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Not yet recruitingNCT05948410Updated Jul 17, 2023

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

An observational study in Lower Urinary Tract Symptoms, Mood Change and Diagnosis, sponsored by Koç University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-17.

Sponsored by Koç University · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Lower Urinary Tract Symptoms
  • Mood Change
  • Diagnosis

Keywords

  • invasive urodynamic study
  • mood
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In context

Lower Urinary Tract Symptoms

406 studies on the registry are indexed under Lower Urinary Tract Symptoms; 110 are open to participants now.

This study's planned enrollment of 50 is below the median of 179 across 132 observational studies indexed under Lower Urinary Tract Symptoms.

Browse Lower Urinary Tract Symptoms studies →

Lead sponsor

Koç University is the lead sponsor of 106 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with an indication of invasive urodynamic study

Inclusion criteria

  • Patients with an invasive urodynamic study indication

Exclusion criteria

Exclusion Criteria:

  • Non-Turkish speakers
  • Poor conscious state
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes

Groups and cohorts

  • 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

  • BehavioralThe 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.

  • BehavioralPerceived 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

  • BehavioralVisual 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.

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What researchers measure

Primary outcomes

  1. The State-Trait Anxiety Inventory (STAI)

    Questionnaire

    Time frame: 1 week

  2. Visual Analogue Scale

    Questionnaire

    Time frame: 1 week

  3. Perceived Stress Scale

    Questionnaire

    Time frame: 1 week

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05948410
Lead sponsor
Koç University
Responsible party
Ersin Köseoglu (MD, Koç University) — Principal investigator
First posted
Jul 17, 2023
Start date
Oct 1, 2023 (estimated)
Primary completion
Oct 1, 2024 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
Jul 17, 2023

Study contacts

Tufan Tarcan, Prof
Contact
bilgi@tufantarcan.com
905434948365
Ersin Köseoğlu
Contact
ersinkoseoglu@ku.edu.tr
905306930442

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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