Lower Urinary Tract SymptomsCALM-UDSNCT07695324
Effect of Music and Lighting on Anxiety During Urodynamic Study
A study testing Standard Lighting, music and Dim lighting in people with Lower Urinary Tract Symptoms and Urinary Incontinence, run by Baskent University Ankara Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study is designed to evaluate the effects of environmental modifications, specifically music and lighting conditions, on anxiety in patients undergoing urodynamic study (UDS). Approximately 220 adult participants are planned to be randomly assigned to one of four intervention groups. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms, Urinary Incontinence, Voiding Dysfunction
- What is being tested?
- Standard Lighting, music and Dim lighting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jul 2026to 7 Sep 2026
- 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
- Adults aged 18 years or older.
- Scheduled to undergo urodynamic study (UDS) for clinical indications.
- Persistent lower urinary tract symptoms despite previous medical treatment or surgery.
- Able to understand the study procedures and complete the State-Trait Anxiety Inventory (STAI).
- Provided written informed consent.
Who cannot join
- Use of anxiolytic medications.
- Use of antiarrhythmic medications.
- Use of antihypertensive medications.
- Visual or hearing impairment that could interfere with the environmental interventions or completion of the questionnaire.
- Refusal or inability to complete the STAI questionnaire.
- Inability or unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Adana Dr.Turgut Noyan Hospital
Adana, Adana, 01170
About this study
Official title: Effect of Environmental Factors on Patient Anxiety During Urodynamic Study: A Prospective Randomized Trial
This study is designed to evaluate the effects of environmental modifications, specifically music and lighting conditions, on anxiety in patients undergoing urodynamic study (UDS). Approximately 220 adult participants are planned to be randomly assigned to one of four intervention groups. Anxiety levels before and after the procedure will be assessed using the State-Trait Anxiety Inventory (STAI). The study aims to determine the independent and combined effects of music and lighting on patient anxiety during UDS.
Read the detailed description
Urodynamic study (UDS) is an important diagnostic procedure for evaluating lower urinary tract dysfunction. Because UDS requires urethral and rectal catheterization, many patients experience anxiety before and during the procedure. This study is designed to evaluate whether environmental modifications, including relaxing music and dim lighting, reduce anxiety during UDS.
Approximately 220 adult participants are planned to be enrolled and randomly assigned in a 1:1:1:1 ratio to one of four groups: standard lighting without music, standard lighting with music, dim lighting without music, and dim lighting with music. Anxiety will be assessed before and after the procedure using the State-Trait Anxiety Inventory (STAI). Secondary outcome measures will include heart rate and blood pressure changes. The study will evaluate the independent and combined effects of music and lighting using a 2 × 2 factorial design.
- Being tested
- Standard Lighting, music, Dim lighting
- Keywords
- Urodynamics, Anxiety, music, Lighting
- Medical subject headings
- Lower Urinary Tract Symptoms, Urinary Incontinence, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard LightingOther
Standard lighting (500 lux) during the urodynamic study.
musicOther
Relaxing instrumental Zen-style music played during the urodynamic study.
Dim lightingOther
Ambient lighting is reduced to approximately 50 lux throughout the urodynamic study to provide a dimly lit examination environment.
| Study group | Role | What they receive |
|---|---|---|
| Standard Lighting Without Music | Experimental | Participants undergo urodynamic study under standard lighting without music. Receives: Other: Standard Lighting |
| Standard Lighting With Music | Experimental | Participants undergo urodynamic study under standard lighting while listening to relaxing instrumental music. Receives: Other: Standard Lighting; Other: music |
| Dim Lighting Without Music | Experimental | Participants undergo urodynamic study under dim lighting without music. Receives: Other: Dim lighting |
| Dim Lighting With Music | Experimental | Participants undergo urodynamic study under dim lighting while listening to relaxing instrumental music. Receives: Other: music; Other: Dim lighting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State-Trait Anxiety Inventory (STAI) Score
The primary outcome is the change in State-Trait Anxiety Inventory (STAI) score from before to after the urodynamic study. The STAI is a validated questionnaire used to assess anxiety, with higher scores indicating greater anxiety. The change in score will be compared between the four intervention groups.
Measured: Immediately before and immediately after the urodynamic study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start6 Jul 2026
- Primary completion6 Sep 2026
- Study completion7 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies 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
- Factorial
- Model description
- Participants will be randomly assigned in a 1:1:1:1 ratio to one of four intervention groups using a 2 × 2 factorial design. The interventions consist of two environmental factors: music (present or absent) and lighting (standard or dim). This design allows evaluation of the independent effects of each intervention as well as their interaction.
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Eflatun Deniz, Baskent University Ankara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695324
- Sponsor's protocol ID
- KA25/238
- Acronym
- CALM-UDS
- Status last verified
- Sep 2026
- First submitted
- 6 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the study contains potentially identifiable clinical information. De-identified aggregate data may be available from the corresponding investigator upon reasonable request, subject to institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Environmental Factors on Patient Anxiety During Urodynamic Study: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07695324
- Acronym / sponsor ID
- CALM-UDS / KA25/238
- Keywords
- Urodynamics, Anxiety, music, Lighting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- 6 Sep 2026 (actual)
- Study completion
- 7 Sep 2026 (actual)
- First posted
- 10 Jul 2026 (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.
This study is designed to evaluate the effects of environmental modifications, specifically music and lighting conditions, on anxiety in patients undergoing urodynamic study (UDS). Approximately 220 adult participants are planned to be randomly assigned to one of four intervention groups. Anxiety levels before and after the procedure will be assessed using the State-Trait Anxiety Inventory (STAI). The study aims to determine the independent and combined effects of music and lighting on patient anxiety during UDS.
Detailed description
Urodynamic study (UDS) is an important diagnostic procedure for evaluating lower urinary tract dysfunction. Because UDS requires urethral and rectal catheterization, many patients experience anxiety before and during the procedure. This study is designed to evaluate whether environmental modifications, including relaxing music and dim lighting, reduce anxiety during UDS.
Approximately 220 adult participants are planned to be enrolled and randomly assigned in a 1:1:1:1 ratio to one of four groups: standard lighting without music, standard lighting with music, dim lighting without music, and dim lighting with music. Anxiety will be assessed before and after the procedure using the State-Trait Anxiety Inventory (STAI). Secondary outcome measures will include heart rate and blood pressure changes. The study will evaluate the independent and combined effects of music and lighting using a 2 × 2 factorial design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be randomly assigned in a 1:1:1:1 ratio to one of four intervention groups using a 2 × 2 factorial design. The interventions consist of two environmental factors: music (present or absent) and lighting (standard or dim). This design allows evaluation of the independent effects of each intervention as well as their interaction.
| Arm | Type | Receives |
|---|---|---|
| Standard Lighting Without Music | Experimental | Other: Standard LightingParticipants undergo urodynamic study under standard lighting without music. |
| Standard Lighting With Music | Experimental | Other: Standard Lighting, Other: musicParticipants undergo urodynamic study under standard lighting while listening to relaxing instrumental music. |
| Dim Lighting Without Music | Experimental | Other: Dim lightingParticipants undergo urodynamic study under dim lighting without music. |
| Dim Lighting With Music | Experimental | Other: music, Other: Dim lightingParticipants undergo urodynamic study under dim lighting while listening to relaxing instrumental music. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Scheduled to undergo urodynamic study (UDS) for clinical indications.
- Persistent lower urinary tract symptoms despite previous medical treatment or surgery.
- Able to understand the study procedures and complete the State-Trait Anxiety Inventory (STAI).
- Provided written informed consent.
Key exclusion criteria (6 listed)
- Use of anxiolytic medications.
- Use of antiarrhythmic medications.
- Use of antihypertensive medications.
- Visual or hearing impairment that could interfere with the environmental interventions or completion of the questionnaire.
- Refusal or inability to complete the STAI questionnaire.
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 |
|---|---|---|
| Standard LightingStandard lighting (500 lux) during the urodynamic study. | Other | Standard Lighting With Music, Standard Lighting Without Music |
| musicRelaxing instrumental Zen-style music played during the urodynamic study. | Other | Dim Lighting With Music, Standard Lighting With Music |
| Dim lightingAmbient lighting is reduced to approximately 50 lux throughout the urodynamic study to provide a dimly lit examination environment. | Other | Dim Lighting With Music, Dim Lighting Without Music |
Primary outcome
Change in State-Trait Anxiety Inventory (STAI) Score
Time frame: Immediately before and immediately after the urodynamic study
The primary outcome is the change in State-Trait Anxiety Inventory (STAI) score from before to after the urodynamic study. The STAI is a validated questionnaire used to assess anxiety, with higher scores indicating greater anxiety. The change in score will be compared between the four intervention groups.
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 29 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the study contains potentially identifiable clinical information. De-identified aggregate data may be available from the corresponding investigator upon reasonable request, subject to institutional and ethical approval.
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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 Standard Lighting, music and Dim lighting in people with Lower Urinary Tract Symptoms and Urinary Incontinence, run by Baskent University Ankara Hospital 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 5 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 29 Sep 2026. 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?
Change in State-Trait Anxiety Inventory (STAI) Score (time frame: Immediately before and immediately after the urodynamic study). 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 29 Sep 2026.