## Protocol Section
### Identification Module
**NCT ID:** NCT06400979

**Brief Title:** 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

#### Organization Study ID Info
**ID:** UCaliforniaDavis
#### Organization
**Class:** OTHER
**Full Name:** University of California, Davis
### Status Module
#### Completion Date
**Date:** 2022-05-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-06

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-05-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-06
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-06
**Study First Submit QC Date:** 2024-05-01
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Beekley Medical

#### Lead Sponsor

**Class:** OTHER

**Name:** University of California, Davis

#### Responsible Party

**Investigator Affiliation:** University of California, Davis

**Investigator Full Name:** Carolyn Mendoza Mofidi

**Investigator Title:** Assistant Nurse Manager

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Effectiveness of Aromatherapy

**Keywords:**

- aromatherapy

- acute care unit

- medical surgical unit

- inhaled aromatherapy

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Interventional aromatherapy tab used to deliver inhaled aromatherapy to participants

**Intervention Names:**

- Device: Elequil aromatab

**Label:** Aromatherapy aromatab

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Aromatherapy aromatab

**Description:** Aromatherapy impregnated tab utilized to dispense inhaled scent for the study

**Name:** Elequil aromatab

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The use of a pre and post test to evaluate baseline and post data using 0-10 Numeric Scale where 0 is the best and 10 is the worst.

**Measure:** Aromatherapy is hypothesized to be effective in decreasing pain in the hospitalized patient.

**Time Frame:** 8 hours

**Description:** The use of a pre and post test to evaluate baseline and post data using 0-5 Likert scales where 0 is the best and 5 is the worst.

**Measure:** Aromatherapy is hypothesized to be effective in decreasing nausea in the hospitalized patient.

**Time Frame:** 8 hours

**Description:** The use of a pre and post test to evaluate baseline and post data using 0-5 Likert scale where 0 is the best and 5 is the worst.

**Measure:** Aromatherapy is hypothesized to be effective in decreasing anxiety in the hospitalized patient.

**Time Frame:** 8 hours

#### Secondary Outcomes

**Description:** The use of a posttest to evaluate effectiveness using a yes or no response.

**Measure:** Aromatherapy is hypothesized to increase satisfaction in the hospitalized patient

**Time Frame:** 8 hours

**Description:** The use of a posttest to evaluate effectiveness using a yes or no response.

**Measure:** Aromatherapy is hypothesized to increase well-being in the hospitalized patient

**Time Frame:** 8 hours

**Description:** The use of a posttest to evaluate effectiveness using a yes or no response.

**Measure:** Aromatherapy is hypothesized to increase sleep in the hospitalized patient

**Time Frame:** 8 hours

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Sacramento

**Country:** United States

**Facility:** UC Davis Medical Center

**State:** California

**Zip:** 95817

### IPD Sharing Statement Module

**Description:** We will not be sharing subject data after the conclusion of the study

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

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

**PMID:** 11342402

**Citation:** 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

**Citation:** 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

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

**PMID:** 10962794

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

#### See Also Links

**Label:** Instructional video on how to use aromatab

**URL:** https://vimeo.com/276457486

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12273

- Name: Nausea

- Relevance: HIGH

- As Found: Nausea

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009325

- Term: Nausea

### Misc Info Module

- Version Holder: 2024-05-24
