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Interventions to Decrease Anxiety in Patients Undergoing Urodynamic Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168556
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
This is a randomized controlled trial to determine if music, a video, or standard of care will decrease anxiety in patients undergoing urodynamic testing.

Condition or disease Intervention/treatment Phase
Incontinence Behavioral: Music Behavioral: Video Other: Standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.
Behavioral: Music
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.
Behavioral: Video
Subject watches an informational video prior to undergoing urodynamic testing.
Other Name: Video therapy




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years old and above,
  • female
  • urinary dysfunction
  • urinary incontinence
  • prolapse
  • presurgical evaluation of voiding function
  • Never undergone Urodynamics before

Exclusion Criteria:

  • Pregnancy
  • Ongoing urinary tract infections
  • Inability to cooperate
  • Inability to give consent
  • Non-English speakers
  • Patients who have undergone urodynamic testing in the past

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Ellen R Solomon, MD The Cleveland Clinic
Principal Investigator: Beri Ridgeway, MD The Cleveland Clinic
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02168556    
Other Study ID Numbers: 12-1351
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by The Cleveland Clinic:
Urodynamics, Anxiety
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders