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Aromatherapy for Pre-Procedure Anxiety
N/A
Recruiting
Led By Chane Price, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 minutes post aromatherapy administration
Summary
This trial studies if lavender oil can reduce pre-op anxiety for people getting spine procedures.
Who is the study for?
This trial is for English-speaking adults scheduled for certain pain relief procedures like medial branch blocks or epidural injections. It's not open to those who can't consent, have a poor sense of smell, dislike or are allergic to lavender, suffer from migraines, asthma, have anxiety disorders on treatment, are pregnant women, prisoners or minors.
What is being tested?
The study aims to see if smelling lavender oil before ultrasound-guided musculoskeletal procedures can help reduce anxiety compared to a placebo (a substance with no therapeutic effect).
What are the potential side effects?
While aromatherapy is generally considered safe, some may experience headaches or allergic reactions from the lavender essential oil used in this trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 minutes post aromatherapy administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 minutes post aromatherapy administration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anxiety state as measured by VASA
Secondary study objectives
Number of participants with an aborted ultrasound guided procedure
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Aromatherapy groupExperimental Treatment1 Intervention
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.
Group II: Placebo groupPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
955 Previous Clinical Trials
428,800 Total Patients Enrolled
10 Trials studying Anxiety
8,447 Patients Enrolled for Anxiety
Chane Price, MDPrincipal InvestigatorUniversity of Miami
Tricia Prince, DOPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am receiving or have received a specific spine pain treatment.I have asthma.I am unable to give consent for medical procedures.I am between 18 and 85 years old.I have a history of migraines.I am having an ultrasound-guided procedure for a joint or soft tissue issue.I am under the age of 18.I am currently taking benzodiazepines for anxiety.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo group
- Group 2: Aromatherapy group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.