Impact of Verbal Compared to Structured Information on Patient's Anxiety and Satisfaction Undergoing Uroflowmetry
Phase: NA
Conditions: Anxiety, Satisfaction
Sponsor: Aga Khan University Hospital, Pakistan

Title:
Impact of verbal compared to structured information on patient’s anxiety and
satisfaction undergoing uroflowmetry
NCT- Number: Not yet allotted
Unique protocol ID (assigned by institutional IRB):
2023-8493-26340
Date: 29/6/2025
Primary Investigator:
Dr. Ramna Nadeem, resident year 3 (PGY 5), Urology, Aga Khan University
Hospital (ramna.nadeem@aku.edu)
Co-investigator:
Dr. Muhammad Hammad Ather, Professor of Urology, Department of Surgery,
Aga Khan University Hospital. (hammad.ather@aku.edu)
Dr. Nuzhat Faruqui, Assistant Professor, Surgery, Aga Khan University Hospital.
(nuzhat.faruqui@aku.edu)
STATEMENT OF COMPLIANCE:
This study complies with the Good Clinical Practice (GCP) Guidelines.

Introduction:
Lower urinary tract symptoms (LUTS) significantly impact approximately half of
men and women aged >40 years. (1) This entity includes storage/overactive
bladder symptoms, voiding, and post-micturition symptoms. (2) Burden of this
condition is increased from 18.4 to 45.8% in a few decades. (2) This condition has
multifactorial etiologies and has a significant impact on quality of life, public
health costs, and economic burden. (2, 3)
Uroflowmetry (UFM) is a non-invasive initial, simple, and widely performed first-
line investigation for the evaluation of this condition. (4) This investigation is an
objective assessment of the patient’s symptoms and can also be used to follow the
response of treatment on lower urinary tract symptoms. (4) Literature has shown
that to obtain true representative results patients should be comfortable. (1) Few
studies have identified factors having an impact on the satisfaction of patients
undergoing uroflowmetry. Khavari et al.,2016 in his study found that trained and
dedicated staff improves patient satisfaction. (5)
Even though non-invasive nature, this investigation can lead to emotional
disturbance and anxiety with a reported prevalence of up to 41.3%. (4) Limited
literature is reported regarding the relationship between anxiety and patient
satisfaction undergoing uroflowmetry with a lack of validated questionnaires in
assessing the impact of non-invasive urological tests on these aspects. In our study,
to assess anxiety in patients undergoing uroflowmetry modified Amsterdam
Preoperative Anxiety and Information Scale (APAIS-M) will be used as according
to Rubilotta et al.,2020 this tool can provide reliable results. (4) To assess
satisfaction Dogun et al., 2022 developed and used a patient satisfaction form. This
patient satisfaction form will be used in our study. (1)
This study is an initial step in highlighting the significance of different methods of
counseling and will help in the future to provide effective means of education
which will help in obtaining representative pattern of patient.
Rationale:
With the rising burden of LUTS and the utilization of UFM in its evaluation,
improvement in its utilization is critical. The result of UFM is influenced by
psychological discomfort. Therefore, psychological discomfort has to be
minimized during performance of uroflowmetry to obtain a routine pattern of
UFM. In our study psychological discomfort includes anxiety and satisfaction.

This study aims to identify the impact on psychological discomfort after giving
structured education and compare it with a group of patients routinely counseled
verbally by health care providers which will help in future to improvise counseling
method.
Primary Objective
1. To compare the level of anxiety by modified APAIS score in patients
undergoing UFM who receive structured versus verbal education.
2. To compare patient satisfaction by patient satisfaction form after UFM in the
two groups.
Secondary Objective:
1. To determine length of stay in both samples
Hypothesis:
Alternate hypothesis:
There is a difference in anxiety and satisfaction in patients receiving structured
versus verbal education.
Null hypothesis:
There is no difference in anxiety and satisfaction in patients receiving structured
versus verbal education.
Operational definitions:
Anxiety:
In the ICD-10 code anxiety is defined as anxious feelings or fear. In our study,
modified Amsterdam Preoperative Anxiety and Information Scale (APAIS-M) will
be used to assess the level of anxiety as to date there is no validated tool available
to assess anxiety in patients undergoing uroflowmetry. This modified version of
APAIS was obtained from a previous study conducted in patients undergoing
uroflowmetry. This part of the questionnaire will be filled just after providing
education and before performing uroflowmetry.
The score for this tool will minimum be 3 and a maximum be 15 and results will be
categorized into three groups; (4)
3-6 no anxiety, 7-10 moderate anxiety, 11-15 severe anxiety (4)

Patient satisfaction:
It is an objective assessment of patient satisfaction with provided knowledge by the
health care provider. (6) 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. (1)
Verbal education:
It will include verbal counseling given by a healthcare provider.
Structured education:
It will include a printed brochure having procedural details of uroflowmetry
designed by our institute after assessment through the Patient Educational Material
Assessment Tool (PEMAT). This will be provided to patients along with video
briefing procedural details.
Length of stay:
This duration will be calculated from the time of registration till the printed report
of a graph.
Adequate uroflowmetry: It includes the minimum voided volume of 150 ml.
Methodology:
Study Design: Parallel arm study design-Single blind study
Setting: Section of urology at the Aga Khan University Hospital, Karachi,
Pakistan.
Study Duration: Data will be collected after DRC and ERC approval from July
10th June 2025 or till sample size achieved.
Study population: Patients visiting the urology suite at Aga Khan University
Hospital Karachi.
Sampling technique: Simple random technique/ Non probability purposive
sampling
Sample: All those patients who require a UFM test and fulfilling the inclusion
criteria will be invited to participate in this study.

After approval from DRC and ERC Questionnaire will be sent to 5 experts (both
English and Urdu version) and based on their responses content validity index will
be recorded. The score of more than and equal to 0.8 is considered acceptable and
then the study will be started.
Patients will be assigned to a group using sealed envelope system. In this system,
once patient has consented to enter a trial an envelope is opened and the patient
will then inducted in the allocated group. Patient inducted in control group will be
called from Thursday till Saturday for uroflowmetry and those inducted in
intervention group will be called from Monday till Wednesday for uroflowmetry to
prevent contamination.
Inclusion criteria:
1) Age 18 years and above
2) Undergoing uroflowmetry for the first time
3) Patients, who can hear, read and comprehend the education in either Urdu or
English language.
Exclusion criteria:
1) Language barrier
2) Known psychiatric illness
3) Unable to comprehend instructions due to any neurological issue
4) Unable to void adequate volume even after 3 attempts
Randomization:
In this study, patients will be assigned to a group using sealed envelope system. In
this system, once patient has consented to enter a trial an envelope is opened and
the patient will then be inducted in the allocated group. Patient inducted in control
group will be called from Thursday till Saturday for verbal counselling and
uroflowmetry and those inducted in intervention group will be called from Monday
till Wednesday for structured counselling and uroflowmetry to prevent
contamination. This randomization method is done by principal investigator or co-
investigators.
All registered patients will be counselled verbally (in the control group) or through
brochures and video (in the intervention group). After counseling first and second
part of the proforma (basic demographics and anxiety score) will be filled before
performing uroflowmetry and then once uroflowmetry is performed, the third part
(satisfaction score) will be filled. All this assessment will take approx. 20-25
minutes.

The interim analysis will be done and if results are going towards any extreme or if
patients are getting any unexpected harm, following the stopping rule the study
will be stopped and will conclude results.
To minimize bias, single blinding will be done and data analysts will be kept blind
and data will be stored in coded form.
Data collection strategy:
Control Group (Verbally counseled):
As per hospital routine, all patients undergoing UFM procedures will be educated
verbally about the procedure. There will be no difference in care level.
After counselling first and second part of the proforma (Appendix 3 and 4) (basic
demographics and anxiety score) will be filled and then once uroflowmetry is
performed, the third part (satisfaction score) will be filled All this assessment will
take approx. 20-25 minutes.
Intervention Group (Counselled with structured education):
As per new practice, all patients undergoing UFM will be educated through
structured educational material provided in the brochure (Appendix 5) along with a
video tutorial briefing details of uroflowmetry. There will be no difference in care
level.
After counseling first and second part of the proforma (basic demographics and
anxiety score) will be filled and then once uroflowmetry is performed, the third
part (satisfaction score) (Appendix 3 and 4)will be filled. All this assessment will
take approx 20-25 minutes.
Measures to minimize bias:
To minimize bias baseline characters of both groups will be kept similar. Groups
will be divided into two equal numbers of participants on basis of morning and
afternoon shifts to minimize contamination. Single blinding will be done and data
analysts will be kept blind and data will be stored in coded form.
Sample size:
The sample size was calculated on open epi software version 3.01. A sample size
of 132 is calculated in total with 66+/-7 in each group; with an anticipated mean
and SD of 19.1+/-3.4 in group 1, 22.4+/-2.7 in group 2, and considering the
difference of 1.5 (1); and with a level of significance of 5%, power of 80% and
ratio of sample size 1:1. This is calculated by using available literature of second
objective as no values are available for first objective.
The strength of our study would be that both groups will be equal.

Statistical methods:
To minimize bias, single blinding will be done and data analysts will be kept blind
and data will be stored in coded form.
Data will be analyzed on SPSS window 22.0 (SPSS Inc. Chicago). Descriptive
statistics for quantitative variables such as age, patient satisfaction, and length of
stay will be reported as mean and standard deviation/ median (IQR). Frequencies
and percentages will be reported for anxiety. The normality of continuous data will
be determined by applying the Shapiro-Wilk test. The independent t-test/ Man
Whitney test will be used to determine statistically significant differences for the
mean and standard deviation of two groups (verbally counseled and counseled with
structured education) for quantitative variables including age, patient satisfaction
and length of stay and the Chi-square/Fisher test will be used for categorical
variables calculated in percentages and frequencies including anxiety. The
association between counseling done by verbal and structured education with
anxiety and patient satisfaction will be checked by multivariable analysis and crude
and adjusted odds ratio with a 95% confidence interval will be reported. A p-value
of <0.05 will be considered significant.
Limitations:
In our study, limitations will be its single-center study and lack of a validated
questionnaire to assess patient satisfaction as this score is obtained from the
previous study.
ETHICAL CONSIDERATIONS:
This trial will be conducted in compliance with the principles of the Declaration of
Helsinki, the principles of Good Clinical Practice (GCP), and all of the applicable
regulatory requirements.
In this study, after taking approval from DRC and ERC data collection will be
started. After getting informed consent in provided English/Urdu language as per
patient preference, we will be collecting data including demographics, anxiety
assessment, and patient satisfaction in both groups (receiving verbal or structured
education) from patients visiting the urology clinic and undergoing uroflowmetry.
Data will be collected in a separate room for privacy. Data will be kept in lockers
and will be secured by the investigators and it will only be accessible to primary
investigator and co-investigator. Patient confidentiality will be maintained using a
specific code for each patient.
Reporting and recording procedures of adverse events:

There will be no adverse events anticipated. Though during our assessment if the
patient is found to be anxious, a referral letter for an appropriate
psychologist/psychiatrist will be provided for support and further evaluation.
References:
1.
Dogan S. Comparison of Self-Conducted and Assistant-Supervised Uroflowmetry Methods.
Cureus. 2022;14(2):e22030.
2.
Zhang AY, Xu X. Prevalence, burden, and treatment of lower urinary tract symptoms in men
aged 50 and older: a systematic review of the literature. SAGE Open Nursing.
2018;4:2377960818811773.
3.
Dawidek MT, Singla R, Spooner L, Ho L, Nguan C. Clinical validation of an audio-based
uroflowmetry application in adult males. Canadian Urological Association journal = Journal de
l'Association des urologues du Canada. 2022;16(3):E120-e5.
4.
Rubilotta E, Balzarro M, Castellani D, Tiso L, Panunzio A, Pirola GM, et al. The Role of Emotional
Condition in Patients With Lower Urinary Tract Symptoms Performing Uroflowmetry. Urology.
2021;148:37-46.
5.
Khavari R, Gu C, Tran AC, Chan R. Trained and dedicated staff appears to be the main factor in
decreasing anxiety and improving overall satisfaction during urodynamic testing: A prospective,
randomized trial. Canadian Urological Association Journal. 2016;10(5-6):187.
6.
Manzoor F, Wei L, Hussain A, Asif M, Shah SIA. Patient Satisfaction with Health Care Services; An
Application of Physician's Behavior as a Moderator. International journal of environmental research and
public health. 2019;16(18).