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IRCT20180826040874N1 IRCT 2020-03-13 Hamedan University of Medical Sciences The effectiveness of the support group based on Roy’s Model on the adaptation of patients with implantable cardioverter-defibrillators The effectiveness of applying the support group based on Roy’s Model on the adaptation of patients with implantable cardioverter-defibrillators 2020-02-19 anticipated 60 Complete https://irct.ir/trial/45718 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Individuals referred to therapeutic center and with inclusion criteria to the study will selected by convenience sampling method and were randomly divided into intervention and control groups. In this study, individuals were divided into two groups using randomization blocks of 4 method. In this method, A represents the individual receiving the intervention and B represents the individual in the control group. Then codes will indicate as Code 1: AABB, code 2: ABAB, code 3: ABBA, code 4: BAAB, code 5: BBAA and code 6: BABA. After that, the starting point is randomly selected using the random number table. Given the sequence of table numbers, each number that is assigned will be determined a code. For example, if the first three numbers of the random number table are 2, 1 and 6, the order of assigning the first 12 patients in groups of the study will be ABABAABBBABA, respectively. N/A Cardiovascular disease. Intervention 1: Intervention group: patients participate in support group. Selecting the educational topics and content of each support group as well as the patients' health status are identified based on the assessment and recognition form of Roy nursing model. Support group members will include patients with better health status, patients with poor health status, and a family member who is responsible for caring them, as well as a psychologist and researcher. the duration of each session will vary depending on the patients' educational needs. For all patients, two support groups is held at least in one month. The content of these groups included discussions about their past, present and future of illness, actions required after receiving shock, questions and answers to device and illness, suggestions for daily living activities, lifestyle changes and doing sports activities, providing information about phantom shock, driving, marrying, and supporting family members. One and a half months after participating in the support group, patients are reassessed by the assessment and recognition form of Roy nursing model. Intervention 2: Control group: In the control group patients will receive only routine care that includes an educational pamphlet provided by the health center. 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 The decision will be with research team
public Mohammadreza Razavi
Shahid Fahmideh Ave., Pajohesh Squ., Hamadan City
Hamadan Iran (Islamic Republic of) 6517765178 +98 81 3827 1145 mrerazavi@yahoo.com Hamedan University of Medical Sciences scientific Mohammadreza Razavi
Shahid Fahmideh Ave., Pajohesh Squ., Hamadan City
Hamadan Iran (Islamic Republic of) 6517765178 +98 81 3827 1145 mrerazavi@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) maximum age of 60 years Hearing and speaking ability lack of diagnosed mental disease Patients with cardiac defibrillator implantation for at least six months no limit 60 years Both Failure to complete the nursing assessment and recognition Z95.810 Presence of automatic (implantable) cardiac defibrillator Behavior N/A Intervention group: patients participate in support group. Selecting the educational topics and content of each support group as well as the patients' health status are identified based on the assessment and recognition form of Roy nursing model. Support group members will include patients with better health status, patients with poor health status, and a family member who is responsible for caring them, as well as a psychologist and researcher. the duration of each session will vary depending on the patients' educational needs. For all patients, two support groups is held at least in one month. The content of these groups included discussions about their past, present and future of illness, actions required after receiving shock, questions and answers to device and illness, suggestions for daily living activities, lifestyle changes and doing sports activities, providing information about phantom shock, driving, marrying, and supporting family members. One and a half months after participating in the support group, patients are reassessed by the assessment and recognition form of Roy nursing model. Control group: In the control group patients will receive only routine care that includes an educational pamphlet provided by the health center. Adaptation of patients. Timepoint: before and 1.5 months after intervention. Method of measurement: Adaptation is measured using assessment and recognition form of Roy nursing model. In this study, secondary outcome is level of social adaptation. Timepoint: Level of social adaptation is measured at before and 1.5 months after intervention. Method of measurement: Level of social adaptation is measured using Bell adaptation questionnaire. Hamedan University of Medical Sciences Approved 2020-02-09 Ethics committee of Hamadan University of Medical Sciences Shahid Fahmideh Ave, Pajohesh Squ., Hamadan city Hamadan Hamadan Iran (Islamic Republic of)