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Clinical Trials/NCT02009553
NCT02009553
Unknown
Not Applicable

Pre-procedural Information Sheet Reduces Anxiety of Patients Before Urodynamic Studies

Assaf-Harofeh Medical Center1 site in 1 country104 target enrollmentDecember 2013
ConditionsAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
Assaf-Harofeh Medical Center
Enrollment
104
Locations
1
Primary Endpoint
State Anxiety Inventory
Last Updated
12 years ago

Overview

Brief Summary

Urodynamic study may lead to significant anxiety. Our hypothesis is that Urodynamic study is that pre-procedural explanation note about the test may reduce the anxiety level of the patients.

Detailed Description

Urodynamic study is one of the most common procedures in urological outpatient practice. Patients who wait for the tests may experience significant anxiety. in this study, patients who are designated to have multichannel Urodynamic study will be randomized to two groups: group 1 - patients who received an explanation note about the test; group 2 - patients who did not receive the note. The explanation notes will be sent to the patients in group 1 by mail one month before the test. Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress immediately before the test. Comparison opf the anxiety level between the two groups will be performed.

Registry
clinicaltrials.gov
Start Date
December 2013
End Date
December 2014
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All patients who will be referred for Urodynamic studies in order to evaluate lower urinary tract symptoms.

Exclusion Criteria

  • inability to complete the questionnaire due to mental disorders
  • patients who had undergone Urodynamic study previously

Outcomes

Primary Outcomes

State Anxiety Inventory

Time Frame: 10 minutes before the test

Investigators will use the State Anxiety Inventory (SAI) in order to assess emotional distress. The SAI is a validated questionnaire composed of 20-items measures of anxiety (e.g. ''I am anxious''). Respondents will be requested to rate their endorsement of each item on a four-point scale.

Study Sites (1)

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