Heating Pad for in Office Cystoscopy and Urodynamic Testing

Pain Clinical Trial

Official title:

The Effects of a Heating Pad on Anxiety, Pain, and Distress During In-office Cystoscopy and Urodynamics: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05981794
• Other study ID #: HSC20230455H
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Jun Song, MD
• Phone: 615-686-9648
• Email: Songj5[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: December 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older
• Able to give informed consent
• Able to read and write English or Spanish

Exclusion Criteria:

• Refusal to participate
• Contraindications to cystoscopy or urodynamic testing
• Patients who receive other procedures or treatment at the time of cystoscopy, such as bladder biopsy or Botox injection
• Patients with spinal cord injury or lack of sensation

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Distress, Emotional
• Pain

Intervention

Device:
• Electrical heating pad
A powered heating pad
• Sham heating pad
A heating pad that is not powered on

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pre- and Post-procedure (about 30 minutes)
Primary	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	Pre- and Post-procedure (about 30 minutes)
Primary	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	Pre- and Post-procedure (about 30 minutes)
Primary	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	Pre- and Post-procedure (about 30 minutes)
Primary	Blood pressure measure	Change in blood pressure	Pre- and Post-procedure (about 30 minutes)
Primary	Heart rate	Change in heart rate	Pre- and Post-procedure (about 30 minutes)
Secondary	Wait time	Amount of time spent waiting prior to procedure	Pre-procedure to beginning of procedure (about 30 minutes)
Secondary	Time spent on procedure	Amount of time taken to complete procedure	Pre- to Post-procedure (about 30 minutes)