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NCT Number: NCT07695324

Effect of Music and Lighting on Anxiety During Urodynamic Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 informed consent.

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 informed consent.

Treatment and study plan

Standard Lighting

Other

Standard lighting (500 lux) during the urodynamic study.

Music

Other

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

Dim lighting

Other

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

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Eflatun Deniz, MD

CONTACT

[email protected]

+905304079085

Sponsors and collaborators

Lead sponsor

Baskent University Ankara Hospital

Other

Registry information

Official study title

Effect of Environmental Factors on Patient Anxiety During Urodynamic Study: A Prospective Randomized Trial

Acronym: CALM-UDS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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