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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Study population: Patients with an indication of invasive urodynamic study

Trial locations and contacts

No sites are listed yet.

About this study

Conditions

Lower Urinary Tract Symptoms, Mood Change, Diagnosis

Being tested

The State-Trait Anxiety Inventory (STAI), Perceived Stress Scale, Visual Analog Scale

Keywords

invasive urodynamic study, mood

Medical subject headings

Lower Urinary Tract Symptoms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• The State-Trait Anxiety Inventory (STAI)Behavioural

  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 ScaleBehavioural

  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 ScaleBehavioural

  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 being measured

The primary outcome is the main question the study is designed to answer.

1. The State-Trait Anxiety Inventory (STAI)

   Questionnaire

   Measured: 1 week

2. Visual Analogue Scale

   Questionnaire

   Measured: 1 week

3. Perceived Stress Scale

   Questionnaire

   Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted17 Jul 2023
2. Study start1 Oct 2023 (estimated)
3. Primary completion1 Oct 2024 (estimated)
4. Study completion1 Jan 2025 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.