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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to immediately prior to procedure for reporting.

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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