Impact of Verbal Compared to Structured Information on Patient's Anxiety and Satisfaction Undergoing Uroflowmetry

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAga Khan University Hospital, Pakistan

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Structured education group

    Other intervention

    Structured education group

Treatment groups

132 Participants
are divided into 2 treatment groups
Group A: Structured education groupExperimental treatment 1 intervention
Group B: Verbally counselled groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Will be assessed immediately after counselling by either verbal or structured education in peri investigation period.
2

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.

Time frame
Will be assessed immediately after performing uroflowmetry test (post investigation period) in both groups receiving counselling either through verbal or structured education.

Secondary outcomes

Other outcomes

Sponsors and contacts

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