How Does the Mood of the Patients Change Before and After the Invasive Urodynamic Study?

The goal of this study is to learn about the patient's perspective regarding to psychological mood before and after an invasive urodynamic study.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Urinary Tract Symptoms; Diagnosis; Mood Change
• Intervention / Treatment: Behavioral: The State-Trait Anxiety Inventory (STAI); Behavioral: Perceived Stress Scale; Behavioral: Visual Analog Scale

Detailed Description

The participants have already had an indication of an invasive urodynamic study. All patients will be given STAI, perceived stress scale and VAS forms just before, after and 1-week following an invasive urodynamic study. The scores will be compared.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Tufan Tarcan, Prof; Phone Number: 905434948365; Email: bilgi@tufantarcan.com
• Study Contact Backup: Name: Ersin Köseoğlu; Phone Number: 905306930442; Email: ersinkoseoglu@ku.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication of invasive urodynamic study

Description

Inclusion Criteria:

• Patients with an invasive urodynamic study indication

Exclusion Criteria:

• Non-Turkish speakers
• Poor conscious state

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study Group; Patients with an indication of invasive urodynamic study

Behavioral: The State-Trait Anxiety Inventory (STAI); The State-Trait Anxiety Inventory (STAI) is a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. Higher scores are positively correlated with higher levels of anxiety.; Behavioral: Perceived Stress Scale; The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. A short 4 item scale can be made from questions 2, 4, 5 and 10 of the PSS 10 item scale; Behavioral: Visual Analog Scale; The visual analogue scale (VAS) is a psychometric response scale that can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The State-Trait Anxiety Inventory (STAI)	Questionnaire	1 week
Visual Analogue Scale	Questionnaire	1 week
Perceived Stress Scale	Questionnaire	1 week

Collaborators and Investigators

• Sponsor: Koç University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: July 9, 2023
• First Submitted That Met QC Criteria: July 9, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: mood; invasive urodynamic study
• Additional Relevant MeSH Terms: Urological Manifestations; Lower Urinary Tract Symptoms
• Other Study ID Numbers: KocUrol3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No