Interventions to Decrease Anxiety in Patients Undergoing Urodynamic Testing
1 other identifier
interventional
98
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 27, 2014
CompletedFirst Posted
Study publicly available on registry
June 20, 2014
CompletedJune 23, 2014
June 1, 2014
11 months
May 27, 2014
June 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anxiety
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.
One day
Secondary Outcomes (1)
Discomfort
One Day
Study Arms (3)
Standard of Care
PLACEBO COMPARATORPatient underwent urodynamic testing by receiving only standard of care with mailed information and during test teaching.
Music
ACTIVE COMPARATORPatient underwent urodynamic testing while listening to music that was 60 beats per minute and received standard of care information and teaching.
Video
ACTIVE COMPARATORPatient watched an informational video prior to urodynamic testing.
Interventions
Eligibility Criteria
You may qualify if:
- years old and above,
- female
- urinary dysfunction
- urinary incontinence
- prolapse
- presurgical evaluation of voiding function
- Never undergone Urodynamics before
You may not qualify if:
- Pregnancy
- Ongoing urinary tract infections
- Inability to cooperate
- Inability to give consent
- Non-English speakers
- Patients who have undergone urodynamic testing in the past
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Related Publications (1)
Solomon ER, Ridgeway B. Interventions to decrease pain and anxiety in patients undergoing urodynamic testing: A randomized controlled trial. Neurourol Urodyn. 2016 Nov;35(8):975-979. doi: 10.1002/nau.22840. Epub 2015 Jul 30.
PMID: 26227401DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ellen R Solomon, MD
The Cleveland Clinic
- PRINCIPAL INVESTIGATOR
Beri Ridgeway, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2014
First Posted
June 20, 2014
Study Start
June 1, 2013
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
June 23, 2014
Record last verified: 2014-06