- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06687538
Effect of Education to be Provided to Patients to Undergo TURP With Mobile Application on Patient Outcomes
June 7, 2026 updated by: Gamze BOZKUL, Tarsus University
The Effect of Education to be Provided to Patients to Undergo Prostate Surgery With Mobile Application on Patient Outcomes
The aim of this study was to determine the effect of mobile application training on patient outcomes (preoperative anxiety, surgical fear, postoperative pain, hemodynamic parameters, satisfaction level and length of hospital stay) in patients undergoing transurethral prostate resection surgery.
It was planned as a prospective, two-arm (1:1), randomized controlled clinical trial.
The study will be conducted with 68 patients in the urology clinic of a vir university hospital.
Patients will be randomly assigned to the control group and the mobile application training group.
Patients in the mobile application group will be trained with the mobile application, while patients in the control group will only receive routine care in the clinic.
Patients assigned to the mobile application group will be introduced to the education to be given with the mobile application and the application will be downloaded to their phones/tablets.
Data will be collected with the Introductory Information Form, Visual Comparison Scale, State Anxiety Scale, Hemodynamic Parameters Monitoring Form, Surgical Fear Scale and Education Satisfaction Scale.
When the patient is admitted to the clinic, "Introductory Information Form", "State Anxiety Scale", and "Surgical Fear Scale" will be applied to the patients in the mobile intervention and control groups before surgical intervention, and "Hemodynamic Parameters Monitoring Form" will be completed.
After the surgical intervention, "Visual Comparison Scale" and "Education Satisfaction Scale" will be applied to all patients and "Hemodynamic Parameters Monitoring Form" will be completed.
The data will be analyzed in a computer environment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of this study was to determine the effect of mobile application training on patient outcomes (preoperative anxiety, surgical fear, postoperative pain, hemodynamic parameters, satisfaction level and length of hospital stay) in patients undergoing transurethral prostate resection surgery.
It was planned as a prospective, two-arm (1:1), randomized controlled clinical trial.
The study will be conducted with 68 patients in the urology clinic of a vir university hospital.
Patients will be randomly assigned to the control group and the mobile application training group.
Patients in the mobile application group will be trained with the mobile application, while patients in the control group will only receive routine care in the clinic.
Patients assigned to the mobile application group will be introduced to the education to be given with the mobile application and the application will be downloaded to their phones/tablets.
Data will be collected with the Introductory Information Form, Visual Comparison Scale, State Anxiety Scale, Hemodynamic Parameters Monitoring Form, Surgical Fear Scale and Education Satisfaction Scale.
When the patient is admitted to the clinic, "Introductory Information Form", "State Anxiety Scale", and "Surgical Fear Scale" will be applied to the patients in the mobile intervention and control groups before surgical intervention, and "Hemodynamic Parameters Monitoring Form" will be completed.
After the surgical intervention, "Visual Comparison Scale" and "Education Satisfaction Scale" will be applied to all patients and "Hemodynamic Parameters Monitoring Form" will be completed.
The data will be analyzed in a computer environment.
The suitability of the data for normal distribution will be evaluated by Shaphiro Wilk Test.
For continuous variables with normal distribution, t-test in independent groups will be used to compare two independent group averages; Mann-Whitney U test will be used to compare continuous variables that do not show normal distribution.
Statistical significance value will be taken as p<0.05.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Turkey
-
Mersin, Turkey, Turkey (Türkiye), 33400
- Tarsus University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years of age or older,
- Written permission to participate in the study,
- Conscious, oriented and cooperative,
- Speaks and understands Turkish,
- Literate,
- Undergoing TURP,
- No vision problems,
- Patients who or their caregivers have a phone/tablet with the ability to download mobile training
Exclusion Criteria:
- Undergoing TURP for the second time,
- Physically or mentally ill with a physical or mental illness that prevents communication,
- Underwent day surgery,
- Neither they nor their caregivers have a phone/tablet with the ability to download mobile training patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile application group
When the executive (EP) goes to the patient for the procedure, he/she will fill out the "Informed Consent Form", open the envelope and find out which group the patient is in.
"Introductory Information Form", 'State Anxiety Scale', 'Hemodynamic Variables Monitoring Form' and 'Surgical Fear Scale' will be completed for all patients undergoing TURP.
Patients in the study group will be introduced to the training to be given with the mobile application and downloaded to their phones/tablets.
According to randomization, patients in the study group will receive training with the mobile application and patients in the control group will receive routine care.
In the postoperative period, "Hemodynamic Variables Monitoring Form", "Visual Analog Scale" and "Education Satisfaction Scale" will be completed for all patients.
|
The content of the mobile application training to be developed for patients who will undergo transurethral prostate resection will consist of 3 modules including preoperative, postoperative and discharge training process.
|
|
No Intervention: Control group
When the executive (EP) goes to the patient for the procedure, he/she will fill out the "Informed Consent Form", open the envelope and find out which group the patient is in.
"Introductory Information Form", 'State Anxiety Scale', 'Hemodynamic Variables Monitoring Form' and 'Surgical Fear Scale' will be filled out for all patients who will undergo TURP.
Patients in the control group will receive routine care.
In the postoperative period, "Hemodynamic Variables Monitoring Form", "Visual Analog Scale" and "Education Satisfaction Scale" will be completed for all patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score
Time Frame: 10 months
|
Visual Analog Scale: It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no pain at all)-10 (very severe pain) to evaluate the level of pain (Wewers and Lowe, 1990).
|
10 months
|
|
Anxiety
Time Frame: 10 months
|
The State Anxiety Scale : In this study, the DAQ, which is structured to measure momentary feelings, was used.
Its Turkish validity and reliability was conducted by Öner and Le Compte in 1983.
The DAQ consists of 20 questions on a four-point Likert scale.
The statements in the DAQ are evaluated as not at all (1), a little (2), a lot (3) and completely (4).
In this section, the statements are divided into direct and reversed statements.
Inverted statements: 1st, 2nd, 5th, 5th, 8th, 8th, 10th, 11th, 15th, 16th, 19th, 20th items.
The total score of the reversed statements is subtracted from the total score of the direct statements and the number 50, which is the invariant value of the DAQ, is added to the value obtained and the DAQ score is calculated.
The scale score ranges between 20-80 and an increase in the score indicates an increase in the level of anxiety.
|
10 months
|
|
Hemodynamic Variables
Time Frame: 10 months
|
Hemodynamic Variables Monitoring Form, hemodynamic variables findings of the mobile treatment and control group before and after TURP will be recorded.
|
10 months
|
|
Surgical Fear
Time Frame: 10 months
|
Surgical Fear Scale: The Turkish validity and reliability study of the scale was conducted by Bağdigen and Karaman Özlü in 2018.
The questionnaire, which consists of eight items, has an 11-point Likert structure ranging from 0 (I am not afraid at all) to 10 (I am very afraid).
The questionnaire has two subscales indicating the fear of short-term and long-term consequences of surgery.
The subscale score is obtained by summing the scores of the four items in the subscales of the questionnaire.
The total score of the questionnaire will be obtained by summing the scores of the two subscales, with a minimum score of 0 and a maximum score of 80.
The Cronbach alpha coefficient of the scale was found to be 0.89, 0.86 for the short-term outcomes sub-dimension and 0.87 for the long-term outcomes (Bağdiven & Karaman Özlü, 2016).
|
10 months
|
|
Urinalysis results
Time Frame: 10 months
|
Hemodynamic Variables Monitoring Form, complete urinalysis (density, bacteriuria, etc.) findings of the mobile treatment and control group before and after TURP will be recorded.
|
10 months
|
|
Education Satisfaction
Time Frame: 10 months
|
Education Satisfaction Scale:It is a scale that provides a subjective assessment of pain on a horizontal or vertical line from 0 (no good at all)-10 (very severe good) to evaluate the level of patient education satisfaction
|
10 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Murat Bozlu, Mersin University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Belarmino A, Walsh R, Alshak M, Patel N, Wu R, Hu JC. Feasibility of a Mobile Health Application To Monitor Recovery and Patient-reported Outcomes after Robot-assisted Radical Prostatectomy. Eur Urol Oncol. 2019 Jul;2(4):425-428. doi: 10.1016/j.euo.2018.08.016. Epub 2018 Sep 10.
- Deniz-Garcia A, Fabelo H, Rodriguez-Almeida AJ, Zamora-Zamorano G, Castro-Fernandez M, Alberiche Ruano MDP, Solvoll T, Granja C, Schopf TR, Callico GM, Soguero-Ruiz C, Wagner AM; WARIFA Consortium. Quality, Usability, and Effectiveness of mHealth Apps and the Role of Artificial Intelligence: Current Scenario and Challenges. J Med Internet Res. 2023 May 4;25:e44030. doi: 10.2196/44030.
- Elterman D, Aube-Peterkin M, Evans H, Elmansy H, Meskawi M, Zorn KC, Bhojani N. UPDATE - Canadian Urological Association guideline: Male lower urinary tract symptoms/benign prostatic hyperplasia. Can Urol Assoc J. 2022 Aug;16(8):245-256. doi: 10.5489/cuaj.7906. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2025
Primary Completion (Actual)
April 1, 2026
Study Completion (Actual)
May 30, 2026
Study Registration Dates
First Submitted
November 9, 2024
First Submitted That Met QC Criteria
November 12, 2024
First Posted (Actual)
November 13, 2024
Study Record Updates
Last Update Posted (Actual)
June 10, 2026
Last Update Submitted That Met QC Criteria
June 7, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TU-BOZKUL-010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer (Post Prostatectomy)
-
Cellvax Therapeutics IncRecruitingProstate Cancer | Prostate Cancer (Adenocarcinoma) | Prostate Cancer Patients Undergoing Radical Prostatectomy | High-risk Prostate Cancer | Prostate CA | Prostate Cancers | Prostate Cancer (Post Prostatectomy)United States
-
East and North Hertfordshire NHS TrustNot yet recruitingProstate Neoplasm | Prostatectomy | Prostate Cancer (Adenocarcinoma) | Prostate Cancers | Prostate Cancer (Post Prostatectomy) | Prostate Cancer SurgeryUnited Kingdom
-
Haitao Niu, MDNot yet recruitingProstate Cancer Patients Undergoing Radical ProstatectomyChina
-
Lithuanian University of Health SciencesRecruitingProstate Cancer (Adenocarcinoma) | Radical Prostatectomy | Prostate Cancer (Diagnosis) | Prostate Specific Antigen | Prostate Cancer (Post Prostatectomy)Lithuania
-
First Affiliated Hospital of Fujian Medical UniversityActive, not recruitingProstate Cancer (Post Prostatectomy) | Urinary Continence | Retzius-sparing Robot-assisted Radical ProstatectomyChina
-
Hacettepe UniversityNot yet recruitingErectile Dysfunction Following Radical Prostatectomy | Post Prostatectomy Incontinence
-
Albert Einstein Healthcare NetworkTerminatedPost ProstatectomyUnited States
-
University of Vermont Medical CenterCompletedProstate Cancer | Post-ProstatectomyUnited States
-
University of MichiganTerminatedProstate Cancer | Post Prostatectomy IncontinenceUnited States
-
Mansoura UniversityCompleted
Clinical Trials on Mobile application
-
Marta MarciniakRecruiting
-
Mississippi State UniversityCompleted
-
Mississippi State UniversityAssociation for contextual behavioral scienceCompletedHealth-Related BehaviorUnited States
-
George Washington UniversityMedia RezCompleted
-
University of ReginaCompletedStress | Dementia | Caregiver BurdenCanada
-
University Hospitals Cleveland Medical CenterCompleted
-
Seda ÇETİN AVCIActive, not recruiting
-
University of CadizCompleted
-
Boston Medical CenterBoston Medical Center Food KitchenWithdrawnDiabetes Mellitus, Type 2 | Pre DiabetesUnited States
-
Instituto de investigación e innovación biomédica...Completed