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IRCT20100725004443N24 IRCT 2018-12-29 Shaheed Rajaie's Cardiovascular Medical and Research Center Effectiveness of continues care program on self efficacy and outcomes in patients with cardiac shocker Effectiveness of continues care program on self efficacy and outcomes in patients with Implantable Cardioverter Defibrillator 2018-12-31 anticipated 154 Complete https://irct.ir/trial/4761 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Assignment of patients in two groups of test and control was done by Block Balanced Randomization (BBR) method. The Randomization Sequence was generated with using the free web site at http://www.randomization.com, Blinding description: When discharging the patient, the researcher trains on the research and its method. However, he does not make the patient aware of his group and the researcher is not the member of the staff and the hospital staff does not participate in the intervention. N/A The patient with an Implantable Cardioverter Defibrillator. Intervention 1: Control group:This patients do not receive any intervention from the researcher and are discharged after receiving regular care at the facility. Intervention 2: Intervention group: The intervention includes two training sessions for 1.5 hours by the researcher and one month later, they go to the health-care center. In these sessions, the researcher trains the patients about the ability to take care of oneself after received shock, the way to register the shocks, the performance of the Device, their feeling when evacuating the energy and the required changes in lifestyle, the warning and follow-up and their relationship with the family members is explained. The researcher tells about the ways of reducing stress such as praying, relaxation, listening to music and distraction of mind and describes the solution based on the patient's will. After the second session,a training book is given to the patients including two parts. The first part explains the performance and equipment and the second part is about the experience of patients with Implantable Cardioverter Defibrillator. Finally, the patient's phone number is taken and the patient is followed from 8 am to 8 pm for 10 to 20 minutes based on the patient's need, verbal encouragement, responsiveness of the patient's questions, their current concerns, behavioral techniques to be consistent with the living conditions with heart shocker and relaxation in the book. In addition to phone follow-up, the participants in the intervention can access the researcher from morning to night and ask their questions. 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 Zakerimoghadam Masoumeh
Nursing and Midwifery College of Tehran University, Easte Nosrat St., Tohid Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 zakerimo@sina.tums.ac.ir Tehran University of Medical Sciences scientific Haghjoo Majid
Shaheed Rajaie's Cardiovascular Medical and Rresearch Center, Niayesh Blvd., Vali-Asr Ave.,
Tehran Iran (Islamic Republic of) 1996911151 +98 21 2392 2358 majid.haghjoo@gmail.com Shaheed Rajaie's Cardiovascular Medical and Rresearch Center Iran (Islamic Republic of) Being 20 to 80 years old Being ability to read, write, and speak in Persian Accessing phone call Implanting Cardioverter Defibrillator for the first time 20 years 80 years Both Suffering from Cognitive Disorders Suffering from Commorbidity results in hospitalization Participation in other intervention program Other Other Control group:This patients do not receive any intervention from the researcher and are discharged after receiving regular care at the facility. Intervention group: The intervention includes two training sessions for 1.5 hours by the researcher and one month later, they go to the health-care center. In these sessions, the researcher trains the patients about the ability to take care of oneself after received shock, the way to register the shocks, the performance of the Device, their feeling when evacuating the energy and the required changes in lifestyle, the warning and follow-up and their relationship with the family members is explained. The researcher tells about the ways of reducing stress such as praying, relaxation, listening to music and distraction of mind and describes the solution based on the patient's will. After the second session,a training book is given to the patients including two parts. The first part explains the performance and equipment and the second part is about the experience of patients with Implantable Cardioverter Defibrillator. Finally, the patient's phone number is taken and the patient is followed from 8 am to 8 pm for 10 to 20 minutes based on the patient's need, verbal encouragement, responsiveness of the patient's questions, their current concerns, behavioral techniques to be consistent with the living conditions with heart shocker and relaxation in the book. In addition to phone follow-up, the participants in the intervention can access the researcher from morning to night and ask their questions. Self-efficacy. Timepoint: Before the intervention, immediately after ending the intervention. Method of measurement: Self-efficacy questionnaire. Anxiety. Timepoint: Before the intervention, immediately after ending the intervention. Method of measurement: Speil-berger State-Trait Anxiety Inventory. Number of received shocks. Timepoint: Immediately after ending the intervention. Method of measurement: patient report. Referrals outside of the plan to Medical centers. Timepoint: Immediately after ending the intervention. Method of measurement: patient report. Shaheed Rajaie's Cardiovascular Medical and Research Center Approved 2017-01-23 Ethic commitee of Shaheed Rajaie's Cardiovascular Medical and Rresearch Center Shaheed Rajaie's Cardiovascular Medical and Rresearch Center, Niayesh Blvd., Vali-Asr Ave. Tehran Tehran Iran (Islamic Republic of)