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IRCT20100725004443N28 IRCT 2020-01-11 Tehran University of Medical Sciences The effect of self-care education with smartphone application on complications of stem cell transplantation The effect of self-care education with smartphone application on complications of stemcell transplantation in leukemic patients 2019-07-23 anticipated 104 Complete https://irct.ir/trial/40602 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The samples will be selected by continuous sampling and the patients will be placed in two groups of control and intervention by Block Balanced Randomization (BBR). By using the free web site http://www.randomization.com/, the assignment sequence will take place. N/A complications of stemcell transplantation in leukemic patients. Intervention 1: Control group: For patients in the control group, routine care and routine training includes a pre-transplant group training session that is conducted through the lecture center at the transplantation center. Intervention 2: Intervention group: In Intervention group, the researcher train the self-care education program with smart phone application in addition to the routine training of the transplantation center. this application was made by the researcher and confirmed by four experts. we give the smartphone application to the patient or his caregiver (in patients who need care) and train them how to use the application and practice with them and also their possible questions are answered. if there is a problem or the question to answer them the researcher's mobile phone number is given to them. also the patient's phone number will be taken by the researcher and will be contacted by the investigator weekly at least 10 minutes in the morning or evening, in order to encourage the use of the educational application and respond to the patient's likely questions.This smartphone application includes: leukemia, treatment methods, familiarity with bone marrow transplantation and its stages of action, possible complications and self-care methods for these patients, training in appropriate post-transplant nutrition, training on how to control infection , Cleaning, bathing, hand washing, oral hygiene, the way and rate of meeting and communication with others and observing its principles, possible complications of the disease and methods for preventing complications and early diagnosis, relief of symptoms, control and prevention methods Nausea and vomiting, oral ulcers and mucositis, and anxiety control methods.this smartphone application are approved by four members of the faculty and transplantation department. During the intervention, which starts from the beginning of pre-transplant chemotherapy as a linkage regimen and continue for up to three months after the transplantation, the questionnaire for transplantation complication will be completed Selectively in both control and intervention groups after two weeks, one and three months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Jalal Rezaei
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat St. Tohid Sq Tehran I.IRAN
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4000 jalalrezaei1989@gmail.com Tehran University of Medical Sciences scientific Dr Masoumeh Zakeri Moghaddam
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq Tehran I.IRAN
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6105 4000 mzakerimo@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Have at least reading and writing skills Age between 15 and 60 years Having an Android mobile phone by a patient or his family Lack of psychological disorders detected Patients with leukemia candidates for stem cell transplantation 15 years 60 years Both The client is not simultaneously involved in another research as a research sample The client does not want to use the application If the client is from the medical staff The client or his/her family has a history of bone marrow transplantation C95.9 Leukemia, unspecified Other Other Control group: For patients in the control group, routine care and routine training includes a pre-transplant group training session that is conducted through the lecture center at the transplantation center. Intervention group: In Intervention group, the researcher train the self-care education program with smart phone application in addition to the routine training of the transplantation center. this application was made by the researcher and confirmed by four experts. we give the smartphone application to the patient or his caregiver (in patients who need care) and train them how to use the application and practice with them and also their possible questions are answered. if there is a problem or the question to answer them the researcher's mobile phone number is given to them. also the patient's phone number will be taken by the researcher and will be contacted by the investigator weekly at least 10 minutes in the morning or evening, in order to encourage the use of the educational application and respond to the patient's likely questions.This smartphone application includes: leukemia, treatment methods, familiarity with bone marrow transplantation and its stages of action, possible complications and self-care methods for these patients, training in appropriate post-transplant nutrition, training on how to control infection , Cleaning, bathing, hand washing, oral hygiene, the way and rate of meeting and communication with others and observing its principles, possible complications of the disease and methods for preventing complications and early diagnosis, relief of symptoms, control and prevention methods Nausea and vomiting, oral ulcers and mucositis, and anxiety control methods.this smartphone application are approved by four members of the faculty and transplantation department. During the intervention, which starts from the beginning of pre-transplant chemotherapy as a linkage regimen and continue for up to three months after the transplantation, the questionnaire for transplantation complication will be completed Selectively in both control and intervention groups after two weeks, one and three months. Anxiety and depression(A score above 11 based on the Hospital Anxiety and Depression Scale). Timepoint: Two weeks, one and three months after the intervention. Method of measurement: Hospital Anxiety and Depression Scale. Nausea(Mild or Moderate or Severe by Scale). Timepoint: Two weeks, one and three months after the intervention. Method of measurement: Visual analogue scale (VAS). Vomiting(Mild or Moderate or Severe by Scale). Timepoint: Two weeks, one and three months after the intervention. Method of measurement: khavar oncology scale. Mucositis(Grade 0 to Grade 4 by scale). Timepoint: Two weeks, one and three months after the intervention. Method of measurement: Form of diagnosis and severity of mucositis. Infection(yes or no based on scale). Timepoint: One and three months after the intervention. Method of measurement: Clinical and laboratory signs and symptoms of infection in patients undergoing stem cell transplantation. Readmission. Timepoint: One and three months after the intervention. Method of measurement: Readmission Rate Form. Tehran University of Medical Sciences Approved 2019-06-19 Ethics committee of Tehran University of Medical Sciences Office building of Tehran University of medical Sciences, Keshavarz St, Tehran. Tehran Tehran Iran (Islamic Republic of)