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Lavender Aromatherapy for Anxiety (RELAX Trial)
N/A
Recruiting
Led By Megan Tarr, MD
Research Sponsored by Wake Forest University Health Sciences
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 post procedure up to 2 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if creating a relaxing environment using lavender aromatherapy, calming music, dim lighting, and modest positioning during bladder injections can reduce anxiety and pain in women with urge urinary incontin
Who is the study for?
This trial is for women with Urge urinary incontinence (UUI) who experience anxiety and pain during bladder chemodenervation procedures. Participants must be scheduled for the procedure at Atrium Health's clinic and willing to try a relaxing environment package or placebo before treatment.
What is being tested?
The study tests if a 'Relaxing Environment Package'—lavender aromatherapy, calming music, dim lighting—lowers anxiety and pain compared to a standard office setting during bladder chemodenervation. It's a randomized control trial where participants are assigned by chance to either the relaxing setup or placebo group.
What are the potential side effects?
Since this trial focuses on environmental factors rather than medication, there are no direct side effects from drugs being tested. However, individuals may have varying responses to sensory elements like lavender scent or music.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to immediately prior to procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to immediately prior to procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change in Visual Analog Scale (VAS) Anxiety Scores
Secondary study objectives
Patient satisfaction with their procedure experience Scores
Procedure Staff Burnout Scores - Burnout Battery visual analog scale for healthcare worker burnout
Visual Analog Scale (VAS) Pain during the chemodenervation procedure
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lavender aromatherapy stickerExperimental Treatment1 Intervention
Lavender aromatherapy sticker on patient Calming music from Sirius station 68 (Spa) playing via overhead speakers Overhead lights off, two lanterns lit to provide dim lighting Avoid stirrup use
Group II: Control - no InterventionActive Control1 Intervention
Non-aromatic (placebo) sticker on patient No music playing Overhead lights on Stirrups used
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,478,251 Total Patients Enrolled
Megan Tarr, MDPrincipal InvestigatorWake Forest University Health Sciences