About this trial
Background: Uroflowmetry (UFM) is a non-invasive initial, simple, and widely performed first-line investigation for the evaluation of lower urinary tract symptoms. Despite its non-invasive nature, uroflowmetry can provoke anxiety and affect satisfaction, often due to misunderstandings about the procedure.
Objective: This randomized control trial aimed to compare the effects of structured versus verbal education on anxiety and satisfaction in patients undergoing uroflowmetry.
Methodology: A single-blind, parallel-arm study will include 48 patients, which will be randomized into structured (brochure) and verbal counseling groups. The modified Amsterdam Preoperative Anxiety and Information Scale (APAIS-M) will assess anxiety, while satisfaction will be measured by using a questionnaire adapted from Dogun et al. Descriptive statistics, Chi-square, and independent t-tests will be employed for data analysis in spss 23.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years and above
Undergoing uroflowmetry for the first time
Patients, who can hear, read and comprehend the education in either Urdu or English language.
Disqualifiers
Language barrier
Known psychiatric illness
Unable to comprehend instructions due to any neurological issue
Unable to void adequate volume even after 3 attempts
Trial design
Parallel
Treatments tested in this trial
Structured education group
Other interventionStructured education group
Treatment groups
Trial outcomes
Primary outcomes
Comparison of level of anxiety using modified Amsterdam Preoperative Anxiety and Information Scale (APAIS-M) in both groups receiving verbal or structured education
Assess level of anxiety by APAIS-M. The score for this tool will minimum be 3 and a maximum be 15 and results will be categorized into three groups; 3-6 no anxiety, 7-10 moderate anxiety, 11-15 severe anxiety
To compare patient satisfaction by patient satisfaction form after uroflowmtery
It is an objective assessment of patient satisfaction with provided knowledge by the health care provider. This tool is taken from a study published in 2022 as there is no validated questionnaire available to date to assess satisfaction in patients undergoing uroflowmetry.
Sponsors and contacts
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