Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder: RELAX Trial
Phase: NA
Conditions: Anxiety, Pain, Burnout, Professional
Sponsor: Wake Forest University Health Sciences

 
 
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Protocol version: 1.2 
Protocol Date: 5/1/24 
STUDY TITLE:  
 
 
Relaxing Environment to Lower Anxiety 
during Onabotulinum Toxin Chemodenervation 
of the Bladder: RELAX Trial 
 
 
NCT06319898 
 
Document Date: 05/01/2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Protocol Date: 5/1/24 
STUDY TITLE:  
Relaxing Environment to Lower Anxiety during Onabotulinum Toxin Chemodenervation of the Bladder: 
RELAX Trial 
 
Principal Investigator: 
Megan Tarr, MD 
Atrium Health 
Wake Forest University School of Medicine 
Megan.tarr@atriumhealth.org 
 
Co-investigator(s):   
Erin Franks, MD 
Atrium Health 
Wake Forest University School of Medicine 
Erin.franks@atriumhealth.org 
 
Michael Kennelly, MD 
Atrium Health 
Wake Forest University School of Medicine 
Michael.kennelly@atriumhealth.org 
 
Erinn Myers, MD 
Atrium Health 
Wake Forest University School of Medicine 
Erinn.myers@atriumhealth.org 
 
Zahra Bahrani-Mostafavi, PhD 
Atrium Health 
Wake Forest University School of Medicine 
Zahra.bahranimostafavi@atriumhealth.org 
 
Joseph Rigdon, PhD 
Wake Forest University School of Medicine 
Jrigdon@wakehealth.edu 
 
Kelley Kaczmarski, RN, BSN 
Atrium Health 
Wake Forest University School of Medicine 
Kelley.kaczemarski@atriumhealth.org 
 
Sponsor or funding source: Departmental 
 
BACKGROUND 
Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients 
with refractory overactive bladder (OAB) or urgency urinary incontinence (UUI)1.  It is often performed 
as an office-based procedure under local anesthesia.  Alternatively, it can be performed in the operating 
room under general anesthesia.  The ability to receive intra-detrusor chemodenervation in the office 
allows patients to avoid the risks associated with general anesthesia and is significantly more cost 
effective2.  The procedure, however, is painful and can be anxiety provoking for patients; especially given 
that patients typically return every six to nine months for repeat injections1,2.   

 
 
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Relaxation and distraction techniques are one way to ease patients’ anxiety before an office-based 
procedure.  Aromatherapy and music have been shown to reduce anxiety and pain during procedures such 
as intravenous line placement, bone marrow biopsy, and cystoscopy3-7.  In the urogynecologic population, 
both lavender aromatherapy and listening to music during multi-channel urodynamics decreased patient 
anxiety and improved satisfaction8-9.  There have not, however, been any studies evaluating the use of 
aromatherapy or music during intra-detrusor chemodenervation procedures.   
 
While we do not know exactly how anxiety provoking office bladder chemodenervation is for patients, 
we do know that anxiety disorders are highly prevalent in women with overactive bladder as a 
population10.  One study of 274 women with OAB found that 62.4% had moderate to severe anxiety10.  
Addressing pre-procedural anxiety is important so patients will continue to pursue treatment of their 
OAB/UUI in the outpatient environment.  Achieving a relaxing office environment with simple 
adjustments to aroma, music, and lighting may be one way to help patients feel less anxious, reduce the 
perception of procedural pain, and increase satisfaction with their procedural experience.    
 
STUDY PURPOSE 
This study aims to investigate whether women with OAB/UUI who receive office intra-detrusor 
chemodenervation injections performed in a relaxing environment of lavender aromatherapy, calming 
music, dim lighting, and modest positioning (Relaxing Environment Package) will have decreased 
anxiety and pain as well as increased post-procedure satisfaction compared to patients who receive 
chemodenervation in a typical office environment.  We will also investigate whether exposure to the 
relaxing environment impacts the well-being of staff involved in these procedures.  
 
STUDY OBJECTIVES 
Primary Objective  
Determine if women with OAB/UUI exposed to a Relaxing Environment Package during office 
administration of intra-detrusor onabotulinum toxin A injections have decreased pre-procedure anxiety 
based on a visual analog scale compared to women receiving intra-detrusor onabotulinum toxin A 
injections performed in a typical office setting. 
 
Secondary Objectives 
1. Determine if the Relaxing Environment Package reduces a patient’s pain during office 
administration of intra-detrusor onabotulinum toxin A injections based on a visual analog scale. 
2. Determine if the Relaxing Environment Package increases patient satisfaction with their 
procedure experience based on a visual analog scale. 
3. Determine if the Relaxing Environment Package decreases procedure staff burnout based on a 
visual analog scale. 
 
HYPOTHESIS 
We hypothesize that patients who experience a relaxing environment of lavender aromatherapy, calming 
music, dim lighting, and modest positioning during office intra-detrusor chemodenervation procedures 
will have less pre-procedure anxiety, less pain during the procedure, and greater procedure satisfaction 
compared to patients who experience a typical office setting.  We additionally hypothesize that staff who 
are exposed to the relaxing environment will experience less burnout.  
 
METHODS and MEASURES 
Design and Setting 

 
 
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This is a single center prospective randomized controlled trial of women with overactive bladder 
undergoing their first or repeat office intra-detrusor chemodenervation with onabotulinum toxin A.  The 
trial will be performed in an academic medical center outpatient Urogynecology clinic (Women’s Center 
for Pelvic Health (Mercy), Atrium Health, Charlotte, NC).  Approval by the Atrium Health Institutional 
Review Board will be obtained before data collection. 
 
Subject Selection Criteria 
Women scheduled for office intra-detrusor chemodenervation with onabotulinum toxin A for a diagnosis 
of overactive bladder (OAB), urinary urgency (UU), or urgency urinary incontinence (UUI) based on 
subjective or objective data will be identified and screened against inclusion and exclusion criteria.  If 
potential subjects meet the requirements for the study, they will be eligible to be invited for participation.  
Subjects will be consented for study enrollment by physicians, fellow physicians, and/or a delegated 
study team member on the day of their procedure. 
 
Inclusion Criteria 
• 
Non-pregnant females 
• 
Age 18 years and older 
• 
English as a primary language 
• 
Scheduled for office intra-detrusor chemodenervation for diagnosis of OAB/UU/UUI 
• 
Baseline visual analog scale for anxiety ≥12mm 
 
Exclusion Criteria 
• 
Allergy to lavender oil 
• 
Contraindication to intra-detrusor chemodenervation procedure as determined by the physician 
 
Inclusion of Women and Minorities  
Women of all races and ethnicity who meet the above-described eligibility criteria are eligible for this 
study.  All participants will be women. 
 
Study Withdrawal 
Subjects may withdraw from the study at any point in time.  Documentation of the reason for withdrawal 
will be captured in the data collection forms.  There will be no risk to subjects that choose to withdraw. 
 
Sample Size 
Our sample size calculation was based on a prior study within the urogynecologic population which 
showed a statistically significant reduction in VAS-anxiety when aromatherapy was used during 
multichannel urodynamics, a common urogynecologic office procedure8.  With a sample size of n=80 we 
would have 80% power to detect a mean clinically important difference of 12mm out of 100mm on the 
anxiety visual analog scale assuming a standard deviation of 18.8 and p-value 0.05. As the intervention is 
delivered at the week level, if we reach n=80 early in the week, we will plan to finish out the week and 
thus may reach a total sample size slightly greater than 80, increasing statistical power.  
 
Interventions and Interactions 
Patients scheduled for office intra-detrusor chemodenervation will be contacted by study staff via phone 
to introduce the study and gauge interest in participating.  Interested and eligible patients will be asked to 
arrive thirty minutes before their scheduled procedure time to complete the consent process.  Upon 
arrival, patients will be escorted to a research office where informed consent will be obtained.  After 
obtaining informed consent, all participants will fill out a pre-procedure visual analog scale (VAS) for 

 
 
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anxiety11 (Figure 1) and a VAS for pain12 (Figure 2).  If all inclusion criteria are met, including VAS-
anxiety ≥12mm on 100mm scale, participants will be enrolled and then escorted to the procedure room.  
 
Intervention:  
Group 1: Intervention 
• 
Lavender aromatherapy sticker on patient, procedure staff, MD lapel 
• 
Calming music from Sirius XM station 68 (Spa) playing via overhead speakers 
• 
Overhead lights off, two lanterns lit to provide dim lighting 
• 
Avoid stirrup use 
 
Group 2: Control 
• 
Non-aromatic (placebo) sticker on patient, procedure staff, MD lapel 
• 
No music playing 
• 
Overhead lights on 
• 
Stirrups used  
 
  
In order to create the least disruption to our clinical workflow, we propose randomizing the weeks of the 
study rather than randomizing participants.  Permuted block randomization will be used such that a 
random sequence of blocks of 4 or 6 weeks (totaling to the number of weeks planned for the study) will 
be chosen.  Within each block of 4 or 6 weeks, the weeks will be equally randomized to treatment or 
control.  For example, within a four-week block, two of four weeks will be randomized treatment and two 
to control.  Permuted block randomization will ensure that (i) prognostic factors (e.g., first-time vs. repeat 
patient) are balanced over the course of the study and (ii) seasonality is addressed (e.g., within summer, 
half of the weeks are control and half treatment).  Each week of the study will be randomized to either 
Relaxing Environment Package or Typical Office Environment (control), rather than randomizing 
individual patients.  On Monday of every week, an envelope will be opened to determine if it is a 
Relaxing Environment Package week or Control week.  Randomization will be discussed in more detail 
below. 
 
If the week is randomized to a Relaxing Environment Package, the patient, procedure staff, and MD will 
enter the procedure room and receive a lavender aromatherapy sticker to be worn on their lapels. The 
lavender aromatherapy sticker will be ordered from Aroma Stickers store website (https://aroma-
stickers.com).  Calming music from Sirius XM station 68 (Spa) will be playing softly in the background 
via overhead speakers.  If the patient had planned to listen to their own music during the procedure, this 
will be permitted and documented.  Procedure consent and preprocedural preparation (see below) will 
take place.  The overhead lights will then be turned off, and two battery powered lanterns will be lit to 
provide dim lighting.  Stirrups will be avoided, if possible, during the preparation and procedure.   
 
If the week is randomized to Typical Office Environment, the patient, procedure staff, and MD will enter 
the procedure room and receive a non-aromatic (placebo) sticker to be worn on their lapels.  The non-
aromatic sticker will be obtained from an office supply store.  No music will be playing, and all of the 
lights will be on as is typical in our practice.  Procedure consent and preprocedural preparation (see 
below) will take place.   The lights may then be adjusted during cystoscopy per provider preference for 
adequate visualization.  
 

 
 
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To minimize lavender cross contamination and unintended topical or environmental exposure in those not 
participating in the study or with lavender allergy, we opted to use a lavender aromatherapy sticker rather 
than a diffuser.  Unlike a diffuser, the aromatic sticker does not leave a scent in the air once the sticker is 
removed from the room.  When the aromatic sticker is worn on a shirt lapel it can only be smelled at close 
distances, typically only by the individual wearing the sticker.  Aromatic stickers will be maintained 
outside the procedure room in a sealed bag.  If a patient is randomized to the Relaxing Environment 
Package, the stickers will be brought into the procedure room and distributed to patients and staff.  The 
sticker will be placed on the subjects’ shirt lapel.  Once the procedure is completed the stickers will be 
recollected, placed back in the sealed bag, and disposed of by study staff.  This will limit any 
environmental exposure to lavender for the next patient.  Routine hand washing or sanitization by MD 
and procedure staff and routine cleaning of procedure room between patient encounters will limit any 
cross contamination or unintended topical exposure.  For patients or staff not participating, we believe 
that lavender levels will not be above those expected in everyday life.  Additionally, our office has a 
second procedure room that can be used for any patients with a lavender allergy.   
All patients will receive routine preprocedural antibiotic prophylaxis, sterile urethral preparation with 
betadine or chlorhexidine, and 60cc viscous intravesical 1% lidocaine will be instilled into the bladder 
with sterile technique.  After staying in the environment in the supine position with a sheet covering the 
lower half of their body and legs for at least 10 minutes while the local anesthetic takes effect, 
participants will then fill out a 2nd VAS for anxiety.  The procedure will be performed, and any patient 
requested modifications to the protocol will be recorded.  After the procedure and once participants are 
dressed, they will fill out a 2nd VAS for pain and a VAS for procedure satisfaction (Figure 3).   
 
The procedure staff and MD will fill out the Burnout Battery visual analog scale13 (Figure 4) at the start of 
the day prior to seeing any patients.  They will again complete the Burnout Battery visual analog scale at 
the day’s conclusion, after seeing their last patient.  They will also record how many chemodenervation 
procedures they participated in that day.  
 
The electronic medical record, with participant permission, will be reviewed to establish patient 
demographics, indication for procedure, whether primary or repeat procedure, and medical history.  Years 
of experience and demographic information of the procedure staff and MD will also be recorded. 
 
 
 
 
Baseline 
Procedure 
Post-
procedure 
Informed Consent 
x 
 
 
Medical History  
x 
 
 
Medication review  
 x  
 
 
*Other Demographics 
x 
 
 
VAS Anxiety #1 
x 
 
 
VAS Pain #1 
x 
 
 
Randomization 
 
x 
 
 
VAS Anxiety #2 
 
x 
 
**Procedure 
 
x 
 

 
 
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VAS Pain #2 
 
 
x 
VAS Patient Satisfaction 
 
 
x 
 
Table 1. Patient Data Collection Schedule 
*Other demographic data includes: Age (years), Race, Body Mass Index (BMI in kg/m 2), smoking status 
(current/former/never), insurance type (private/Medicare/Medicaid/None), use of aromatherapy at home 
in the last six months (yes/no) 
**Procedure data includes: first time injection (yes/no), repeat procedure (yes/no), time of patient 
entering room, time of VAS anxiety #2, protocol modifications (stirrups used, support person present, 
listening to personal music, other relaxation techniques used, etc) 
 
 
Baseline 
Start of 
clinic day 
End of 
clinic day 
Informed Consent 
x 
 
 
*Demographics 
x 
 
 
Burnout Battery 
 
x 
x 
 
 
Table 2. MD and Procedure Staff Data Collection Schedule 
*MD gender, MD years of experience performing office bladder chemodenervation, procedure staff 
gender, procedure staff years of experience supporting office procedures, MD and procedure staff use of 
aromatherapy at home in the last 6 months (yes/no) 
 
RANDOMIZATION   
A permuted block randomization scheme will be used to assign weeks in a 1:1 ratio to intervention or 
control.  The permutated blocks will prevent clinic staff from being able to predict which weeks will be 
Relaxing Environment Package or control.  However, it will not be possible to blind subjects, staff, or 
investigators.  Our statistician will be blinded.  Randomization of weeks rather than patients was selected 
to minimize impact to clinic flow and help prevent protocol deviation among our busy clinic staff who 
often have back-to-back procedures.  It will also allow assessment of procedure team burnout.  Patients 
will only participate in the study once. 
 
OUTCOME MEASURES 
Primary Outcome Measure: 
The primary outcome is to compare the mean change in patients’ anxiety level from when they arrive for 
their procedure to their anxiety level after at least 10 minutes of exposure to the relaxing or typical office 
environment (while the lidocaine anesthetic is given time to work in the bladder).  The mean change in 
anxiety levels will be compared between the intervention and control groups.  Anxiety will be assessed 
using a visual analog scale (VAS) (Figure 1).  The VAS for anxiety is a validated scale that ranges from 
0-100mm14.  0mm is equivalent to “no anxiety” and is located on the left.  100mm is equivalent to 
“extremely anxious” and is located on the right.  Subjects are asked to draw a vertical line on the scale 
that corresponds to their level of anxiety.  The first VAS anxiety score (baseline) will be collected the day 
of the procedure in the research office after obtaining consent.  The second VAS anxiety score (after 
exposure) will be collected just prior to starting the procedure after at least 10 minutes of exposure to the 
procedure room environment.  The minimum clinically important difference for VAS anxiety is a change 
of 12mm on a 100mm scale.  
 

 
 
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Secondary Outcome Measures 
Procedure pain: Pain during the chemodenervation procedure will be assessed using a visual analog 
scale for pain (Figure 2).  The VAS for pain is a validated scale that ranges from 0-100mm15. 0mm is 
equivalent to “no pain” and is located on the left. 100mm is equivalent to “worst possible pain” and is 
located on the right.   Subjects are asked to draw a vertical line on the scale that corresponds to their level 
of pain during the procedure.  Baseline scores will be collected on the day of the procedure in the research 
office after obtaining consent.  Patients will then be asked to circle the pain scores that corresponded to 
the pain experienced during the procedure. This will be collected by study staff after the procedure once 
the patient is dressed.  
 
Satisfaction with experience: Patient satisfaction with their procedure experience will be assessed using 
a visual analog scale for patient satisfaction (Figure 3).  The VAS for patient satisfaction is a validated 
scale ranging from 0-100mm16.  0mm is equivalent to “no satisfaction” and 100mm is equivalent to 
“extreme satisfaction”.   Subjects are asked to draw a vertical line that corresponds to their level of 
satisfaction with their procedure experience.  
 
Procedure team burnout: Procedure team burnout will be assessed using a Burnout Battery visual 
analog scale for healthcare worker burnout (Figure 4).  This tool was created to assess the working energy 
states of healthcare providers and is correlated with the Maslach Burnout Inventory which is a validated 
22 question survey regarding workplace burnout13.  The RN(s) assigned to chemodenervation procedures 
as well as the physician performing the procedure will fill out the Burnout Battery VAS at the beginning 
and end of the clinic day.  Providers are asked to circle the battery that represents their current energy 
level.   
 
ANALYTICAL PLAN 
Descriptive statistics will be used to summarize baseline characteristics of treatment and control groups.  
Means and standard deviations (or medians and interquartile ranges) will be used to summarize 
continuous variables such as age, and frequencies and percentages will be used to summarize categorical 
variables such as first-time vs. repeat patient.  Regression analyses will be performed to test the 
hypotheses about treatment effects on primary and secondary outcomes.  Planned regression models can 
flexibly address missing data and include covariate adjustment for important prognostic variables (such as 
first-time vs. repeat patient), as necessary.  Exploratory subgroup analyses will be performed to 
characterize treatment effects within groups of interest, such as first-time or repeat patients. 
 
SUBJECT RECRUITMENT METHODS 
All patients who plan to undergo intra-detrusor chemodenervation will be identified on the clinic schedule 
prior to their procedure, screened, and approached for participation in the study.  Informed consent will be 
obtained in a separate room prior to entering the procedure room.  Subjects who do not meet the inclusion 
or exclusion criteria will be considered screen failures.  Screen failures will be captured, and the cause for 
screen failure will be documented.   
 
If a patient agrees to participate in study, baseline demographic information and medical history will be 
collected from Encompass (EPIC) electronic medical record.   
 
All MD and procedure staff assisting with bladder chemodenervation procedures at our facility will be 
invited to participate.  Informed consent will be obtained from interested MD and procedure staff 
privately, before participating in any study procedures, so they have time to read the consent and ask 
questions.  They will be provided with a printed copy of the informed consent.  After informed consent is 
obtained baseline data will be collected. 
 

 
 
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All study data will be recorded by research staff and securely maintained at the Mercy study site.  The 
data flow will consist of paper data collection for eligibility assessment, baseline data, randomization, 
intervention group, primary and secondary outcomes, adverse events, and protocol deviations.  
 
Data will be entered by study staff into the Research Electronic Data Capture (REDCap) database that 
will be stored on a secure server at Atrium Health.  REDCap is a secure, web-based application designed 
to support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) 
audit trails for tracking data manipulation and export procedures; 3) automated export procedures for 
seamless data downloads to common statistical packages; and 4) procedures for importing data from 
external sources.  Data will be entered into REDCap within 30 business days of collection. 
 
Each subject will have a unique identification number to which only the principal and sub-investigators 
will have access.  The data collection spreadsheet will not contain any patient identifiers and will be 
password protected.  The master list that links the patients and their study identification number will be 
stored separately from the database.  All collected information will be stored separately on a password 
protected hard drive.  A back up copy of the file will be stored on a password protected hospital network 
drive.  All hard copies of study data will be stored in a locked cabinet in the office of the research nurse, 
which will also be locked. 
 
Electronic data will be stored to safe-guard confidentiality using a password protected computer.  
Principal investigator, co-investigators, research Coordinator nurse, and statisticians will have access to 
harvested patient data.  Harvested patient data and identifiers will be destroyed upon completion of data 
analysis, manuscript acceptance and publication in accordance with Atrium Research policy and 
guidelines. 
 
INFORMED CONSENT 
Signed informed consent will be obtained from each patient subject by a delegated study team member in-
person on the day of the schedule procedure. 
 
Signed informed consent will be obtained from MD and procedure staff subjects by a delegated study 
team member prior to participation in any study procedures. 
 
CONFIDENTIALITY AND PRIVACY 
Confidentiality will be protected by collecting only information needed to assess study outcomes, 
minimizing to the fullest extent possible the collection of any information that could directly identify 
subjects, and maintaining all study information in a secure manner.  To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection form.  Any collected 
patient identifying information corresponding to the unique study identifier will be maintained on a 
linkage file, store separately from the data.  The linkage file will be kept secure, with access limited to 
designated study personnel.  Following data collection subject identifying information will be destroyed 
upon completion of data analysis, manuscript acceptance and publication in accordance with Atrium 
Research policy and guidelines consistent with data validation and study design, producing an anonymous 
analytical data set.  Data access will be limited to study staff.  Data and records will be kept locked and 
secured, with any computer data password protected.  No reference to any individual participant will 
appear in reports, presentations, or publications that may arise from the study. 
 
DATA AND SAFETY MONITORING 
The principal investigator will be responsible for monitoring the data and safety of study participants.  
The principal investigator will be assisted by other members of the study staff. 
 

 
 
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REPORTING OF UNANTICIPATED PROBLEMS, ADVERSE EVENTS OR DEVIATIONS 
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol changes will 
be promptly reported by the principal investigator or designated member of the research team to the IRB 
or appropriate government agency if appropriate. 
 
 
 
FIGURES 
Figure 1  
 
 
 
Figure 2 
 
 
 
 
 
Figure 3 

 
 
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Figure 4 
 
     
 
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