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NCT05660486 Clinical Trial

Aromatherapy Effect on Anxiety Prior to Ultrasound Guided Musculoskeletal Procedures

Anxiety State Clinical Trial

Official title:
The Effects of Aromatherapy on Anxiety Prior to Ultrasound Guided Musculoskeletal Procedures: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05660486
Other study ID # 20220850
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 31, 2024
Est. completion date July 1, 2025

Study information
Verified date May 2024
Source University of Miami
Contact Jonathan Presley, MD
Phone 305 585 9600
Email jrp184@med.miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to evaluate the effect of lavender essential oil on pre-procedure anxiety for patients undergoing ultrasound guided musculoskeletal procedures

Recruitment information / eligibility
Status Recruiting
Enrollment 48
Est. completion date July 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion criteria: Adults ages 18-85. Those undergoing ultrasound guided musculoskeletal procedures including joint, tendon, bursa, or periarticular structure injection/ aspiration. Proficient with English. Exclusion criteria: Patients currently on benzodiazepine anxiolytic therapy Those with significantly impaired sense of smell Allergy/aversion to lavender essential oils Patients with asthma Patients with history of migraines Patients with any other condition that, in the opinion of the investigator, would compromise the well-being of the patient or prevent the patient from meeting or performing study requirements Adults unable to consent Individuals who are not yet adults Pregnant women Prisoners

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Aromatherapy
Participants in this group will receive 2-3 drops of 100% pure Lavandula angustifolia essential oil applied to a surgical mask pre-procedure for aromatherapy.
• Placebo
Participants in this group will receive 2-3 drops of water applied to a surgical mask pre-procedure.

Locations
Country Name City State
United States University of Miami Hospital Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anxiety state as measured by VASA The Visual Analogue Scale for Anxiety (VASA) has scales ranging from 0 indicating "no anxiety" to 10 indicating "high anxiety" Up to 10 minutes after aromatherapy administration
Secondary Number of participants with an aborted ultrasound guided procedure Number of participants with an aborted ultrasound guided procedure due to intolerance Up to 60 minutes post aromatherapy administration
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