Effect of Music and Lighting on Anxiety During Urodynamic Study

NCT07695324 | Not Yet Recruiting

• 1 other identifier: KA25/238
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lower Urinary Tract Symptoms; Urinary Incontinence; Voiding Dysfunction

Keywords

Urodynamics; Anxiety; music; Lighting

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately before and immediately after the urodynamic study

Study Arms (4)

Standard Lighting Without Music

EXPERIMENTAL

Participants undergo urodynamic study under standard lighting without music.

Other: Standard Lighting

Standard Lighting With Music

EXPERIMENTAL

Participants undergo urodynamic study under standard lighting while listening to relaxing instrumental music.

Other: Standard Lighting; Other: music

Dim Lighting Without Music

EXPERIMENTAL

Participants undergo urodynamic study under dim lighting without music.

Other: Dim lighting

Dim Lighting With Music

EXPERIMENTAL

Participants undergo urodynamic study under dim lighting while listening to relaxing instrumental music.

Other: music; Other: Dim lighting

Interventions

Standard Lighting OTHER

Standard lighting (500 lux) during the urodynamic study.

Standard Lighting With Music; Standard Lighting Without Music

music OTHER

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

Dim Lighting With Music; Standard Lighting With Music

Dim lighting OTHER

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

Dim Lighting With Music; Dim Lighting Without Music

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baskent University Ankara Hospital: lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Urinary Incontinence; Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Mehmet Eflatun Deniz, MD

CONTACT

+905304079085; eflatun7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): September 7, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share