Interventions to Decrease Anxiety in Patients Undergoing Urodynamic Testing
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|ClinicalTrials.gov Identifier: NCT02168556|
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : June 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Incontinence||Behavioral: Music Behavioral: Video Other: Standard of care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Interventions to Decrease Anxiety in Patients Undergoing Urodynamic Testing|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Placebo Comparator: Standard of Care
Patient underwent urodynamic testing by receiving only standard of care with mailed information and during test teaching.
Other: Standard of care
Standard of care
Active Comparator: Music
Patient underwent urodynamic testing while listening to music that was 60 beats per minute and received standard of care information and teaching.
Subject listens to music that is 60bpm while undergoing urodynamic testing.
Other Name: Music Therapy
Active Comparator: Video
Patient watched an informational video prior to urodynamic testing.
Subject watches an informational video prior to undergoing urodynamic testing.
Other Name: Video therapy
- Anxiety [ Time Frame: One day ]The primary outcome is to determine if pre-urodynamic testing anxiety is decreased after watching a pre-test educational video, or by listening to music before and throughout the procedure, or by receiving standard of care pre-test teaching. For measurement of anxiety we used 100mm Visual analog scales. We used a questionnaire to obtain demographics. We used a five point Likert scale to ask questions about their use of the internet and information seeking behavior.
- Discomfort [ Time Frame: One Day ]Secondary outcomes are to determine baseline anxiety in our urodynamic patient population and to determine if there is decreased discomfort due to the intervention as well as to evaluate if there are certain patients that would benefit from increased information. For measurement of discomfort we used 100mm Visual analog scales. We used a questionnaire to obtain demographics. We used a five point Likert scale to ask questions about their use of the internet and information seeking behavior.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168556
|United States, Ohio|
|Cleveland, Ohio, United States, 44111|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Ellen R Solomon, MD||The Cleveland Clinic|
|Principal Investigator:||Beri Ridgeway, MD||The Cleveland Clinic|