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| Name | Class |
|---|---|
| dōTERRA International | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lavender Aromastick Group | Experimental | 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. |
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| Blank Aromastick Group | Placebo Comparator | A study team member will prepare the blank aromastick by placing a blank cotton wick inside the aromastick tube and sealing the cap. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromastick | Combination Product | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Hornberger, MSN | Penn State Health Milton S Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20400379 | Background | 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. |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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