Aromatherapy Effect on Anxiety Prior to Ultrasound Guided Musculoskeletal Procedures

Study Overview
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Brief Summary
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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

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

Conditions
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Anxiety State

Intervention / Treatment
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* Other: Aromatherapy
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aromatherapy group<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo group<br>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<br>* Participants in this group will receive 2-3 drops of water applied to a surgical mask pre-procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |