Aromatherapy Effect on Anxiety Prior to Ultrasound Guided Musculoskeletal Procedures

NCT05660486 | Completed

• 1 other identifier: 20220850
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Anxiety State

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with an aborted ultrasound guided procedure

  Up to 60 minutes post aromatherapy administration

Study Arms (2)

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.

Other: Aromatherapy

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.

Other: Placebo

Interventions

Aromatherapy OTHER

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.

Aromatherapy group

Placebo OTHER

Participants in this group will receive 2-3 drops of water applied to a surgical mask pre-procedure.

Placebo group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Hospital

Miami, Florida, 33156, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tricia Prince, DO

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of clinical

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: January 31, 2024
• Primary Completion: November 14, 2025
• Study Completion: November 14, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)