ClinicalTrials.gg
CompletedNCT07695324CALM-UDSUpdated Sep 29, 2026

Effect of Music and Lighting on Anxiety During Urodynamic Study

An interventional study of Standard Lighting and music in Lower Urinary Tract Symptoms, Urinary Incontinence and Voiding Dysfunction, sponsored by Baskent University Ankara Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Primary conditionUrinary IncontinenceRegistry: Lower Urinary Tract SymptomsReclassifiedWhy we changed it
Registry
Lower Urinary Tract Symptoms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Urinary Incontinence
Why
  1. The study's listed conditions name Urinary Incontinence, a narrower term within Lower Urinary Tract Symptoms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Baskent University Ankara Hospital · Not applicable, Interventional, and Supportive care

Updated Sep 29, 2026Now CompletedFirst site in Turkey (Türkiye)+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Lower Urinary Tract Symptoms
  • Urinary Incontinence
  • Voiding Dysfunction

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Keywords

  • Urodynamics
  • Anxiety
  • music
  • Lighting
03

In context

Urinary Incontinence Reclassified

983 studies on the registry are indexed under Urinary Incontinence; 180 are open to participants now.

This study's enrollment of 220 is above the median of 66 across 739 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Baskent University Ankara Hospital is the lead sponsor of 18 studies on the registry; 3 are open to participants now.

Compared within Urinary Incontinence, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lower Urinary Tract Symptoms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    Standard Lighting Without Music

    Participants undergo urodynamic study under standard lighting without music.

    Other: Standard Lighting

  • Experimental
    Standard Lighting With Music

    Participants undergo urodynamic study under standard lighting while listening to relaxing instrumental music.

    Other: Standard Lighting · Other: music

  • Experimental
    Dim Lighting Without Music

    Participants undergo urodynamic study under dim lighting without music.

    Other: Dim lighting

  • Experimental
    Dim Lighting With Music

    Participants undergo urodynamic study under dim lighting while listening to relaxing instrumental music.

    Other: music · Other: Dim lighting

Interventions

  • OtherStandard Lighting

    Standard lighting (500 lux) during the urodynamic study.

  • Othermusic

    Relaxing instrumental Zen-style music played during the urodynamic study.

  • OtherDim lighting

    Ambient lighting is reduced to approximately 50 lux throughout the urodynamic study to provide a dimly lit examination environment.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately before and immediately after the urodynamic study

07

Study locations

1 site
  • Baskent University Adana Dr.Turgut Noyan Hospital
    Adana, Adana 01170, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2026 to primary completion in Sep 2026, 2 months.

Of 301 non-industry interventional studies with no phase under Urinary Incontinence, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 2 months is below that.

Counting every sponsor, half of 364 studies reached it within 15 months; a quarter within 7 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2026
First posted
Jul 10, 2026
StartActual
Jul 6, 2026
Primary completionActual
Sep 6, 2026
CompletionActual
Sep 7, 2026
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Completed
changed Sep 29, 2026
Sites
1 site added — first site in Turkey (Türkiye)
Show site
  • Baskent University Adana Dr.Turgut Noyan Hospital · Adana, Turkey (Türkiye)
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Not yet recruiting→Completed
    1 site added — first site in Turkey (Türkiye)
    Show site
    • Baskent University Adana Dr.Turgut Noyan Hospital · Adana, Turkey (Türkiye)
    + 3 other changes: verification date, date precision and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07695324
Lead sponsor
Baskent University Ankara Hospital
Responsible party
Mehmet Eflatun Deniz (Assistant Professor, Baskent University Ankara Hospital) — Principal investigator
First posted
Jul 10, 2026
Start date
Jul 6, 2026
Primary completion
Sep 6, 2026
Completion
Sep 7, 2026
Last update
Sep 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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