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IRCT20201231049897N1 IRCT 2021-01-15 Mashhad University of Medical Sciences The effect of self- care education based on tele-nursing approach on quality of life and satisfaction of patients with upper gastrointestinal bleeding The effect of self- care education based on tele-nursing approach on quality of life and satisfaction of patients with upper gastrointestinal bleeding 2021-01-20 anticipated 96 Complete https://irct.ir/trial/53429 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Random allocation will be made in blocks in order to keep the sizes of treatment groups similar. According to the sample size population, two groups of 46 people, intervention and control, considering the possibility of reduction during the study, 20 groups with 5 participants in each block will be allocated. Randomization is done in each group with SPSS software. So, the investigator does not interfere in how sequencing participant assigned by block , Blinding description: Patients are kept blind in this study, and each participant will only receive full explanation of the educational conditions he or she is going to experience in this study, and is unaware of which group he or she belongs to and each patient will receive his or her trainings individually in a private room. Healthcare personnel will also be blind about how patients are assigned to the groups, so they will educate the patients all routine pre-discharge trainings in his/her specific ward equally. The person who performs the final evaluation and also the statistical expert who performs the statistical analysis is blind in this study and finally the researcher will not interfere her personal opinion in the allocation and sequencing of control and intervention groups since this would be done SPSS software . N/A Upper gastrointestinal bleeding and tele-nursing. Intervention 1: Intervention group: In the first session: After obtaining informed consent from patients and having the code of ethics from Ethics committee of Medical science university of Mashhad, the researcher will ask patients who are hospitalized in the surgery or emergency department of educational hospitals to fulfill 3 surveys:( the demographic and disease data, tele-nursing satisfaction questionnaire and gastrointestinal quality of life index). After basic introduction researcher emphasizes on making a proper relationship with the patient by active listening, using appropriate sentences to prove professional competence and having up-to-date information ,also gaining trust and encouragement to cooperate with the patient in the care and education process. Then,The intervention will be continued virtually. Session 2: In a face-to-face session the investigator will introduce the user guide of a self-care application, specifies for gastrointestinal bleeding patients, answers their questions about how to install this app on their smartphones also provides a user manual book for them. Interaction channel via an application on smartphone : These sessions will be held virtually after the patient is discharged. The goal of daily use of this application, as an outside resource, is to increase self-care awareness and knowledge of these patients in three aspects: diet, activity and rest. In addition patients would be familiar with their disease classification, how to face with complication of their medications and recurrent signs and symptoms. They could also report their experimental tests like: CBC,weight,etc. Alarms could be set to remind their visit or medication time. ّThe call nurse menu will engage them to report their documents to the investigator. Second way of virtual interaction is planned via telephone call: Each patient would receive 2 calls weekly between 8Am-8Pm during one month follow-up, which will be performed by validated questionnaire and focuses on four main factors in satisfaction of telenursing questionnaire, including: Health information, effective support, decision making, professional competence and self-care education. The duration of each call differs, depends on patients needs. The third way of telenursing approach in this study is establishing group discussions in whatsapp based on source of their bleeding by the aim of sharing similar concerns in similar patients to engage more interaction. Like: Their daily issues about diet,activity and psychological problems and same challenges in medication complications and finally, modeling correct behaviour through patient's need to improve their self-care skills.The duration of each session would be 30-45 minutes twice a week but could be stretched based on group necessities. Intervention 2: Control group: The admitted upper gastrointestinal bleeding patients in emergency and gastrointestinal wards of educational hospitals in Mashhad city would fulfill three questionnaires at the beginning of the study and 2 and 4 weeks after that, which contains: informed consent, demographic data, gastrointestinal quality of life index and tele-nursing intervention and satisfaction questionnaire. This group will benefit from all routine trainings before discharge from hospital and they will receive all educational materials same as intervention group in a form of educational pamphlets. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Reihaneh Lajevardi
School of Nursing and Midwifery, Ebne sina Ave, ِDoctora intersection, Daneshgah St.
Mashhad Iran (Islamic Republic of) 91375345 +98 51 3859 1511 rlajevardir@gmail.com Mashhad University of Medical Sciences scientific Reihaneh Lajevardi
Mashhad Faculty of Nursing and Midwifery, Ebne Sina St, Doctora intersection, Daneshgah St, Mashhad
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 lajvardir921@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Signing informed consent to participate in the study. suffering from upper gastrointestinal bleeding. The age of patients should be between 20 to 65 years. Do not participate in other self-care education programs at the same time. Having access to a smartphone. Be literate in using a smartphone. 20 years 65 years Both If the patient has psychological problems. If the patient has gastrointestinal bleeding with esophageal varices and liver cirrhosis source. If the patient has a diagnosis of inflammatory bowel disease. If the patient becomes unstable during the study or needs surgery. If the patient dies during the study. If the patient does not want to continue to cooperate during the study. K29.0 Acute gastritis or erosion with bleeding Lifestyle Lifestyle Intervention group: In the first session: After obtaining informed consent from patients and having the code of ethics from Ethics committee of Medical science university of Mashhad, the researcher will ask patients who are hospitalized in the surgery or emergency department of educational hospitals to fulfill 3 surveys:( the demographic and disease data, tele-nursing satisfaction questionnaire and gastrointestinal quality of life index). After basic introduction researcher emphasizes on making a proper relationship with the patient by active listening, using appropriate sentences to prove professional competence and having up-to-date information ,also gaining trust and encouragement to cooperate with the patient in the care and education process. Then,The intervention will be continued virtually. Session 2: In a face-to-face session the investigator will introduce the user guide of a self-care application, specifies for gastrointestinal bleeding patients, answers their questions about how to install this app on their smartphones also provides a user manual book for them. Interaction channel via an application on smartphone : These sessions will be held virtually after the patient is discharged. The goal of daily use of this application, as an outside resource, is to increase self-care awareness and knowledge of these patients in three aspects: diet, activity and rest. In addition patients would be familiar with their disease classification, how to face with complication of their medications and recurrent signs and symptoms. They could also report their experimental tests like: CBC,weight,etc. Alarms could be set to remind their visit or medication time. ّThe call nurse menu will engage them to report their documents to the investigator. Second way of virtual interaction is planned via telephone call: Each patient would receive 2 calls weekly between 8Am-8Pm during one month follow-up, which will be performed by validated questionnaire and focuses on four main factors in satisfaction of telenursing questionnaire, including: Health information, effective support, decision making, professional competence and self-care education. The duration of each call differs, depends on patients needs. The third way of telenursing approach in this study is establishing group discussions in whatsapp based on source of their bleeding by the aim of sharing similar concerns in similar patients to engage more interaction. Like: Their daily issues about diet,activity and psychological problems and same challenges in medication complications and finally, modeling correct behaviour through patient's need to improve their self-care skills.The duration of each session would be 30-45 minutes twice a week but could be stretched based on group necessities. Control group: The admitted upper gastrointestinal bleeding patients in emergency and gastrointestinal wards of educational hospitals in Mashhad city would fulfill three questionnaires at the beginning of the study and 2 and 4 weeks after that, which contains: informed consent, demographic data, gastrointestinal quality of life index and tele-nursing intervention and satisfaction questionnaire. This group will benefit from all routine trainings before discharge from hospital and they will receive all educational materials same as intervention group in a form of educational pamphlets. Satisfaction score which is accessed by tele-nursing intervention and satisfaction questionnaire . Timepoint: Before intervention and 2, 4 weeks after intervention. Method of measurement: Tele-nursing intervention and satisfaction tool to measure satisfaction and The gastrointestinal quality of life index to measure quality of life. Access more than 45 in gastrointestinal quality of life index. Timepoint: Before intervention and 2, 4 , 6 weeks after intervention. Method of measurement: Gastrointestinal quality of life index to measure quality of life in gastrointestinal patients. Vice Chancellor for Research and Technology of Mashhad University of Medical Sciences and Health Services Approved 2021-01-02 Ethics committee of medical science university of Mashhad 4th floor,No.22, 13th Eghbal Lahoori alley, Eghbal Lahoori st, Vakil Abad Blv Mashhad Razavi Khorasan Iran (Islamic Republic of)