A Phase 3 interventional study of Headphones and Dwell time 5-10 minutes in Bladder (Urothelial, Transitional Cell) Cancer and Hematuria, sponsored by Florian Schroeck. Not yet recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Florian Schroeck · Phase 3, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Listening to music and 5-10 minute numbing medication dwell time
Device: Headphones · Drug: Dwell time 5-10 minutes
5 - 10 minute numbing medication dwell time
Drug: Dwell time 5-10 minutes
Listening to music and \>10 minute numbing medication dwell time
Device: Headphones · Drug: Dwell Time more than 10 minutes
\>10 minute numbing medication dwell time
Drug: Dwell Time more than 10 minutes
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.
Also known as: Music
Numbing medication dwell time, 5-10 minutes.
Also known as: Short Lidocaine
Numbing medication dwell time, \>10 minutes.
Also known as: Long Lidocaine
Pain level
Visual Analogue Scale. Scale is 0-10; higher number indicates higher level of pain
Time frame: Assessed immediately after each cystoscopy procedure.
Pain intensity
PROMIS Pain Intensity Scale v2.0 - Pain Intensity 3a. Scale is 1-5; higher number indicates higher level of pain.
Time frame: Assessed immediately after each cystoscopy procedure.
Level of emotional distress and anxiety
PROMIS Emotional Distress-Anxiety Short Form 4a. Scale is 1-5; higher number indicates higher level of distress-anxiety.
Time frame: Assessed immediately after each cystoscopy procedure.
Patient Satisfaction
Client Satisfaction Questionnaire (CSQ-3). Scale is 1-4; higher number indicates higher level of satisfaction.
Time frame: Assessed immediately after each cystoscopy procedure;
Plan to share: Yes — De-identified clinical and quality of life data, data on intervention administration, mixed-methods data on implementation of the study interventions, and metadata will be shared via a Generalist repository that is participating in the NIH Generalist Repository Ecosystem Initiative.
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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