Clinical trial NCT04396444: Lavender Aromasticks for Pain Control
Official title: Lavender Aromasticks as an Option for Pain Control in the Vascular Surgery Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Perception
Patient Satisfaction
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: dōTERRA International
First posted: 2020-05-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoints for this study are patients' self-reported evaluations of the quality of pain management provided during their hospital stay.
timeFrame: Measured on day 6 of hospital stay or day of discharge; whichever is sooner
Secondary outcomes:
measure: Subjects' evaluation of the aromastick
timeFrame: Measured on day 6 of hospital stay or day of discharge; whichever is sooner
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State Health Milton S Hershey Medical Center
name: Rebecca Hornberger, MSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.