An interventional study of Electrical heating pad and Sham heating pad in Anxiety, Pain and Distress, Emotional, sponsored by The University of Texas Health Science Center at San Antonio. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-23.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Supportive care
Patient frequently report experiencing discomfort associated with cystoscopy or urodynamic studies (UDS), and a small percentage of patients refuse these important procedures due to discomfort or fear of discomfort. Heating pads are an inexpensive and low-risk way to reduce patient discomfort during these procedures, which to our knowledge has not been investigated in the United States.
Invasive office procedures such as cystoscopy and urodynamic studies (UDS) are commonly performed for many urologic and Urogynecologic conditions including, but not limited to, incontinence, voiding dysfunction, urinary retention, hematuria, and other lower urinary tract symptoms. Cystoscopy involves the insertion of a rigid or flexible cystoscope through the urethra and into the bladder. Urodynamic studies involve the placement of urethral and rectal catheters. Both cystoscopy and UDS involve filling the bladder with fluid, and these procedures are essential to the diagnosis and management of many of the conditions listed above.
While both procedures are office procedures that are generally well tolerated, some patients can experience significant discomfort, pain, or anxiety. Some nonpharmacologic therapies have been investigated to relieve anxiety, pain, and distress, such as music and aromatherapy. Heating treatments are also known to reduce muscle pain by increasing local blood flow and decreasing distress. The use of a heating pad has become an established complementary modality in some invasive procedures. A previous study from South Korea has shown benefit of heating pad use for anxiety, pain, and distress during cystoscopy and UDS; however to our knowledge, there are no studies evaluating the effect of heating pad use on patients in the United States, who may have inherent demographical differences compared to patients from South Korea.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
Browse Anxiety Disorders studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
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Exclusion Criteria:
An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure
Device: Electrical heating pad
An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure
Device: Sham heating pad
A powered heating pad
Also known as: Heating pad
A heating pad that is not powered on
Also known as: Non-heated heating pad
Anxiety visual analog scale (VAS)
Change in score on a 10-point visual analog scale where where 0 indicates the least amount of anxiety and 10 the greatest
Time frame: Pre- and Post-procedure (about 30 minutes)
Hospital Anxiety and Depression Survey (HADS)
Change in score on the anxiety subscale score, a total score of 0-21 is possible, with a score between 0-7= Normal, 8-10= Borderline abnormal and 11-21= abnormal
Time frame: Pre- and Post-procedure (about 30 minutes)
Change in Pain (VAS)
Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of pain and 10 the greatest
Time frame: Pre- and Post-procedure (about 30 minutes)
Change in Distress (VAS)
Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of distress and 10 the greatest
Time frame: Pre- and Post-procedure (about 30 minutes)
Blood pressure measure
Change in blood pressure
Time frame: Pre- and Post-procedure (about 30 minutes)
Heart rate
Change in heart rate
Time frame: Pre- and Post-procedure (about 30 minutes)
Wait time
Amount of time spent waiting prior to procedure
Time frame: Pre-procedure to beginning of procedure (about 30 minutes)
Time spent on procedure
Amount of time taken to complete procedure
Time frame: Pre- to Post-procedure (about 30 minutes)
Plan to share: Yes — All de-identified IPD that underlie results in a publication
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is withdrawn, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio