Lavender Aromasticks for Pain Control

Lavender Aromasticks as an Option for Pain Control in the Vascular Surgery Population

The purpose of this randomized pilot study is to collect preliminary data on the impacts of lavender essential oil aromatherapy on the patient-reported quality of pain management provided for the vascular surgery patient population. The investigators hypothesize that individuals who use a lavender aromastick as a part of their pain management plan will report improved perceptions of the quality of their pain management as measured by the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R).

Subjects will be randomized to the control (empty aromastick) and intervention group (aromastick infused with lavender oil), and will use this device as an addition to their pain management plan.

Additionally, this pilot study will allow the researchers to evaluate the feasibility of a larger randomized control trial, assess the validity of the survey tool, and collect feedback from patients on the acceptability of the aromatherapy intervention as a complementary therapy during their hospital stay.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction; Pain Perception
• Intervention / Treatment: Combination product: Aromastick

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects 18 and over admitted to the vascular surgery service line on the Heart and Vascular Progressive Care Unit (HVPCU)
2. Not cognitively impaired
3. Able to perform teach-back of the education regarding safe use of the aromastick
4. Able to demonstrate use of the Numeric Pain Rating Scale (NPRS), as evidenced by their ability to answer the initial NPRS question on the Adult Admission II Form used to admit all patients to the hospital
5. English is the primary language, as identified by the Adult Admission II Form

Exclusion Criteria:

1. Subjects who are unable to consent themselves
2. Subjects who cannot provide teach-back on the safe use of the aromastick
3. Subjects unable to use the NPRS to rate their pain
4. Research team member and/or bedside nurse assess that subject has a cognitive deficit that would prohibit safe use of the aromastick
5. Subjects on suicide precautions
6. Pregnant subjects
7. Prisoners
8. Individuals under age 18
9. Subjects with a current plan to use personal aromatherapy devices during their inpatient stay
10. Subjects with known lavender allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lavender Aromastick Group; The aromastick is a plastic tube, similar in size to a lipstick. A study team member will prepare the aromastick by infusing ten drops of lavender essential oil onto a blank cotton wick inside the tube and sealing the cap.	Combination product: Aromastick; Vascular surgery patients will be randomized to either the intervention group and receive a lavender infused aromastick to use as an adjunct to their inpatient pain management plan, or to the control group, given a blank aromastick. Subjects will be blinded to their group.
PLACEBO_COMPARATOR: Blank Aromastick Group; A study team member will prepare the blank aromastick by placing a blank cotton wick inside the aromastick tube and sealing the cap.	Combination product: Aromastick; Vascular surgery patients will be randomized to either the intervention group and receive a lavender infused aromastick to use as an adjunct to their inpatient pain management plan, or to the control group, given a blank aromastick. Subjects will be blinded to their group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoints for this study are patients' self-reported evaluations of the quality of pain management provided during their hospital stay.	Measured using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) survey tool. The APS-POQ-R has 18 primary questions with continuous rating scales from 0 - 10 or from 0% - 100%. This study, with permission from the original authors, uses a modified survey, with 10 questions evaluating the subject's pain levels and degree to which pain interferes with various aspects of their quality of life. In these questions, higher numbers indicate higher levels of pain and distress. Four additional Likert style questions evaluate subjects' satisfaction with pain management, with higher numbers indicating higher levels of satisfaction.	Measured on day 6 of hospital stay or day of discharge; whichever is sooner

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects' evaluation of the aromastick	Survey questions will also be asked about use of the aromastick to evaluate acceptability of the intervention device. These are yes/no questions, and questions measuring the frequency of device use.	Measured on day 6 of hospital stay or day of discharge; whichever is sooner

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: dōTERRA International
• Investigators: Principal Investigator: Rebecca Hornberger, MSN, Penn State Health Milton S. Hershey Medical Center

Publications and helpful links

General Publications

• Gordon DB, Polomano RC, Pellino TA, Turk DC, McCracken LM, Sherwood G, Paice JA, Wallace MS, Strassels SA, Farrar JT. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010 Nov;11(11):1172-86. doi: 10.1016/j.jpain.2010.02.012. Epub 2010 Apr 18.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2020
• Primary Completion (ACTUAL): October 31, 2021
• Study Completion (ACTUAL): October 31, 2021

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (ACTUAL): May 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00011852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No