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

NCT07056192 | Recruiting DMC

• 1 other identifier: 2023-8493-26340
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Satisfaction

Keywords

Uroflowmetry; Anxiety; Verbal education; Structured information; Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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.

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

Study Arms (2)

Structured education group

EXPERIMENTAL

Structurally counselled group

Other: Structured education group

Verbally counselled group

NO INTERVENTION

Verbally counselled group

Interventions

Structured education group OTHER

Structured education group

Structured education group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Language barrier
• Known psychiatric illness
• Unable to comprehend instructions due to any neurological issue
• Unable to void adequate volume even after 3 attempts

Sponsors & Collaborators

• Aga Khan University Hospital, Pakistan: lead

Study Sites (1)

Aga khan university hospital

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related Publications (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. Int J Environ Res Public Health. 2019 Sep 9;16(18):3318. doi: 10.3390/ijerph16183318.

  PMID: 31505840 BACKGROUND

• 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. Can Urol Assoc J. 2016 May-Jun;10(5-6):187-190. doi: 10.5489/cuaj.3421.

  PMID: 27713797 BACKGROUND

• Rubilotta E, Balzarro M, Castellani D, Tiso L, Panunzio A, Pirola GM, Antonelli A, Giannantoni A, Gubbiotti M. The Role of Emotional Condition in Patients With Lower Urinary Tract Symptoms Performing Uroflowmetry. Urology. 2021 Feb;148:37-46. doi: 10.1016/j.urology.2020.10.045. Epub 2020 Nov 17.

  PMID: 33217454 BACKGROUND

• Dawidek MT, Singla R, Spooner L, Ho L, Nguan C. Clinical validation of an audio-based uroflowmetry application in adult males. Can Urol Assoc J. 2022 Mar;16(3):E120-E125. doi: 10.5489/cuaj.7362.

  PMID: 34672935 BACKGROUND

• 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 Nurs. 2018 Dec 26;4:2377960818811773. doi: 10.1177/2377960818811773. eCollection 2018 Jan-Dec.

  PMID: 33415211 BACKGROUND

• Dogan S. Comparison of Self-Conducted and Assistant-Supervised Uroflowmetry Methods. Cureus. 2022 Feb 8;14(2):e22030. doi: 10.7759/cureus.22030. eCollection 2022 Feb.

  PMID: 35282527 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Ramna Nadeem, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramna Nadeem, FCPS

CONTACT

+92-3218095545; ramna.nadeem16@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident/ Trainee in Urology department (Principal investigator))

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 9, 2025
• Study Start: January 1, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)