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The Effectiveness of Aromatherapy in an Urban, Safety-Net Hospital on Pain

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ClinicalTrials.gov Identifier: NCT04840212
Recruitment Status : Not yet recruiting
First Posted : April 9, 2021
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Justin Buchert, Parkland Health and Hospital System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Management Other: Lavender-Sandalwood scented aromatherapy sticker Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effectiveness of Aromatherapy in an Urban, Safety-Net Hospital on Pain
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study 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 Lavender-Sandalwood scented aromatherapy sticker will be placed on the patient gown.

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. Number of participants who needed opioid pain medication administration after surgery [ Time Frame: 72 hours 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.


Secondary Outcome Measures :
  1. Mean duration of hospital stay [ Time Frame: 6 months ]
    Duration of hospital stay will be collected from the electronic medical record.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A) For the current study group:

  • Inpatients, 18 years and older, admitted to a surgical service inpatient unit and who are experiencing pain and/or anxiety, and
  • No history of chronic pain, respiratory problems, asthmas, allergies, or lost sense of smell, and
  • Provide informed consent to participate in the study, and
  • Complain of pain and anxiety in the 72 hours after surgery or intervention and requiring PANX.

B) For the historical control group:

• Patients from the same time in the previous year with the same inclusion and exclusion criteria.

Exclusion Criteria:

A) For the current study group:

  • Patients with known allergies or sensitivities to aromatherapy products.
  • Lack of interest in participating in or subsequent withdrawal from the research.
  • Patients who are intubated, have died, or had serious disease complications will also be excluded from the study time period and previous year historical control group.

Subject withdrawal from the Study

  • Patients who develop allergic symptoms while the aromatherapy patch is applied.
  • Patients who require intubation or critical interventions during their hospitalization.

B) For the historical control group:

• Anyone who does not meet the inclusion criteria


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04840212


Contacts
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Contact: Justin Buchert, MSN, M.Ed., MS, RN 469-419-3744 justin.buchert@phhs.org

Sponsors and Collaborators
Parkland Health and Hospital System
Investigators
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Principal Investigator: Justin Buchert, MSN, M.Ed., MS, RN Parkland Health and Hospital System
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Responsible Party: Justin Buchert, Quality Specialist, Parkland Health and Hospital System
ClinicalTrials.gov Identifier: NCT04840212    
Other Study ID Numbers: STU-2020-1176
First Posted: April 9, 2021    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No