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| Name | Class |
|---|---|
| Beekley Medical | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aromatherapy aromatab | Experimental | Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elequil aromatab | Device | Aromatherapy impregnated tab utilized to dispense inhaled scent for the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | The use of a post-survey to evaluate effectiveness of aromatherapy on patient satisfaction using a yes or no response. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12534532 | Result | 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. | |
| 30779160 | 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. |
| Label | URL |
|---|---|
| Instructional video on how to use aromatab | View source |
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We will not be sharing subject data after the conclusion of the study
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Of the 94 consented subjects, 64 subjects completed the study in its entirety, with both pre- and post-surveys administered.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of subjects utilizing aromatherapy tabs to decrease pain | Posted | Mean | Standard Deviation | score on a scale | Pre-Post Aromatherapy Administration (8 hours) |
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Adverse event data was collected for the duration of patient enrollment in the study (8 hours during hospitalization).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aromatherapy Aromatab Used to Measure Effectiveness on Decreasing Pain | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased discomfort | General disorders | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Mofidi, RN-BC, BSN, MS-L | University of California, Davis Medical Center | (916) 734-3333 | cmofidi@ucdavis.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2020 | Oct 31, 2024 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 18, 2020 | Sep 24, 2024 | ICF_001.pdf |
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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.
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| 8 hours |
| Increased Sleep | The use of a post-survey to evaluate effectiveness of aromatherapy in increasing sleep using a yes or no response. | 8 hours |
| 23983386 | 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. |
| 11342402 | Result | Buckle J. The role of aromatherapy in nursing care. Nurs Clin North Am. 2001 Mar;36(1):57-72. |
| 27062964 | 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. |
| 23476690 | 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. |
| 10962794 | Result | Cooke B, Ernst E. Aromatherapy: a systematic review. Br J Gen Pract. 2000 Jun;50(455):493-6. |
| 20975423 | 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. |
| 28070420 | 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. |
| 9519666 | 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. |
| 11926432 | 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. |
| 15347415 | 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. |
| 22049287 | 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. |
| 19587387 | 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. |
| 17388768 | 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. |
| 9439251 | 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. |
| Participants |
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| Sex/Gender, Customized | Number | participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Counts |
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| Participants |
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| Primary | Nausea Scale | Nausea Scale: 0-5 Nausea Scale. 0 - No nausea and 5 - severe nausea | Total number of subjects participating in the study | Posted | Mean | Standard Deviation | score on a scale | Pre-Post Aromatherapy Administration (8 hours) |
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| 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). | Number of subjects utilizing aromatherapy to decrease anxiety. | Posted | Mean | Standard Deviation | score on a scale | Pre-Post Aromatherapy Admin (8 hours) |
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| Secondary | Patient Satisfaction | The use of a post-survey to evaluate effectiveness of aromatherapy on patient satisfaction using a yes or no response. | Number of subjects utilizing aromatherapy to measure its effectiveness on patient satisfaction. | Posted | Count of Participants | Participants | 8 hours |
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| 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. | Number of subjects utilizing aromatherapy to measure its effectiveness on the subject's well-being. | Posted | Count of Participants | Participants | 8 hours |
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| Secondary | Increased Sleep | The use of a post-survey to evaluate effectiveness of aromatherapy in increasing sleep using a yes or no response. | Number of subjects utilizing aromatherapy to measure its effectiveness on sleep | Posted | Count of Participants | Participants | 8 hours |
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| 0 |
| 94 |
| 0 |
| 94 |
| 0 |
| 94 |
| Anaphylactic symptoms | Immune system disorders | Non-systematic Assessment |
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| Runny nose/ nasal congestion (sinus issues) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Red or bumpy skin (indurations) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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