An interventional study of Lavender-Sandalwood scented aromatherapy sticker in Pain Management, sponsored by Parkland Health and Hospital System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by Parkland Health and Hospital System · Not applicable, Interventional, and Supportive care
The purpose of this project is to evaluate the effectiveness of aromatherapy on reducing pain in the acute care setting at Parkland Health and Hospital System. The target population for this study will be patients who are recovering from surgical procedures and are in the Surgical Services inpatient units.
This study will evaluate the impact of aromatherapy on the administration of opioid pain medication administration among the inpatient Surgical Services population. Patients from multiple units (burns, trauma, plastics, general surgery, and orthopedics) will be included. The study duration will be six months.
The Lavender-Sandalwood scented aromatherapy sticker has been selected for this study because it helps promote relaxation, comfort, and sleep. After introducing the patient to the study and obtaining informed consent for participation, the sticker will be placed on the patient gown. The sticker aroma last for twelve (12) hours and can be replaced upon patient request. The sticker will be used for 72 hours after the surgical procedure and initiated during patient's hospital stay. After use of aromatherapy sticker, the patient will participate in a survey to evaluate their experience with the sticker. In addition, opioid pain medication administration will be collected along with demographic and relevant clinical information.
The historical control group will be comprised of hospitalized patients from the previous year with the dame time period, demographic characteristics, service line, and relevant clinical information. Other methods for establishing a control group (a randomized controlled trial or concurrent case control study) are not feasible due to the potential impact of the aromatherapy on all patients in close proximity to the enrolled patient. The historical control cohort will also allow to collect non-COVID time period data to avoid any bias due to the pandemic.
The primary endpoint for this study is a decrease in the percentage of study patients who are in the pain scale threshold from 7-10 requiring opioid pain medication administration 72 hours after surgery/intervention. The pain score will be recorded for each patient before opioid pain medication administration within the time period. The historical control group will be from the same precious year time frame to control for any seasonal bias. The first dose or baseline pain score will be collected for each group and other relevant pain scores within the 72-hour time period after surgery. Demographic and other clinically relevant information will be compared between study and historical control group to account for any differences in the primary and secondary outcomes.
Outcomes will be collected from the electronic medical record (pain scores, opioid pain medication administration, and length of stay by service line. Qualitative measures of aromatherapy effectiveness will be obtained through patient surveys.
Data to be extracted for the active current group and the historical matched control group include the following:
Patient demographics (matching variable list)
Other demographic variables not proposed in matching
Clinical history
Data to be extracted for the current active group:
Parkland Health and Hospital System is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
A) For the current study group:
B) For the historical control group:
Exclusion Criteria:
A) For the current study group:
Subject withdrawal from the Study
B) For the historical control group:
Patients currently hospitalized in multiple service lines (surgical intensive care unite \[SICU\], surgical progressive care unit \[SPCU\], burns, trauma, plastics, general surgery, orthopedics, surgical specialties, and inpatient rehabilitation) will be included. Lavender-Sandalwood scented aromatherapy sticker will be used throughout the patient hospital stay.
Other: Lavender-Sandalwood scented aromatherapy sticker
The historical control group will be comprised of hospitalized patients in multiple service lines from the previous year with the same time period, demographic characteristics, service line, and relevant clinical information.
The Lavender-Sandalwood scented aromatherapy sticker will be placed on the patient gown.
Number of participants who needed opioid pain medication administration after surgery
Pain scale is measured by patients verbal report of pain and ranges from 0 to 10 , with higher scores indicating more pain and thus a worse outcome.
Time frame: 72 hours after surgery
Mean duration of hospital stay
Duration of hospital stay will be collected from the electronic medical record.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Parkland Health and Hospital System