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

NCT06400979 | Completed Results FDA Device

• 1 other identifier: 1636824
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Effectiveness of Aromatherapy

Keywords

aromatherapy; acute care unit; medical surgical unit; inhaled aromatherapy

Outcome Measures

Primary Outcomes (3)

• 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.

  Pre-Post Aromatherapy Administration (8 hours)

• Nausea Scale

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

  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).

  Pre-Post Aromatherapy Admin (8 hours)

Secondary Outcomes (3)

• Patient Satisfaction

  8 hours

• Well-being

  8 hours

• Increased Sleep

  8 hours

Study Arms (1)

Aromatherapy aromatab

EXPERIMENTAL

Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants

Device: Elequil aromatab

Interventions

Elequil aromatab DEVICE

Aromatherapy impregnated tab utilized to dispense inhaled scent for the study

Aromatherapy aromatab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• Beekley Medical: collaborator

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (16)

• Frosch PJ, Johansen JD, Menne T, Pirker C, Rastogi SC, Andersen KE, Bruze M, Goossens A, Lepoittevin JP, White IR. Further important sensitizers in patients sensitive to fragrances. Contact Dermatitis. 2002 Nov;47(5):279-87. doi: 10.1034/j.1600-0536.2002.470204.x.

  PMID: 12534532 RESULT

• Bingham LJ, Tam MM, Palmer AM, Cahill JL, Nixon RL. Contact allergy and allergic contact dermatitis caused by lavender: A retrospective study from an Australian clinic. Contact Dermatitis. 2019 Jul;81(1):37-42. doi: 10.1111/cod.13247. Epub 2019 Apr 16.

  PMID: 30779160 RESULT

• Boehm K, Bussing A, Ostermann T. Aromatherapy as an adjuvant treatment in cancer care--a descriptive systematic review. Afr J Tradit Complement Altern Med. 2012 Jul 1;9(4):503-18. doi: 10.4314/ajtcam.v9i4.7. eCollection 2012.

  PMID: 23983386 RESULT

• Buckle J. The role of aromatherapy in nursing care. Nurs Clin North Am. 2001 Mar;36(1):57-72.

  PMID: 11342402 RESULT

• Johnson JR, Rivard RL, Griffin KH, Kolste AK, Joswiak D, Kinney ME, Dusek JA. The effectiveness of nurse-delivered aromatherapy in an acute care setting. Complement Ther Med. 2016 Apr;25:164-9. doi: 10.1016/j.ctim.2016.03.006. Epub 2016 Mar 7.

  PMID: 27062964 RESULT

• Cho MY, Min ES, Hur MH, Lee MS. Effects of aromatherapy on the anxiety, vital signs, and sleep quality of percutaneous coronary intervention patients in intensive care units. Evid Based Complement Alternat Med. 2013;2013:381381. doi: 10.1155/2013/381381. Epub 2013 Feb 17.

  PMID: 23476690 RESULT

• Cooke B, Ernst E. Aromatherapy: a systematic review. Br J Gen Pract. 2000 Jun;50(455):493-6.

  PMID: 10962794 RESULT

• Halpin A, Huckabay LM, Kozuki JL, Forsythe D. Weigh the benefits of using a 0-to-5 nausea scale. Nursing. 2010 Nov;40(11):18-20. doi: 10.1097/01.NURSE.0000389030.33760.7a. No abstract available.

  PMID: 20975423 RESULT

• Lakhan SE, Sheafer H, Tepper D. The Effectiveness of Aromatherapy in Reducing Pain: A Systematic Review and Meta-Analysis. Pain Res Treat. 2016;2016:8158693. doi: 10.1155/2016/8158693. Epub 2016 Dec 14.

  PMID: 28070420 RESULT

• Lis-Balchin M. Essential oils and 'aromatherapy': their modern role in healing. J R Soc Health. 1997 Oct;117(5):324-9. doi: 10.1177/146642409711700511.

  PMID: 9519666 RESULT

• Long L, Huntley A, Ernst E. Which complementary and alternative therapies benefit which conditions? A survey of the opinions of 223 professional organizations. Complement Ther Med. 2001 Sep;9(3):178-85. doi: 10.1054/ctim.2001.0453.

  PMID: 11926432 RESULT

• Maddocks-Jennings W, Wilkinson JM. Aromatherapy practice in nursing: literature review. J Adv Nurs. 2004 Oct;48(1):93-103. doi: 10.1111/j.1365-2648.2004.03172.x.

  PMID: 15347415 RESULT

• Moeini M, Khadibi M, Bekhradi R, Mahmoudian SA, Nazari F. Effect of aromatherapy on the quality of sleep in ischemic heart disease patients hospitalized in intensive care units of heart hospitals of the Isfahan University of Medical Sciences. Iran J Nurs Midwifery Res. 2010 Fall;15(4):234-9.

  PMID: 22049287 RESULT

• Quinlan-Colwell AD. Understanding the paradox of patient pain and patient satisfaction. J Holist Nurs. 2009 Sep;27(3):177-82; quiz 183-5. doi: 10.1177/0898010109332758. Epub 2009 Jul 8.

  PMID: 19587387 RESULT

• Shin BC, Lee MS. Effects of aromatherapy acupressure on hemiplegic shoulder pain and motor power in stroke patients: a pilot study. J Altern Complement Med. 2007 Mar;13(2):247-51. doi: 10.1089/acm.2006.6189.

  PMID: 17388768 RESULT

• Vickers A. Yes, but how do we know it's true? Knowledge claims in massage and aromatherapy. Complement Ther Nurs Midwifery. 1997 Jun;3(3):63-5. doi: 10.1016/s1353-6117(97)80035-2.

  PMID: 9439251 RESULT

Related Links

• Instructional video on how to use aromatab

Limitations and Caveats

Limitations included slow enrollment, study design and missing post-test scores. We had a slow start with enrolling subjects as many patients either did not fit the eligibility criteria, or they were not interested. In addition, with the COVID pandemic, it made it even more difficult to enroll patients. Finding our requisite number of subjects was more challenging than expected.

Results Point of Contact

• Title: Carolyn Mofidi, RN-BC, BSN, MS-L
• Organization: University of California, Davis Medical Center

cmofidi@ucdavis.edu

(916) 734-3333

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: May 6, 2024
• Study Start: December 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)