Lavender Aromasticks for Pain Control

NCT04396444 | Completed DMC

• 1 other identifier: STUDY00011852
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Perception; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subjects' evaluation of the aromastick

  Measured on day 6 of hospital stay or day of discharge; whichever is sooner

Study Arms (2)

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.

Combination Product: Aromastick

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.

Combination Product: Aromastick

Interventions

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.

Blank Aromastick Group; Lavender Aromastick Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects 18 and over admitted to the vascular surgery service line on the Heart and Vascular Progressive Care Unit (HVPCU)
• Not cognitively impaired
• Able to perform teach-back of the education regarding safe use of the aromastick
• 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
• English is the primary language, as identified by the Adult Admission II Form

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• dōTERRA International: collaborator

Study Sites (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

• 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.

  PMID: 20400379 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Rebecca Hornberger, MSN

  Penn State Health Milton S Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse, Heart and Vascular Progressive Care Unit

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 20, 2020
• Study Start: August 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)