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Not yet recruiting NCT07695324

Effect of Music and Lighting on Anxiety During Urodynamic Study

No phase Interventional Lower Urinary Tract Symptoms Urinary Incontinence Voiding Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Lighting, music, Dim lighting.
Who it may be relevant to
Registry conditions: Lower Urinary Tract Symptoms, Urinary Incontinence, Voiding Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Other Standard Lighting
    Standard lighting (500 lux) during the urodynamic study.
  • Other music
    Relaxing instrumental Zen-style music played during the urodynamic study.
  • Other Dim lighting
    Ambient lighting is reduced to approximately 50 lux throughout the urodynamic study to provide a dimly lit examination environment.

Primary outcome measures

  • Change in State-Trait Anxiety Inventory (STAI) Score [Time frame: Immediately before and immediately after the urodynamic study]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07695324 · KA25/238

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗