AnxietyRELAXNCT06319898
Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder
A study testing Lavender aromatherapy sticker in people with Anxiety and Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). It is often performed as an office-based procedure under local anesthesia. Alternatively, it can be performed in the operating room under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Pain, Burnout, Professional
- What is being tested?
- Lavender aromatherapy sticker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2024to 12 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pregnant females
- Age 18 years and older
- English as a primary language
- Scheduled for office intra-detrusor chemodenervation for diagnosis of Over-Active Bladder (OAB)/ Urinary Urgency (UU)/ Urged Urinary Incontinence (UUI)
- Baseline visual analog scale for anxiety ≥12mm
Who cannot join
- Allergy to lavender oil
- Contraindication to intra-detrusor chemodenervation (active Urinary Tract Infection)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder: RELAX Trial
Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). 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 effective. 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 injections. Relaxation and distraction techniques are one way to ease patients' anxiety before an office-based procedure. 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 population.
The purpose of this study is to investigate whether women with Urge urinary incontinence (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. Also investigate whether exposure to the relaxing environment impacts the well-being of staff involved in these procedures. This study design is a randomized control trial. Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \& Pelvic Surgery - Mercy clinic will be invited to participate. Participants will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. The participants will complete the pre-procedure visual analog scale (VAS) for anxiety and a VAS for pain at baseline.
Read the detailed description
Aside from randomization to relaxing environment package versus placebo, no procedures will be performed for study purposes that would not be normally performed in the clinical evaluation.
Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \& Pelvic Surgery - Mercy, Charlotte North Carolina, will be invited to participate. Participants who meet inclusion criteria will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. Randomization of weeks rather than individual participants was selected to minimize impact to clinic flow. A permuted block randomization scheme will be used to assign weeks in a 1:1 ratio to intervention or control. After obtaining informed consent, all participants will fill out a baseline pre-procedural visual analog scale (VAS) for anxiety and a VAS for pain. Anxiety will be assessed using a visual analog scale (VAS)
If the week is randomized to a Relaxing Environment Package week, the patient, procedure staff, and MD will enter the procedure room and receive a lavender aromatherapy sticker to be worn on their lapels. Calming music from Sirius 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. The overhead lights will then be turned off, and two lanterns 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. No music will be playing, and all of the lights will be on as is typical in our practice. The lights may then be adjusted during cystoscopy per provider preference for adequate visualization.
All patients will receive routine preprocedural antibiotic prophylaxis, sterile urethral preparation with betadine or chlorhexidine, and 60cc viscous intravesical 1% lidocaine. After sitting in the environment for at least 10 minutes while the local anesthetic takes effect, participants will fill out a 2nd VAS for anxiety. The standard bladder chemodenervation 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. The VAS for patient satisfaction is a validated scale ranging from 0-100mm.
The procedure staff and MD will fill out the Burnout Battery visual analog scale for healthcare worker burnout at the start of the day before seeing any patients and again at the end of the day after seeing their last patient. 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 burnout. They will also record how many chemodenervation procedures they participated in that day.
- Conditions
- Anxiety, Pain, Burnout, Professional
- Being tested
- Lavender aromatherapy sticker
- Keywords
- aromatherapy, bladder botox, anxiety, lavender
- Medical subject headings
- Anxiety Disorders, Pain, Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender aromatherapy stickerBehavioural
Also called music and dim lighting
Lavender aromatherapy during procedure, music and dim lighting
| Study group | Role | What they receive |
|---|---|---|
| Lavender aromatherapy sticker | Experimental | 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 Receives: Behavioral: Lavender aromatherapy sticker |
| Control - no Intervention | No intervention | Non-aromatic (placebo) sticker on patient No music playing Overhead lights on Stirrups used |
| Procedure Team Intervention - relaxing environment | Experimental | lavender aromatherapy, calming music, and dim lighting - Members of the procedure team - participation in this research will involve a 3 question initial questionnaire survey to assess demographics and prior experience with aromatherapy and pre- and post-clinic survey on the days you participate in bladder Botox procedures. Receives: Behavioral: Lavender aromatherapy sticker |
| Procedure Team Control - no Intervention | No intervention | Members of the procedure team - participation in this research will involve a 3 question initial questionnaire survey to assess demographics and prior experience with aromatherapy and pre- and post-clinic survey on the days you participate in bladder Botox procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Visual Analog Scale (VAS) Anxiety Scores
The VAS for anxiety is a validated scale that ranges from 0-100mm. 0mm is equivalent to "no anxiety" and is located on the left. 100mm is equivalent to "extremely anxious" and is located on the right. The minimum clinically important difference for VAS anxiety is a change of 12mm on a 100mm scale.
Measured: Baseline to Minute 30
Secondary outcomes (3)
Mean Change in Visual Analog Scale (VAS) Pain During the Chemodenervation Procedure
Pain during the chemodenervation procedure will be assessed using a visual analog scale for pain. The VAS for pain is a validated scale that ranges from 0-100mm12. 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 circle a number 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.
Measured: Baseline to post-procedure up to 2 hours
Procedure Staff Burnout Scores - Burnout Battery Visual Analog Scale for Healthcare Worker Burnout
Determine if the Relaxing Environment Package decreases procedure staff burnout based on Burnout Battery visual analog scale for healthcare worker burnout. 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 burnout14. The clinic staff 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.
Measured: Baseline to post-procedure up to 2 hours
Patient Satisfaction With Their Procedure Experience Scores
Patient satisfaction with their procedure experience will be assessed using a visual analog scale for patient satisfaction. The VAS for patient satisfaction is a validated scale ranging from 0-100mm. 0mm is equivalent to "no satisfaction" and 100mm is equivalent to "extreme satisfaction". Subjects are asked to circle a number that corresponds to their level of satisfaction with their procedure experience.
Measured: post procedure up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start22 May 2024
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Megan Tarr, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319898
- Sponsor's protocol ID
- IRB00110787
- Acronym
- RELAX
- Status last verified
- Feb 2025
- First submitted
- 13 Mar 2024
- Last updated
- 22 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder: RELAX Trial
- ClinicalTrials.gov ID
- NCT06319898
- Acronym / sponsor ID
- RELAX / IRB00110787
- Conditions
- Anxiety, Pain, Burnout, Professional
- Keywords
- aromatherapy, bladder botox, anxiety, lavender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Posted 22 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chemodenervation of the bladder with onabotulinum toxin A is an effective treatment option for patients with refractory urgency urinary incontinence (UUI). 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 effective. 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 injections. Relaxation and distraction techniques are one way to ease patients' anxiety before an office-based procedure. 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 population.
The purpose of this study is to investigate whether women with Urge urinary incontinence (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. Also investigate whether exposure to the relaxing environment impacts the well-being of staff involved in these procedures. This study design is a randomized control trial. Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \& Pelvic Surgery - Mercy clinic will be invited to participate. Participants will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. The participants will complete the pre-procedure visual analog scale (VAS) for anxiety and a VAS for pain at baseline.
Detailed description
Aside from randomization to relaxing environment package versus placebo, no procedures will be performed for study purposes that would not be normally performed in the clinical evaluation.
Women scheduled for office intra-detrusor chemodenervation at Atrium Health women's Care Urogynecology \& Pelvic Surgery - Mercy, Charlotte North Carolina, will be invited to participate. Participants who meet inclusion criteria will be randomized to the relaxing environment package or the placebo group after informed consent is obtained and immediately before undergoing intra-detrusor chemodenervation. Randomization of weeks rather than individual participants was selected to minimize impact to clinic flow. A permuted block randomization scheme will be used to assign weeks in a 1:1 ratio to intervention or control. After obtaining informed consent, all participants will fill out a baseline pre-procedural visual analog scale (VAS) for anxiety and a VAS for pain. Anxiety will be assessed using a visual analog scale (VAS)
If the week is randomized to a Relaxing Environment Package week, the patient, procedure staff, and MD will enter the procedure room and receive a lavender aromatherapy sticker to be worn on their lapels. Calming music from Sirius 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. The overhead lights will then be turned off, and two lanterns 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. No music will be playing, and all of the lights will be on as is typical in our practice. The lights may then be adjusted during cystoscopy per provider preference for adequate visualization.
All patients will receive routine preprocedural antibiotic prophylaxis, sterile urethral preparation with betadine or chlorhexidine, and 60cc viscous intravesical 1% lidocaine. After sitting in the environment for at least 10 minutes while the local anesthetic takes effect, participants will fill out a 2nd VAS for anxiety. The standard bladder chemodenervation 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. The VAS for patient satisfaction is a validated scale ranging from 0-100mm.
The procedure staff and MD will fill out the Burnout Battery visual analog scale for healthcare worker burnout at the start of the day before seeing any patients and again at the end of the day after seeing their last patient. 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 burnout. They will also record how many chemodenervation procedures they participated in that day.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lavender aromatherapy sticker | Experimental | Behavioral: Lavender aromatherapy stickerLavender 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 |
| Control - no Intervention | No intervention | –Non-aromatic (placebo) sticker on patient No music playing Overhead lights on Stirrups used |
| Procedure Team Intervention - relaxing environment | Experimental | Behavioral: Lavender aromatherapy stickerlavender aromatherapy, calming music, and dim lighting - Members of the procedure team - participation in this research will involve a 3 question initial questionnaire survey to assess demographics and prior experience with aromatherapy and pre- and post-clinic survey on the days you participate in bladder Botox procedures. |
| Procedure Team Control - no Intervention | No intervention | –Members of the procedure team - participation in this research will involve a 3 question initial questionnaire survey to assess demographics and prior experience with aromatherapy and pre- and post-clinic survey on the days you participate in bladder Botox procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-pregnant females
- Age 18 years and older
- English as a primary language
- Scheduled for office intra-detrusor chemodenervation for diagnosis of Over-Active Bladder (OAB)/ Urinary Urgency (UU)/ Urged Urinary Incontinence (UUI)
- Baseline visual analog scale for anxiety ≥12mm
Key exclusion criteria (2 listed)
- Allergy to lavender oil
- Contraindication to intra-detrusor chemodenervation (active Urinary Tract Infection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lavender aromatherapy stickerAlso: music and dim lightingLavender aromatherapy during procedure, music and dim lighting | Behavioural | Lavender aromatherapy sticker, Procedure Team Intervention - relaxing environment |
Primary outcome
Mean Change in Visual Analog Scale (VAS) Anxiety Scores
Time frame: Baseline to Minute 30
The VAS for anxiety is a validated scale that ranges from 0-100mm. 0mm is equivalent to "no anxiety" and is located on the left. 100mm is equivalent to "extremely anxious" and is located on the right. The minimum clinically important difference for VAS anxiety is a change of 12mm on a 100mm scale.
3 secondary outcomes
Mean Change in Visual Analog Scale (VAS) Pain During the Chemodenervation Procedure
Time frame: Baseline to post-procedure up to 2 hours
Procedure Staff Burnout Scores - Burnout Battery Visual Analog Scale for Healthcare Worker Burnout
Time frame: Baseline to post-procedure up to 2 hours
Patient Satisfaction With Their Procedure Experience Scores
Time frame: post procedure up to 2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Tarr, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender aromatherapy sticker in people with Anxiety and Pain, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Visual Analog Scale (VAS) Anxiety Scores (time frame: Baseline to Minute 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025.