Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder

Pain Clinical Trial

— RELAX  

Official title:

Relaxing Environment to Lower Anxiety During Onabotulinum Toxin Chemodenervation of the Bladder: RELAX Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319898
• Other study ID #: IRB00110787
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2024
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Wake Forest University Health Sciences
• Contact: Megan Tarr, MD
• Phone: 704-304-1160
• Email: megan.tarr[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: February 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Allergy to lavender oil

• Contraindication to intra-detrusor chemodenervation (active Urinary Tract Infection)

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Burnout, Professional
• Pain

Intervention

Behavioral:
• Lavender aromatherapy sticker
Lavender aromatherapy during procedure, music and dim lighting

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Visual Analog Scale (VAS) Anxiety Scores	100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain - a VAS score greater than 30 mm (with a mean of 49 mm) represents "moderate pain" and a score greater than 54 mm (with a mean of 79 mm) represents "severe pain	Baseline to immediately prior to procedure
Secondary	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.	Baseline to post-procedure up to 2 hours
Secondary	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.	Baseline to post-procedure up to 2 hours
Secondary	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 0-100mm13. 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.	post procedure up to 2 hours