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

NCT ID: NCT02009553

Last Updated: 2013-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Anxiety

Keywords

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Anxiety Urodynamics

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Information sheet, Applied

In this group, all patients will receive the information sheet one month before the procedure

Information sheet

Intervention Type OTHER

Information sheet, not applied

In this group, patients will not receive a pre-procedural information sheet

No information sheet

Intervention Type OTHER

Interventions

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Information sheet

Intervention Type OTHER

No information sheet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kobi Stav, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofe Medical Center

Locations

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Assaf Harofe Medical Center

Beer Yaakov, Zeriffin, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Kobi Stav, MD

Role: CONTACT

Phone: 972-8-9778461

Email: [email protected]

Facility Contacts

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Kobi Stav, MD

Role: primary

Other Identifiers

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167/13

Identifier Type: OTHER

Identifier Source: secondary_id

167/13

Identifier Type: -

Identifier Source: org_study_id