Lavender Aromasticks for Pain Control

NCT ID: NCT04396444

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Perception Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

Aromastick

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Aromastick

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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dōTERRA International

INDUSTRY

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Hornberger

Clinical Nurse, Heart and Vascular Progressive Care Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca Hornberger, MSN

Role: PRINCIPAL_INVESTIGATOR

Penn State Health Milton S Hershey Medical Center

Locations

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Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20400379 (View on PubMed)

Other Identifiers

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STUDY00011852

Identifier Type: -

Identifier Source: org_study_id

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