Clinical trial NCT06687538: Effect of Education to be Provided to Patients to Undergo TURP With Mobile Application on Patient Outcomes
Official title: The Effect of Education to be Provided to Patients to Undergo Prostate Surgery With Mobile Application on Patient Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer (Post Prostatectomy)
Keywords: Mobile application
Patient education
Patient outcomes
Nursing
Transurethral prostate resection
Lead sponsor: Tarsus University
Sponsor class: OTHER
Collaborators: name: Mersin University
name: Necmettin Erbakan University
First posted: 2024-11-13
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was planned as a prospective, two-arm (1:1), randomized controlled trial.
Primary purpose: OTHER

Brief summary: 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 Discharge 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 "Discharge 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.

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 Discharge 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 "Discharge 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain score
timeFrame: 10 months
measure: Anxiety
timeFrame: 10 months
measure: Hemodynamic Variables
timeFrame: 10 months
measure: Surgical Fear
timeFrame: 10 months
measure: Satisfaction
timeFrame: 10 months
measure: Urinalysis results
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Tarsus University
Study officials:
affiliation: Mersin University
name: Murat Bozlu
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.