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

NCT04840212 | Completed

• 1 other identifier: STU-2020-1176
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• 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.

  72 hours after surgery

Secondary Outcomes (1)

• Mean duration of hospital stay

  6 months

Study Arms (2)

Study Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Lavender-Sandalwood scented aromatherapy sticker OTHER

The Lavender-Sandalwood scented aromatherapy sticker will be placed on the patient gown.

Study Group

Eligibility Criteria

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

You may qualify if:

• 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:

You may not qualify if:

• 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:

Sponsors & Collaborators

• Parkland Health and Hospital System: lead

Study Sites (1)

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Justin Buchert, MSN, M.Ed., MS, RN

  Parkland Health and Hospital System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Quality Specialist

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 9, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 15, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)