Effect of Music and Lighting on Anxiety During Urodynamic Study

N/ANot Yet RecruitingNCT07695324

Baskent University Ankara Hospital220 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

220

Conditions

Lower Urinary Tract Symptoms

Interventions

Standard LightingOTHER

Standard lighting (500 lux) during the urodynamic study.

musicOTHER

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

Dim lightingOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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