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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02009553
• Other study ID #: 167/13
• Secondary ID: 167/13
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2013
• Last updated: December 9, 2013
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Assaf-Harofeh Medical Center
• Contact: Kobi Stav, MD
• Phone: 972-8-9778461
• Email: stavkobi[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Other:
• Information sheet

• No information sheet

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center	Beer Yaakov	Zeriffin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State Anxiety Inventory	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.	10 minutes before the test	No