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

• Conditions: Anxiety
• Interventions: Other: No information sheet; Other: Information sheet

• Registration Number: NCT02009553
• Lead Sponsor: Assaf-Harofeh Medical Center

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.

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-09
• Last Update Submitted: 2013-12-09
• Study First Posted: 2013-12-12
• Last Update Posted: 2013-12-12
• Primary Completion: 2014-11
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

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

Exclusion Criteria

1. inability to complete the questionnaire due to mental disorders
2. patients who had undergone Urodynamic study previously

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Information sheet, not applied	No information sheet	In this group, patients will not receive a pre-procedural information sheet
Information sheet, Applied	Information sheet	In this group, all patients will receive the information sheet one month before the procedure

Primary Outcome Measures

Name	Time	Method
State Anxiety Inventory	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.

Trial Locations

Locations (1)

Assaf Harofe Medical Center; 🇮🇱 Beer Yaakov, Zeriffin, Israel