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临床试验/NCT06687538
NCT06687538
招募中
不适用

The Effect of Education to be Provided to Patients to Undergo Prostate Surgery With Mobile Application on Patient Outcomes

Tarsus University1 个研究点 分布在 1 个国家目标入组 68 人2025年6月3日

概览

阶段
不适用
干预措施
Mobile application
疾病 / 适应症
Prostate Cancer (Post Prostatectomy)
发起方
Tarsus University
入组人数
68
试验地点
1
主要终点
Pain score
状态
招募中
最后更新
2个月前

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2025年6月3日
结束日期
2026年6月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
Male

研究者

发起方
Tarsus University
责任方
Principal Investigator
主要研究者

Gamze BOZKUL

Principal Investigator

Tarsus University

入排标准

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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 "Discharge Training Satisfaction Scale" will be completed for all patients.

干预措施: Mobile application

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 "Discharge Training Satisfaction Scale" will be completed for all patients.

结局指标

主要结局

Pain score

时间窗: 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).

Anxiety

时间窗: 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.

Hemodynamic Variables

时间窗: 10 months

Hemodynamic Variables Monitoring Form, hemodynamic variables findings of the mobile treatment and control group before and after TURP will be recorded.

Surgical Fear

时间窗: 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).

Urinalysis results

时间窗: 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.

Education Satisfaction

时间窗: 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

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