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

NCT05948410 | Unknown

• 1 other identifier: KocUrol3
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lower Urinary Tract Symptoms; Mood Change; Diagnosis

Keywords

invasive urodynamic study; mood

Outcome Measures

Primary Outcomes (3)

• The State-Trait Anxiety Inventory (STAI)

  Questionnaire

  1 week

• Visual Analogue Scale

  Questionnaire

  1 week

• Perceived Stress Scale

  Questionnaire

  1 week

Study Arms (1)

Study Group

Patients with an indication of invasive urodynamic study

Behavioral: The State-Trait Anxiety Inventory (STAI); Behavioral: Perceived Stress Scale; Behavioral: Visual Analog Scale

Interventions

The State-Trait Anxiety Inventory (STAI) BEHAVIORAL

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.

Study Group

Perceived Stress Scale BEHAVIORAL

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

Study Group

Visual Analog Scale BEHAVIORAL

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.

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication of invasive urodynamic study

You may qualify if:

• Patients with an invasive urodynamic study indication

You may not qualify if:

• Non-Turkish speakers
• Poor conscious state

Sponsors & Collaborators

• Koç University: lead

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Disease

Interventions

Perceived Stress Scale

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Central Study Contacts

Tufan Tarcan, Prof

CONTACT

905434948365; bilgi@tufantarcan.com

Ersin Köseoğlu

CONTACT

905306930442; ersinkoseoglu@ku.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 17, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share