How Does the Mood of the Patients Change Before and After the Invasive Urodynamic Study?
Sponsor
Koç University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05948410
Collaborator
(none)
50
15
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
How Does the Mood of the Patients Change Before and After the Invasive Urodynamic Study?
Anticipated Study Start Date
:
Oct 1, 2023
Anticipated Primary Completion Date
:
Oct 1, 2024
Anticipated Study Completion Date
:
Jan 1, 2025
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- The State-Trait Anxiety Inventory (STAI) [1 week]
Questionnaire
- Visual Analogue Scale [1 week]
Questionnaire
- Perceived Stress Scale [1 week]
Questionnaire
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients with an invasive urodynamic study indication
Exclusion Criteria:
-
Non-Turkish speakers
-
Poor conscious state
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Koç University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ersin Köseoglu,
MD,
Koç University
ClinicalTrials.gov Identifier:
NCT05948410
Other Study ID Numbers:
- KocUrol3
First Posted:
Jul 17, 2023
Last Update Posted:
Jul 17, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ersin Köseoglu,
MD,
Koç University
Additional relevant MeSH terms: