of Pain, Anxiety, and Nausea in the Acute Care Setting
Official title: Aromatherapy for Management of Pain, Anxiety, and Nausea in the Acute Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effectiveness of Aromatherapy
Keywords: aromatherapy
acute care unit
medical surgical unit
inhaled aromatherapy
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Beekley Medical
First posted: 2024-05-06
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numerical Rating Pain Scale
timeFrame: Pre-Post Aromatherapy Administration (8 hours)
measure: Nausea Scale
timeFrame: Pre-Post Aromatherapy Administration (8 hours)
measure: Anxiety Likert Scale
timeFrame: Pre-Post Aromatherapy Admin (8 hours)
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 8 hours
measure: Well-being
timeFrame: 8 hours
measure: Increased Sleep
timeFrame: 8 hours
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
References:
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