Trial Outcomes & Findings for Aromatherapy for Management of Pain, Anxiety, and Nausea in the Acute Care Setting (NCT NCT06400979)

NCT ID: NCT06400979

Last Updated: 2025-04-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: Pre-Post Aromatherapy Administration (8 hours)
• Results posted on: 2025-04-18

Participant Flow

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.

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.

Participant milestones

Measure	Aromatherapy Aromatab Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants The study used an Elequil aromatab which is an aromatherapy impregnated tab utilized to dispense a specific inhaled scent for the study. Each aromatherapy tab was used to determine its effects on pain, nausea and anxiety.
Overall Study STARTED	94
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Measure	Aromatherapy Aromatab Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants The study used an Elequil aromatab which is an aromatherapy impregnated tab utilized to dispense a specific inhaled scent for the study. Each aromatherapy tab was used to determine its effects on pain, nausea and anxiety.
Overall Study Lost to Follow-up	29
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Aromatherapy Aromatab n=94 Participants 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.
Age, Customized Age of Participant · >18 to 65	80 Participants n=94 Participants
Age, Customized Age of Participant · >65	14 Participants n=94 Participants
Sex/Gender, Customized Female	59 participants n=94 Participants
Sex/Gender, Customized Male	35 participants n=94 Participants

PRIMARY outcome

Timeframe: Pre-Post Aromatherapy Administration (8 hours)

Population: Number of subjects utilizing aromatherapy tabs to decrease pain

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.

Outcome measures

Measure	Aromatherapy Aromatab n=94 Participants Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants Elequil aromatab: Aromatherapy impregnated tab utilized to dispense inhaled scent for the study to analyze the effectiveness in decreasing pain.
Numerical Rating Pain Scale Pre-score for subjects utilizing Aromatherapy for pain	5.7 score on a scale Standard Deviation 3.0
Numerical Rating Pain Scale Post-score for subjects utilizing Aromatherapy for symptom management for pain	5.3 score on a scale Standard Deviation 2.9
Numerical Rating Pain Scale Pain: Post vs Pre	-1 score on a scale Standard Deviation 2.9

PRIMARY outcome

Timeframe: Pre-Post Aromatherapy Administration (8 hours)

Population: Total number of subjects participating in the study

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

Outcome measures

Measure	Aromatherapy Aromatab n=94 Participants Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants Elequil aromatab: Aromatherapy impregnated tab utilized to dispense inhaled scent for the study to analyze the effectiveness in decreasing pain.
Nausea Scale Pre-score for subjects utilizing aromatherapy to decrease nausea	1.5 score on a scale Standard Deviation 1.7
Nausea Scale Post-score for subjects utilizing aromatherapy for symptom management for nausea	1.2 score on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: Pre-Post Aromatherapy Admin (8 hours)

Population: Number of subjects utilizing aromatherapy to decrease anxiety.

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).

Outcome measures

Measure	Aromatherapy Aromatab n=94 Participants Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants Elequil aromatab: Aromatherapy impregnated tab utilized to dispense inhaled scent for the study to analyze the effectiveness in decreasing pain.
Anxiety Likert Scale Pre-score for subjects utilizing aromatherapy to decrease anxiety	2.6 score on a scale Standard Deviation 1.9
Anxiety Likert Scale Post-score for subjects utilizing aromatherapy for symptom management for anxiety	1.8 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: 8 hours

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

The use of a post-survey to evaluate effectiveness of aromatherapy on patient satisfaction using a yes or no response.

Outcome measures

Measure	Aromatherapy Aromatab n=94 Participants Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants Elequil aromatab: Aromatherapy impregnated tab utilized to dispense inhaled scent for the study to analyze the effectiveness in decreasing pain.
Patient Satisfaction Number of subjects utilizing aromatherapy resulting in an increase in patient satisfaction	47 Participants
Patient Satisfaction Number of subjects utilizing aromatherapy resulting in a decrease in patient satisfaction	17 Participants
Patient Satisfaction Number of unknown responses	30 Participants

SECONDARY outcome

Timeframe: 8 hours

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

Outcome measures

Measure	Aromatherapy Aromatab n=94 Participants Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants Elequil aromatab: Aromatherapy impregnated tab utilized to dispense inhaled scent for the study to analyze the effectiveness in decreasing pain.
Well-being Number of subjects utilizing aromatherapy resulting in an increase in patient well-being	50 Participants
Well-being Number of subjects utilizing aromatherapy resulting in a decrease in patient well-being	19 Participants
Well-being Number of unknown responses	25 Participants

SECONDARY outcome

Timeframe: 8 hours

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

The use of a post-survey to evaluate effectiveness of aromatherapy in increasing sleep using a yes or no response.

Outcome measures

Measure	Aromatherapy Aromatab n=94 Participants Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants Elequil aromatab: Aromatherapy impregnated tab utilized to dispense inhaled scent for the study to analyze the effectiveness in decreasing pain.
Increased Sleep Number of subjects utilizing aromatherapy to measure its effectiveness on increasing sleep.	55 Participants
Increased Sleep Number of subjects utilizing aromatherapy resulting in a decrease in sleep.	10 Participants
Increased Sleep Number of unknown responses.	29 Participants

Adverse Events

Aromatherapy Aromatab Used to Measure Effectiveness on Decreasing Pain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aromatherapy Aromatab Used to Measure Effectiveness on Decreasing Pain n=94 participants at risk Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants Elequil aromatab: Aromatherapy impregnated tab utilized to dispense inhaled scent for the study to analyze the effectiveness in decreasing pain. No adverse effects were noted
General disorders Dermatitis	0.00% 0/94 • Adverse event data was collected for the duration of patient enrollment in the study (8 hours during hospitalization).
General disorders Runny nose/ nasal congestion (sinus issues)	0.00% 0/94 • Adverse event data was collected for the duration of patient enrollment in the study (8 hours during hospitalization).
General disorders Rash	0.00% 0/94 • Adverse event data was collected for the duration of patient enrollment in the study (8 hours during hospitalization).
General disorders Red or bumpy skin (indurations)	0.00% 0/94 • Adverse event data was collected for the duration of patient enrollment in the study (8 hours during hospitalization).
General disorders Increased discomfort	0.00% 0/94 • Adverse event data was collected for the duration of patient enrollment in the study (8 hours during hospitalization).
General disorders Anaphylactic symptoms	0.00% 0/94 • Adverse event data was collected for the duration of patient enrollment in the study (8 hours during hospitalization).

Other adverse events

Adverse event data not reported

Additional Information

Carolyn Mofidi, RN-BC, BSN, MS-L

University of California, Davis Medical Center

Phone: (916) 734-3333

Email: cmofidi@ucdavis.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place