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Completed

NCT Number: NCT04396444

Lavender Aromasticks for Pain Control

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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Key information

Conditions

Pain Perception Behavior Health Behavior Patient Satisfaction Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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

    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.

Secondary outcomes

  1. Subjects' evaluation of the aromastick

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

    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.

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • dōTERRA International

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 20, 2020
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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