Standard Lighting
OtherStandard lighting (500 lux) during the urodynamic study.
NCT Number: NCT07695324
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard lighting (500 lux) during the urodynamic study.
Relaxing instrumental Zen-style music played during the urodynamic study.
Ambient lighting is reduced to approximately 50 lux throughout the urodynamic study to provide a dimly lit examination environment.
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.
Contact information is provided by the study sponsor or research team.
Baskent University Ankara Hospital
Other
Effect of Environmental Factors on Patient Anxiety During Urodynamic Study: A Prospective Randomized Trial
Acronym: CALM-UDS
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