Nursing CareNCT07207746
Effect of Music on Pain, Embarrassment, and Urodynamic Outcomes
A study testing Behavioral: Music Listening in people with Nursing Care and Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Urodynamic testing (UDT) is a diagnostic procedure frequently used to evaluate lower urinary tract dysfunction, including urinary incontinence and voiding difficulties. Despite its diagnostic value, UDT is invasive and often causes discomfort, pain, and embarrassment due to catheter placement and repeated… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Care, Pain, Music Intervention
- What is being tested?
- Behavioral: Music Listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Jun 2025
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged ≥18 years who are able to read and write
- Patients scheduled for urodynamic testing
- Patients with no visual, auditory, or cognitive impairments
- Patients without chronic pain
Who cannot join
- Patients who received sedation during the procedure.
- Pregnant women.
- Patients with a permanent urinary catheter.
- Patients with recurrent or active urinary tract infections.
- Patients requiring urodynamics due to urinary retention.
- Patients with a history of previous urodynamic testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Music on Pain, Embarrassment, and Urodynamic Outcomes During Urodynamic Testing: A Randomized Controlled Trial
Urodynamic testing (UDT) is a diagnostic procedure frequently used to evaluate lower urinary tract dysfunction, including urinary incontinence and voiding difficulties. Despite its diagnostic value, UDT is invasive and often causes discomfort, pain, and embarrassment due to catheter placement and repeated measurements. These negative experiences may reduce patient compliance, affect diagnostic accuracy, and increase reluctance to repeat the procedure.
Music has been shown to promote relaxation and reduce pain and anxiety in various clinical settings, but its effect during urodynamic testing has not been adequately studied. This randomized controlled trial was designed to determine whether listening to music during invasive UDT can reduce pain and embarrassment while influencing urodynamic parameters.
Read the detailed description
Urodynamic testing (UDT) is an outpatient diagnostic method used to assess bladder function in patients with lower urinary tract disorders such as urinary incontinence or voiding dysfunction. The procedure involves catheter insertion into the urethra, rectum, or vagina to measure intravesical, detrusor, and urethral pressure, and may include electromyographic evaluation of the external urethral sphincter. UDT typically consists of uroflowmetry, cystometry, and pressure-flow studies, during which urine flow rate and the relationship between intravesical pressure and urine flow are evaluated.
Although essential for diagnosis and treatment planning, UDT is often experienced as stressful and uncomfortable by patients. Pain, embarrassment, and emotional distress are frequently reported due to the invasive nature of catheter placement. These negative experiences may impair patient cooperation, affect the accuracy of urodynamic measurements, and reduce willingness to undergo repeated testing when required for monitoring. Nurses play a key role in preparing and supporting patients during UDT through education, positioning, catheter placement, privacy protection, and emotional support. However, evidence-based complementary strategies to improve patient comfort during UDT remain limited.
Music is a widely recommended nonpharmacological intervention that promotes relaxation, reduces anxiety and pain, and enhances patient satisfaction during invasive procedures. It is safe, cost-effective, and easy to implement. Previous studies have demonstrated that music can improve patient comfort in urological and gastrointestinal procedures, but no randomized controlled trials have specifically investigated its effect during UDT. Considering that patient anxiety and discomfort may influence urination and detrusor function during pressure-flow studies, interventions that improve comfort may also enhance test reliability.
This randomized controlled trial was therefore designed to evaluate the effect of listening to music during invasive urodynamic testing on patient-reported pain, embarrassment, and urodynamic outcomes. The results are expected to contribute to the evidence base for simple, safe, and cost-effective nursing interventions that improve patient comfort and cooperation during UDT.
- Conditions
- Nursing Care, Pain, Music Intervention
- Being tested
- Behavioral: Music Listening
- Keywords
- music intervention, pain, embarrassment, urodynamic testing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Music ListeningBehavioural
Participants listened to slow-tempo instrumental classical music (40-60 dB) via headphones during the entire urodynamic procedure.
| Study group | Role | What they receive |
|---|---|---|
| Music Arm | Experimental | Participants in this group listened to slow-tempo (60-80 beats/min) instrumental classical music at a sound level of 40-60 dB throughout the urodynamic procedure (average 30 minutes). Music was delivered via headphones, starting before uroflowmetry and continuing until the end of voiding cystometry. Standard multi-channel urodynamic testing was performed according to the International Continence Society (ICS) Good Urodynamic Practice Guidelines. An 8 Fr cystometry catheter was inserted into the bladder to measure intravesical pressure, and a 4.5 Fr rectal catheter was used to measure intra-abdominal pressure. Urodynamic parameters including bladder capacity, leakage point pressure, detrusor contraction, maximum flow rate (Qmax), detrusor pressure at maximum flow (PdetQmax), and post-void residual volume were recorded. Pain and embarrassment were assessed at three time points: uroflowmetry, sitting on the table, and catheter insertion. Receives: Behavioral: Behavioral: Music Listening |
| Control Arm | No intervention | Participants in this group received standard care during the urodynamic procedure. No music intervention was applied. All procedures were performed under identical conditions following ICS Good Urodynamic Practice Guidelines, with the same catheter sizes and positioning protocol. Pain and embarrassment levels were assessed at the same three time points as in the music group. Urodynamic outcomes were recorded in parallel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level at Baseline (VAS-P)
Pain assessed with a 100 mm VAS (0 = no pain, 10 = worst pain).
Measured: T1: 0 minute (before procedure) (Score on a 0-10 scale)
Pain Level During Procedure (VAS-P)
Pain assessed with a 100 mm VAS.
Measured: T2: 15 minutes (during procedure) (Score on a 0-10 scale)
Pain Level at End of Procedure (VAS-P)
Pain assessed with a 100 mm VAS.
Measured: T3: 30 minutes (end of procedure) (Score on a 0-10 scale)
Embarrassment Level at Baseline (VAS-E)
Embarrassment assessed with a 100 mm VAS (0 = no embarrassment, 10 = maximum embarrassment).
Measured: T1: 0 minute (before procedure) (Score on a 0-10 scale)
Embarrassment Level During Procedure (VAS-E)
Embarrassment assessed with a 100 mm VAS.
Measured: T2: 15 minutes (during procedure) (Score on a 0-10 scale)
Embarrassment Level at End of Procedure (VAS-E)
Embarrassment assessed with a 100 mm VAS.
Measured: T3: 30 minutes (end of procedure) (Score on a 0-10 scale)
Secondary outcomes (2)
Maximum Flow Rate (Qmax)
Maximum urine flow rate recorded during pressure-flow study.
Measured: Day 1, single measurement during voiding phase (mL/s)
Detrusor Pressure at Maximum Flow (PdetQmax)
Detrusor pressure measured at maximum urine flow.
Measured: Day 1, single measurement during voiding phase (cmH₂O)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start1 Feb 2024
- Primary completion5 Feb 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CareStudies 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
- The study was conducted experimentally with a pre-test and post-test control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN ÖZHANLI, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207746
- Sponsor's protocol ID
- 2024/01.03
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music on Pain, Embarrassment, and Urodynamic Outcomes During Urodynamic Testing: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07207746
- Acronym / sponsor ID
- 2024/01.03
- Conditions
- Nursing Care, Pain, Music Intervention
- Keywords
- music intervention, pain, embarrassment, urodynamic testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 6 Oct 2025 (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.
Urodynamic testing (UDT) is a diagnostic procedure frequently used to evaluate lower urinary tract dysfunction, including urinary incontinence and voiding difficulties. Despite its diagnostic value, UDT is invasive and often causes discomfort, pain, and embarrassment due to catheter placement and repeated measurements. These negative experiences may reduce patient compliance, affect diagnostic accuracy, and increase reluctance to repeat the procedure.
Music has been shown to promote relaxation and reduce pain and anxiety in various clinical settings, but its effect during urodynamic testing has not been adequately studied. This randomized controlled trial was designed to determine whether listening to music during invasive UDT can reduce pain and embarrassment while influencing urodynamic parameters.
Detailed description
Urodynamic testing (UDT) is an outpatient diagnostic method used to assess bladder function in patients with lower urinary tract disorders such as urinary incontinence or voiding dysfunction. The procedure involves catheter insertion into the urethra, rectum, or vagina to measure intravesical, detrusor, and urethral pressure, and may include electromyographic evaluation of the external urethral sphincter. UDT typically consists of uroflowmetry, cystometry, and pressure-flow studies, during which urine flow rate and the relationship between intravesical pressure and urine flow are evaluated.
Although essential for diagnosis and treatment planning, UDT is often experienced as stressful and uncomfortable by patients. Pain, embarrassment, and emotional distress are frequently reported due to the invasive nature of catheter placement. These negative experiences may impair patient cooperation, affect the accuracy of urodynamic measurements, and reduce willingness to undergo repeated testing when required for monitoring. Nurses play a key role in preparing and supporting patients during UDT through education, positioning, catheter placement, privacy protection, and emotional support. However, evidence-based complementary strategies to improve patient comfort during UDT remain limited.
Music is a widely recommended nonpharmacological intervention that promotes relaxation, reduces anxiety and pain, and enhances patient satisfaction during invasive procedures. It is safe, cost-effective, and easy to implement. Previous studies have demonstrated that music can improve patient comfort in urological and gastrointestinal procedures, but no randomized controlled trials have specifically investigated its effect during UDT. Considering that patient anxiety and discomfort may influence urination and detrusor function during pressure-flow studies, interventions that improve comfort may also enhance test reliability.
This randomized controlled trial was therefore designed to evaluate the effect of listening to music during invasive urodynamic testing on patient-reported pain, embarrassment, and urodynamic outcomes. The results are expected to contribute to the evidence base for simple, safe, and cost-effective nursing interventions that improve patient comfort and cooperation during UDT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was conducted experimentally with a pre-test and post-test control group.
| Arm | Type | Receives |
|---|---|---|
| Music Arm | Experimental | Behavioral: Behavioral: Music ListeningParticipants in this group listened to slow-tempo (60-80 beats/min) instrumental classical music at a sound level of 40-60 dB throughout the urodynamic procedure (average 30 minutes). Music was delivered via headphones, starting before uroflowmetry and continuing until the end of voiding cystometry. Standard multi-channel urodynamic testing was performed according to the International Continence Society (ICS) Good Urodynamic Practice Guidelines. An 8 Fr cystometry catheter was inserted into the bladder to measure intravesical pressure, and a 4.5 Fr rectal catheter was used to measure intra-abdominal pressure. Urodynamic parameters including bladder capacity, leakage point pressure, detrusor contraction, maximum flow rate (Qmax), detrusor pressure at maximum flow (PdetQmax), and post-void residual volume were recorded. Pain and embarrassment were assessed at three time points: uroflowmetry, sitting on the table, and catheter insertion. |
| Control Arm | No intervention | –Participants in this group received standard care during the urodynamic procedure. No music intervention was applied. All procedures were performed under identical conditions following ICS Good Urodynamic Practice Guidelines, with the same catheter sizes and positioning protocol. Pain and embarrassment levels were assessed at the same three time points as in the music group. Urodynamic outcomes were recorded in parallel. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged ≥18 years who are able to read and write
- Patients scheduled for urodynamic testing
- Patients with no visual, auditory, or cognitive impairments
- Patients without chronic pain
Key exclusion criteria (6 listed)
- Patients who received sedation during the procedure.
- Pregnant women.
- Patients with a permanent urinary catheter.
- Patients with recurrent or active urinary tract infections.
- Patients requiring urodynamics due to urinary retention.
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 |
|---|---|---|
| Behavioral: Music ListeningParticipants listened to slow-tempo instrumental classical music (40-60 dB) via headphones during the entire urodynamic procedure. | Behavioural | Music Arm |
Primary outcome
Pain Level at Baseline (VAS-P)
Time frame: T1: 0 minute (before procedure) (Score on a 0-10 scale)
Pain assessed with a 100 mm VAS (0 = no pain, 10 = worst pain).
Pain Level During Procedure (VAS-P)
Time frame: T2: 15 minutes (during procedure) (Score on a 0-10 scale)
Pain assessed with a 100 mm VAS.
Pain Level at End of Procedure (VAS-P)
Time frame: T3: 30 minutes (end of procedure) (Score on a 0-10 scale)
Pain assessed with a 100 mm VAS.
Embarrassment Level at Baseline (VAS-E)
Time frame: T1: 0 minute (before procedure) (Score on a 0-10 scale)
Embarrassment assessed with a 100 mm VAS (0 = no embarrassment, 10 = maximum embarrassment).
Embarrassment Level During Procedure (VAS-E)
Time frame: T2: 15 minutes (during procedure) (Score on a 0-10 scale)
Embarrassment assessed with a 100 mm VAS.
Embarrassment Level at End of Procedure (VAS-E)
Time frame: T3: 30 minutes (end of procedure) (Score on a 0-10 scale)
Embarrassment assessed with a 100 mm VAS.
2 secondary outcomes
Maximum Flow Rate (Qmax)
Time frame: Day 1, single measurement during voiding phase (mL/s)
Detrusor Pressure at Maximum Flow (PdetQmax)
Time frame: Day 1, single measurement during voiding phase (cmH₂O)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Music Listening in people with Nursing Care and Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 6 Oct 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 Turkey (Türkiye). 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain Level at Baseline (VAS-P) (time frame: T1: 0 minute (before procedure) (Score on a 0-10 scale)). 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 6 Oct 2025.