AnxietyNCT05981794
Heating Pad for in Office Cystoscopy and Urodynamic Testing
A study testing Electrical heating pad in people with Anxiety and Pain, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pain, Distress, Emotional
- What is being tested?
- Electrical heating pad
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Able to give informed consent
- Able to read and write English or Spanish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: The Effects of a Heating Pad on Anxiety, Pain, and Distress During In-office Cystoscopy and Urodynamics: a Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Anxiety, Pain, Distress, Emotional
- Being tested
- Electrical heating pad, Sham heating pad
- Keywords
- Cystoscopy, Urodynamic study
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical heating padDevice
Also called Heating pad
A powered heating pad
Sham heating padDevice
Also called Non-heated heating pad
A heating pad that is not powered on
| Study group | Role | What they receive |
|---|---|---|
| Heating Pad heated | Experimental | An electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure Receives: Device: Electrical heating pad |
| Placebo heating pad | Placebo comparator | An electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure Receives: Device: Sham heating pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre- and Post-procedure (about 30 minutes)
Blood pressure measure
Change in blood pressure
Measured: Pre- and Post-procedure (about 30 minutes)
Heart rate
Change in heart rate
Measured: Pre- and Post-procedure (about 30 minutes)
Secondary outcomes (2)
Wait time
Amount of time spent waiting prior to procedure
Measured: Pre-procedure to beginning of procedure (about 30 minutes)
Time spent on procedure
Amount of time taken to complete procedure
Measured: Pre- to Post-procedure (about 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: PI left institution and changed to new PI, there was no funding secured for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 manner to the treatment group (those receiving a heating pad with heat during the procedure) or control group (those who receive a heating pad without heat). The study is prospective, and randomization will be performed by a random allocation table. Randomization will be stratified by sex, procedure, and provider.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jasmine Tibon, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981794
- Sponsor's protocol ID
- HSC20230455H
- Status last verified
- May 2025
- First submitted
- 22 Jul 2023
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All de-identified IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Heating Pad on Anxiety, Pain, and Distress During In-office Cystoscopy and Urodynamics: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05981794
- Acronym / sponsor ID
- HSC20230455H
- Conditions
- Anxiety, Pain, Distress, Emotional
- Keywords
- Cystoscopy, Urodynamic study
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution and changed to new PI, there was no funding secured for this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 manner to the treatment group (those receiving a heating pad with heat during the procedure) or control group (those who receive a heating pad without heat). The study is prospective, and randomization will be performed by a random allocation table. Randomization will be stratified by sex, procedure, and provider.
| Arm | Type | Receives |
|---|---|---|
| Heating Pad heated | Experimental | Device: Electrical heating padAn electrical heating pad will be applied prior to the cystoscopy or urodynamic procedure |
| Placebo heating pad | Placebo comparator | Device: Sham heating padAn electrical heating pad that is not heated will be applied prior to the cystoscopy or urodynamic procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Able to give informed consent
- Able to read and write English or Spanish
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical heating padAlso: Heating padA powered heating pad | Device | Heating Pad heated |
| Sham heating padAlso: Non-heated heating padA heating pad that is not powered on | Device | Placebo heating pad |
Primary outcome
Anxiety visual analog scale (VAS)
Time frame: Pre- and Post-procedure (about 30 minutes)
Change in score on a 10-point visual analog scale where where 0 indicates the least amount of anxiety and 10 the greatest
Hospital Anxiety and Depression Survey (HADS)
Time frame: Pre- and Post-procedure (about 30 minutes)
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
Change in Pain (VAS)
Time frame: Pre- and Post-procedure (about 30 minutes)
Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of pain and 10 the greatest
Change in Distress (VAS)
Time frame: Pre- and Post-procedure (about 30 minutes)
Change in score on a visual analog scale (VAS) from 0-10, where 0 indicates the least amount of distress and 10 the greatest
Blood pressure measure
Time frame: Pre- and Post-procedure (about 30 minutes)
Change in blood pressure
Heart rate
Time frame: Pre- and Post-procedure (about 30 minutes)
Change in heart rate
2 secondary outcomes
Wait time
Time frame: Pre-procedure to beginning of procedure (about 30 minutes)
Time spent on procedure
Time frame: Pre- to Post-procedure (about 30 minutes)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: Yes. All de-identified IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasmine Tibon, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical heating pad in people with Anxiety and Pain, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety visual analog scale (VAS) (time frame: Pre- and Post-procedure (about 30 minutes)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.