Lower Urinary Tract Symptoms, Urinary Incontinence, Voiding Dysfunction
Conditions
Keywords
Urodynamics, Anxiety, music, Lighting
Brief 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.
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.
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.
Sponsors
Baskent University Ankara Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in State-Trait Anxiety Inventory (STAI) Score | 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. |
Contacts
CONTACTMehmet Eflatun Deniz, MD
Outcome results
None listed