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Heating Pad for Pain During Urological Testing
N/A
Recruiting
Led By Jasmine Tibon, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre- to post-procedure (about 30 minutes)
Summary
This trial will investigate whether using a heating pad during cystoscopy/UDS reduces patient discomfort.
Who is the study for?
This trial is for adults who can consent and understand English or Spanish, needing cystoscopy or urodynamic tests but not other treatments like bladder biopsy at the same time. It's not for those refusing participation, with contraindications to these tests, or with spinal cord injuries/lack of sensation.
What is being tested?
The study is testing if using a heating pad reduces discomfort during cystoscopy or urodynamic studies compared to a sham (fake) heating pad. Participants will be randomly assigned to receive either the real or sham heating pad during their procedure.
What are the potential side effects?
Since this trial involves an electrical heating pad versus a sham device, side effects are minimal but may include skin irritation from the heat source. The emotional distress from procedures might also vary between individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre- to post-procedure (about 30 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre- to post-procedure (about 30 minutes)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Anxiety visual analog scale (VAS)
Blood pressure measure
Change in Distress (VAS)
+3 moreSecondary study objectives
Time spent on procedure
Wait time
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Heating Pad heatedExperimental Treatment1 Intervention
An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure
Group II: Placebo heating padPlacebo Group1 Intervention
An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure
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Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
476 Previous Clinical Trials
92,783 Total Patients Enrolled
3 Trials studying Anxiety
348 Patients Enrolled for Anxiety
Jasmine Tibon, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
Jun Song, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had procedures like bladder biopsy or Botox injections during my cystoscopy.I do not wish to participate in the trial.I cannot undergo bladder exams or bladder function tests due to health reasons.I am 18 years old or older.I have a spinal cord injury or cannot feel certain parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Heating Pad heated
- Group 2: Placebo heating pad
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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