NCT02009553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 12, 2013

Status Verified

December 1, 2013

Enrollment Period

11 months

First QC Date

December 2, 2013

Last Update Submit

December 9, 2013

Conditions

Anxiety

Keywords

AnxietyUrodynamics

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Information sheet, Applied

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

Other: Information sheet

Information sheet, not applied

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

Other: No information sheet

Interventions

Information sheetOTHER
Information sheet, Applied
No information sheetOTHER
Information sheet, not applied

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who will be designated to have multichannel Uridynamic study in our center.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofe Medical Center

Beer Yaakov, Zeriffin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Kobi Stav, MD

    Assaf Harofe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kobi Stav, MD

CONTACT

972-8-9778461stavkobi@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 12, 2013

Study Start

December 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

December 12, 2013

Record last verified: 2013-12

Locations

IL(1)