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

Lower Urinary Tract Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05948410
• Other study ID #: KocUrol3
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: July 2023
• Source: Koç University
• Contact: Tufan Tarcan, Prof
• Phone: 905434948365
• Email: bilgi[@]tufantarcan.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with an invasive urodynamic study indication

Exclusion Criteria:

• Non-Turkish speakers

• Poor conscious state

Related Conditions & MeSH terms

• Diagnosis
• Lower Urinary Tract Symptoms
• Mood Change

Intervention

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.
• 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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Koç University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The State-Trait Anxiety Inventory (STAI)	Questionnaire	1 week
Primary	Visual Analogue Scale	Questionnaire	1 week
Primary	Perceived Stress Scale	Questionnaire	1 week