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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02009553
Enrollment
104
Registered
2013-12-12
Start date
2013-12-31
Completion date
2014-12-31
Last updated
2013-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Anxiety, Urodynamics

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.

Interventions

OTHERNo information sheet

Sponsors

Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
State Anxiety Inventory10 minutes before the testInvestigators 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.

Countries

Israel

Contacts

Primary ContactKobi Stav, MD
stavkobi@gmail.com972-8-9778461

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026