]>
IRCT20150607022592N1 IRCT 2022-09-14 Mashhad University of Medical Sciences The effect of self- care education application on quality of life and satisfaction of patients with Cholecystitis and Cholangitis The effect of self- care education application on quality of life and satisfaction of patients with Cholecystitis and Cholangitis 2022-10-23 anticipated 108 Complete https://irct.ir/trial/65713 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The method of randomization in the present study will be done using 29 permutation blocks of 4 retrieved using Excel software.Sampling is done in such a way that if the patient meets the inclusion criteria, the blocks will be referred, and if the character is A, the patient will be in the intervention group, and if the character is B, the patient will be placed in the control group.The concealment in this study is that the blocks are placed in closed envelopes in order, and in each envelope, there are smaller envelopes, in which the group in question is placed in the block, and the researcher from the envelope The next patient in the next group will not be notified. 3 Condition 1: Chronic cholecystitis. Condition 2: Calculus of gallbladder with other cholecystitis. Intervention 1: Intervention group:The present study is carried out in two main parts: First part: In this stage, the design and validation of the application is done, which we will discuss in detail below. The application design steps are: 1. Studying and reviewing specialized texts to extract the educational content of the application. In the first phase of the design, the researcher begins to search for information databases (and...clinical key-up to date) and authentic books in the field of teaching patients with cephalocystitis and cholangitis, and the latest content available in It extracts topics such as diet, how to exercise and rest, taking medicines, facing the symptoms and complications of the disease, how to go to the doctor and control the tests, etc.Then he searched for educational films and animations related to patients, which will be translated and voiced into Persian if necessary. Also, related educational voices will be recorded based on the prepared content, and the prepared content will be available to the programming team and computer specialists, including various sections and menus for this application. The headings presented in the menu related to the educational content of the application include the following:Familiarity with cystitis and cholangitis, its symptoms, physiology, diagnosis and treatment - how to deal with acute complications including: pain, management of disease symptoms - educational materials about self-care in diet, activity and rest, taking medications, skin care, Care against possible complications. Among the features in addition to the educational aspect that is embedded in the application, there is a menu for recording tests by the patient (to help with subsequent follow-ups), a menu for entering the patient's basic information, an alarm menu for defining the time to remind the patient of visits and medications, and a search menu. To find the desired phrase, he mentioned the menu of common questions for questions and answers between patients and the research team, the menu of communication with the researcher and the menu of the application guide.The second part: conducting a randomized clinical trial. The second part includes conducting a randomized clinical trial research in the statistical population of patients with cholecystitis and cholangitis referred to Imam Reza and Qaem Hospitals in Mashhad in 1401. After obtaining the permission of the ethics committee and the final IRCT code, the researcher will be present in the research environment and the sampling will be done as follows: intervention group in the applied software group after doing Endoscopic Retrograde Cholangiopancreatography ( ERCP) and before the discharge of patients from the hospital in the training phase during nursing discharge. In addition to the usual trainings (educational pamphlets and face-to-face training), the researcher, after introducing the research and obtaining the informed consent of the patient, taught the patient or one of his companions how to install the software on the smartphone and provided a booklet on how to use the software. It provides the software to them.The researcher emphasizes the necessity of using applications by the patient to prevent the recurrence of the disease. Then the patient is asked to enter the WhatsApp group through the link placed in the application. so that they can express their questions and concerns about the disease and the researcher can follow up their self-care performance at home. . Finally, the patients will be followed up by the researcher for one month by calling them once or twice a week. The gastrointestinal quality of life index (GILQI) will be completed before the intervention, two weeks and four weeks after the intervention. However, Mobile application Rating Scale (MARS), Telenursing Interaction and Satisfaction Questionnaire (TISQ) will be completed two weeks and four weeks after the start of the intervention in these patients. Intervention 2: Control group: In the control group, after ERCP and before the patients are discharged from the hospital, during the nursing discharge training phase, the usual trainings of the department, including educational pamphlets and face-to-face training, will be conducted by nurses under the supervision of the researcher. After introducing the research and obtaining informed consent, the researcher asks the patient to complete the demographic and disease information questionnaire and the GIQLI score quality of life questionnaire. Then the patient's contact number is received by the researcher and the researcher calls the patient once or twice a week and answers his questions.It should be mentioned that in this group of patients, the researcher tries to answer only the patients' questions. At the end of two weeks and four weeks, the patients are asked to complete the GIQLI quality of life score and the questionnaire of satisfaction with the nurse's contact and follow-up (TISQ). The researcher will be placed in the software so that the patients can contact the researcher in case of problems. At the end of the research, the application will be available to the patients of the control group. And at the end, the data analysis will be done with the help of descriptive and inferential statistical tests. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Nahid Aghebati
Daneshgah street, Ebne Sina Avenue, Nursing and Midwifery School, Mashhad University of Medical Sciences.
Mashhad Iran (Islamic Republic of) 91375345 +98 51 3859 1511 aghebatin@mums.ac.ir Mashhad University of Medical Sciences scientific Nahid Aghebati
Daneshgah street, Ebne Sina Avenue, Nursing and Midwifery School, Mashhad University of Medical Sciences.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 aghebatin@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Willingness to participate in the study Age 18-60 years Having a diagnosis of obstructive disorders of the bile ducts or uncomplicated cholelithiasis or cholecystitis No diagnosed mental disorder No cognitive impairment Mastering the Persian language Failure to participate in a previous or current self-care program Android smartphone access 18 years 60 years Both K81.1 K80.1 Chronic cholecystitis Calculus of gallbladder with other cholecystitis Lifestyle Lifestyle Intervention group:The present study is carried out in two main parts: First part: In this stage, the design and validation of the application is done, which we will discuss in detail below. The application design steps are: 1. Studying and reviewing specialized texts to extract the educational content of the application. In the first phase of the design, the researcher begins to search for information databases (and...clinical key-up to date) and authentic books in the field of teaching patients with cephalocystitis and cholangitis, and the latest content available in It extracts topics such as diet, how to exercise and rest, taking medicines, facing the symptoms and complications of the disease, how to go to the doctor and control the tests, etc.Then he searched for educational films and animations related to patients, which will be translated and voiced into Persian if necessary. Also, related educational voices will be recorded based on the prepared content, and the prepared content will be available to the programming team and computer specialists, including various sections and menus for this application. The headings presented in the menu related to the educational content of the application include the following:Familiarity with cystitis and cholangitis, its symptoms, physiology, diagnosis and treatment - how to deal with acute complications including: pain, management of disease symptoms - educational materials about self-care in diet, activity and rest, taking medications, skin care, Care against possible complications. Among the features in addition to the educational aspect that is embedded in the application, there is a menu for recording tests by the patient (to help with subsequent follow-ups), a menu for entering the patient's basic information, an alarm menu for defining the time to remind the patient of visits and medications, and a search menu. To find the desired phrase, he mentioned the menu of common questions for questions and answers between patients and the research team, the menu of communication with the researcher and the menu of the application guide.The second part: conducting a randomized clinical trial. The second part includes conducting a randomized clinical trial research in the statistical population of patients with cholecystitis and cholangitis referred to Imam Reza and Qaem Hospitals in Mashhad in 1401. After obtaining the permission of the ethics committee and the final IRCT code, the researcher will be present in the research environment and the sampling will be done as follows: intervention group in the applied software group after doing Endoscopic Retrograde Cholangiopancreatography ( ERCP) and before the discharge of patients from the hospital in the training phase during nursing discharge. In addition to the usual trainings (educational pamphlets and face-to-face training), the researcher, after introducing the research and obtaining the informed consent of the patient, taught the patient or one of his companions how to install the software on the smartphone and provided a booklet on how to use the software. It provides the software to them.The researcher emphasizes the necessity of using applications by the patient to prevent the recurrence of the disease. Then the patient is asked to enter the WhatsApp group through the link placed in the application. so that they can express their questions and concerns about the disease and the researcher can follow up their self-care performance at home. . Finally, the patients will be followed up by the researcher for one month by calling them once or twice a week. The gastrointestinal quality of life index (GILQI) will be completed before the intervention, two weeks and four weeks after the intervention. However, Mobile application Rating Scale (MARS), Telenursing Interaction and Satisfaction Questionnaire (TISQ) will be completed two weeks and four weeks after the start of the intervention in these patients. Control group: In the control group, after ERCP and before the patients are discharged from the hospital, during the nursing discharge training phase, the usual trainings of the department, including educational pamphlets and face-to-face training, will be conducted by nurses under the supervision of the researcher. After introducing the research and obtaining informed consent, the researcher asks the patient to complete the demographic and disease information questionnaire and the GIQLI score quality of life questionnaire. Then the patient's contact number is received by the researcher and the researcher calls the patient once or twice a week and answers his questions.It should be mentioned that in this group of patients, the researcher tries to answer only the patients' questions. At the end of two weeks and four weeks, the patients are asked to complete the GIQLI quality of life score and the questionnaire of satisfaction with the nurse's contact and follow-up (TISQ). The researcher will be placed in the software so that the patients can contact the researcher in case of problems. At the end of the research, the application will be available to the patients of the control group. And at the end, the data analysis will be done with the help of descriptive and inferential statistical tests. Quality of life. Timepoint: The quality of life questionnaire will be completed before the intervention, two weeks and four weeks after the intervention. Method of measurement: Gastrointestinal Quality of Life Index score (GIQLI). Mobile app satisfaction. Timepoint: Two weeks and four weeks after the start of the intervention. Method of measurement: Mobile Application Rating Scale (MARS). Telenursing satisfaction. Timepoint: Two weeks and four weeks after the start of the intervention. Method of measurement: Telenursing Interaction and Satisfaction Questionnaire (TISQ). Vice President of Research and Technology of Mashhad University of Medical Sciences and Health Services Approved 2022-07-05 Ethics committee of Mashhad University of Medical Sciences Daneshgah street , Ebn-Sina Ave Mashhad Nursing and Midwifery School Mashhad Razavi Khorasan Iran (Islamic Republic of)