Interventions to Decrease Anxiety in Patients Undergoing Urodynamic Testing
Condition: Incontinence
Study type: Interventional

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.
    

Detailed description: 
      Research Design and Methods

      This study was a randomized controlled trial assessing the interventions of music, a patient
      educational video, or usual care pre-test teaching practice and anxiety before patients
      undergo urodynamic testing. This study enrolled women who were scheduled to undergo
      urodynamic testing within the Female Pelvic Medicine and Reconstructive Surgery clinic on
      main campus and at Fairview Hospital. Consenting participants were randomized to receive
      either usual practice pre-test teaching, usual practice pre-test teaching with soothing music
      in the background and throughout the test, or usual practice pre-test teaching and watching
      an educational video before the test was performed. The participants filled out a short
      questionnaire before urodynamic testing was started with two VAS scales assessing anxiety and
      pain and Likert Scale Questions, a second short questionnaire when the patient feels "strong
      urge" with two VAS scales assessing anxiety and pain, and a third questionnaire once the
      patient has completed the test again testing VAS anxiety and pain as well as some Likert
      scale questions.

      The primary outcome was to determine if pre-urodynamic testing anxiety was 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. Secondary outcomes were 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 were certain
      patients that would benefit from increased information.

      Enrollment All patients undergoing urodynamic testing for the first time who are over the age
      of 18 years old, female with presentation for urodynamics for urinary dysfunction, urinary
      incontinence, prolapse, or presurgical evaluation of voiding function were screened for
      participation in the study.

      Exclusion criteria included:

        1. Pregnancy

        2. Ongoing infections

        3. Inability to cooperate

        4. Inability to give consent

        5. Non-English speakers

        6. Patients who had undergone urodynamic testing in the past

      Randomization

      Random treatment assignments were placed in advance in set of sealed envelopes by a person
      who was not involved in opening the envelopes. Each envelope was numbered. When a patient was
      randomized, the patients name and the number of the next unopened envelope were recorded in a
      secure database. The envelope was then pened and the randomization was determined for the
      patient.

      Data Collection Protocol

      This study was incorporated into the patient's routine urodynamic testing. No additional
      visits were necessary.

      Demographic data including patient's age, ethnicity, education, catheter history, mental
      health history and medications were obtained, and patient satisfaction with care scores were
      also be collected. Paper forms will be stored in the locked research office at the Cleveland
      Clinic. Questionnaires were then collected in REDcap, a secure, web-based application
      designned to support data capture. We de-identified each patient and did not include their
      name or Cleveland Clinic medical record number on our data collection sheet form or on the
      questionnaires, or in the database. During abstraction, a separate log was kept with patient
      identifying information and linking it to the database in case it was necessary to go back to
      the medical record to clarify or complete data entry. This log will be destroyed after data
      collection is complete and before data analysis. The database was kept on a password
      protected Gynecology research drive accessible only by the study investigators.

        1. Patients randomized to the usual care arm woul have received mailings about urodynamic
           testing prior to arriving to the urodynamic suite. They then entered the urodynamic
           suite and the urodynamics provider discussed the information that was mailed to them.
           They also discussed the overall test, placement of catheters, and filling of the bladder
           with the patient before the provider began the test which is usual care. Once the
           provider finished giving the information, the patient filled out the first pre-test
           questionnaire which involved multiple Likert scale questions as well as Visual Analog
           Scale questions. During the urodynamic testing when the patient reached the point of
           "strong urge," a two question visual analog scale was given to the patient measuring
           anxiety and discomfort. Once the test has been concluded, the patient was given one
           further short post-test questionnaire using the Likert scale and Visual Analog Scale.

        2. Patients randomized to the video arm arrived to their appointment having received the
           mailed material (usual practice). Prior to watching the video, the patient was given the
           pre-test questionnaire. While in the urodynamics suite the patient watched a short
           patient informational video on urodynamics. Urodynamic testing was then performed and
           when the patient noted "strong urge"during the testing period, a short, two question
           visual analog scale questionnaire measuring anxiety and discomfort was given. Once the
           urodynamic testing was completed, the patient will fill out an additional Likert scale
           and Visual Analog Scale post-test questionnaire.

        3. Patients randomized to the music arm arrived to the appointment after having received
           mailed information about the test. The patient enter the urodynamics suite, was
           randomized and then slow music (tempo of 60 beats min) was started to play in the
           background. Usual practice instructions were given. The music continued through the
           urodynamic testing. Before the test and the usual practice instructions were given, the
           patient was given the pre-test questionnaire. When the patient notified the test
           provider that she had "strong urge" a second questionnaire with visual analog scales
           measuring anxiety and discomfort were given. Once the urodynamic testing was concluded,
           the patient was given the post-test questionnaire.
    

Intervention name(s): Music; Video; Standard of care
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): Subject listens to music that is 60bpm while undergoing urodynamic testing.; Subject watches an informational video prior to undergoing urodynamic testing.; Standard of care
Other intervention name(s): Music Therapy; Video therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Urodynamics, Anxiety