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Clinical Trials/NCT05660486
NCT05660486CompletedNot Applicable

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

University of Miami1 site in 1 country48 target enrollmentStarted: January 31, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
Anxiety state as measured by VASA

Study Overview

Brief 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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adults ages 18-
  • •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

Arms & Interventions

Aromatherapy group

Experimental

Participants in this group will receive, lavender essential oil applied to their surgical mask for 5 minutes prior to scheduled standard of care ultrasound guided musculoskeletal procedure.

Intervention: Aromatherapy (Other)

Placebo group

Placebo Comparator

Participants in this group will receive water applied to their surgical mask for 5 minutes prior to scheduled standard of care ultrasound guided musculoskeletal procedure.

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

Anxiety state as measured by VASA

Time Frame: Up to 10 minutes after aromatherapy administration

The Visual Analogue Scale for Anxiety (VASA) has scales ranging from 0 indicating "no anxiety" to 10 indicating "high anxiety"

Secondary Outcomes

  • Number of participants with an aborted ultrasound guided procedure(Up to 60 minutes post aromatherapy administration)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tricia Prince

Assistant Professor of clinical

University of Miami

Study Sites (1)

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