Health TrialsbyHealthPanel

Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)

ConditionsBladder (Urothelial, Transitional Cell) CancerHematuria
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorian Schroeck

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing office-based cystoscopy for bladder cancer diagnosis, surveillance, or evaluation of anatomic abnormalities.

Disqualifiers

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)

Trial design

Design model

Factorial

Treatments tested in this trial

  • Headphones

    Device

    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.

  • Dwell time 5-10 minutes

    Drug

    Numbing medication dwell time, 5-10 minutes.

  • Dwell Time more than 10 minutes

    Drug

    Numbing medication dwell time, \>10 minutes.

Treatment groups

1,740 Participants
are divided into 4 treatment groups
Group A: Music and short dwell timeExperimental treatment 2 interventions
Group B: No music and short dwell timeActive comparator 1 intervention
Group C: Music and long dwell timeExperimental treatment 2 interventions
Group D: No music and long dwell timeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain level

Visual Analogue Scale. Scale is 0-10; higher number indicates higher level of pain

Time frame
Assessed immediately after each cystoscopy procedure.

Secondary outcomes

1

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.
2

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.
3

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;

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florian Schroeck

Lead sponsor

White River Junction Veterans Affairs Medical Center

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: