Bladder (Urothelial, Transitional Cell) Cancer, Hematuria
Conditions
Keywords
Cystoscopy, Bladder Cancer, Hematuria, Microhematuria
Brief summary
The goal of this study is to learn methods doctors can use to help improve the cystoscopy experience. Specifically, this study will determine if listening to music, and the amount of time Lidocaine (a numbing medication) is allowed to rest in your urethra before beginning the cystoscopy procedure, will improve the cystoscopy experience.
Detailed description
For patients undergoing cystoscopy who choose or do not choose to watch the procedure on a screen: Does long vs. short dwell-time lidocaine, and music vs. no music, more effectively reduce pain and anxiety and improve satisfaction and adherence to clinician recommendations for follow-up.
Interventions
DEVICEHeadphones
Music playlists include Jazz, New Age, and Classical. Participants randomized to listening to music will chose to listen to one of the three playlists provided. Headphones with a single-use cover will be placed over the ears prior to the administration of numbing medication, and prior to the start of the cystoscopy procedure.
DRUGDwell time 5-10 minutes
Numbing medication dwell time, 5-10 minutes.
DRUGDwell Time more than 10 minutes
Numbing medication dwell time, \>10 minutes.
Sponsors
Florian Schroeck
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
2 x 2 factorial design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing office-based cystoscopy for bladder cancer diagnosis, surveillance, or evaluation of anatomic abnormalities.
Exclusion criteria
* Allergy to or intolerance of lidocaine. * Intolerance of all offered music genre playlists (Jazz, Classical, New Age), such that no acceptable music option exists. * Known pregnancy or lactation (routine pregnancy testing is not required)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain level | Assessed immediately after each cystoscopy procedure. | Visual Analogue Scale. Scale is 0-10; higher number indicates higher level of pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | Assessed immediately after each cystoscopy procedure. | PROMIS Pain Intensity Scale v2.0 - Pain Intensity 3a. Scale is 1-5; higher number indicates higher level of pain. |
| Level of emotional distress and anxiety | Assessed immediately after each cystoscopy procedure. | PROMIS Emotional Distress-Anxiety Short Form 4a. Scale is 1-5; higher number indicates higher level of distress-anxiety. |
| Patient Satisfaction | Assessed immediately after each cystoscopy procedure; | Client Satisfaction Questionnaire (CSQ-3). Scale is 1-4; higher number indicates higher level of satisfaction. |
Countries
United States
Contacts
CONTACTLaura L Jensen, MPH
CONTACTFlorian R Schroeck, MD, MS
PRINCIPAL_INVESTIGATORFlorian R Schroeck, MD, MS
White River Junction Veterans Healthcare System
Outcome results
None listed