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IRCT20200313046758N1 IRCT 2020-06-28 Shiraz University of Medical Sciences Diabetic rehabilitation effect on type 2 diabetic patients and their family caregivers Investigating the effect of diabetic rehabilitation on happiness and resilience of type 2 diabetic patients and their family caregivers, referring to diabetes clinics affiliated to Shiraz Medical Science University, in 1998-99 2020-04-19 anticipated 156 Complete https://irct.ir/trial/46513 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The present study will be performed on type 2 diabetic patients and their family caregivers, Taking into account the drop of 10%, 39 patients and 39 family caregivers will be included in a total of 78 people in each of the intervention and control groups, Randomization description: Samples are first selected using the available sampling method using a random number table and according to the input criteria, then complete the questionnaires and random allocation using Random allocation software to generate a block randomization list, With the size of 4 blocks of 17 and 2 blocks of 5, a total of 6 blocks will be in two groups of intervention and control, which will be a total of 78 people, 39 people in the intervention group and 39 people in the control group, It should be noted that since the present study will be performed on the patient and his family caregiver, the patient's family caregiver will also be subject to intervention, taking into account the intervention group of 78 people, 39 patients plus 39 family caregivers, and the control group 78 A total of 156 people, 39 patients plus 39 family caregivers, will be included, Blinding description: Given that the questionnaires are distributed at all stages by the researcher and also the data analyzer will be unaware of the random allocation of groups to the intervention and control group, then the outcome assessor and data analyzer from the intervention and control groups they will not be aware. N/A Condition 1: Type 2 diabetic patients. Condition 2: Family caregivers of type 2 diabetic patients. Intervention 1: Intervention group, during 8 weeks and 8 face-to-face sessions will receive the rehabilitation program for diabetes, including introduction of diabetes education, treatment and its complications, foot care and self-control of blood sugar, nutrition and diet, exercise and amount of daily activity Individual, happiness training that includes, motivation and purpose, communicating with others and receiving support from them, being active, achieving, feeling positive and resilience training that includes, gaining self-awareness skills, positive thinking and optimism, problem-solving skills and anger management, crisis management and coping strategies, and the eighth session of diabetes management itself, which includes a summary of what has been said in previous sessions; And 8 times by phone, every 8 weeks after each training session Present and before the next meeting, based on the rehabilitation program and with the objectives of teaching, and if necessary, re-teaching the topics discussed in the face-to-face meetings, removing ambiguities and answering sample questions and remembering the time and place of the meeting The future will be and at the end of each session, educational pamphlets will be distributed. Intervention 2: Control group, will receive no intervention and will only receive the clinical care routine, training on diet and medication. 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 is available
public Dr. Mahnaz Rakhshan
Fatemeh Nursing and Midwifery Faculty, Namazi Hospital, Namazi Square
Shiraz Iran (Islamic Republic of) ۱۳۱۱۹ - ۷۱۹۳۶ 0098 7136474254-8 rakhshanm@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Mahnaz Rakhshan
Fatemeh Nursing and Midwifery Faculty, Namazi Hospital, Namazi Square
Shiraz Iran (Islamic Republic of) ۱۳۱۱۹ - ۷۱۹۳۶ 0098 7136474254-8 rakhshanm@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Diagnosis of diabetes by a specialist literacy Patients and their family caregivers willingness and satisfaction with to participate in the study Physical ability to travel to the clinic no limit no limit Both Failure to attend the training session for two consecutive sessions Mental retardation and mental disorders Unpleasant events for the samples during the study (such as losses and calamities that can aggravate distress or prevent participation in the intervention and continue cooperation in the study) The incidence of sickness in the samples that causes them to be hospitalized and prevents them from participating in the intervention and continuing to work with the researcher E11 E11 Type 2 diabetes mellitus Type 2 diabetes mellitus Rehabilitation Treatment - Drugs Intervention group, during 8 weeks and 8 face-to-face sessions will receive the rehabilitation program for diabetes, including introduction of diabetes education, treatment and its complications, foot care and self-control of blood sugar, nutrition and diet, exercise and amount of daily activity Individual, happiness training that includes, motivation and purpose, communicating with others and receiving support from them, being active, achieving, feeling positive and resilience training that includes, gaining self-awareness skills, positive thinking and optimism, problem-solving skills and anger management, crisis management and coping strategies, and the eighth session of diabetes management itself, which includes a summary of what has been said in previous sessions; And 8 times by phone, every 8 weeks after each training session Present and before the next meeting, based on the rehabilitation program and with the objectives of teaching, and if necessary, re-teaching the topics discussed in the face-to-face meetings, removing ambiguities and answering sample questions and remembering the time and place of the meeting The future will be and at the end of each session, educational pamphlets will be distributed Control group, will receive no intervention and will only receive the clinical care routine, training on diet and medication Happiness score. Timepoint: First time, before beginning the intervention, second time, at the end of the 8th session, third time, 5 weeks after the second time. Method of measurement: Oxford Happiness Questionnaire. Resiliency score. Timepoint: First time, before beginning the intervention, second time, at the end of the 8th session, third time, 5 weeks after the second time. Method of measurement: Conner and Davidson Resiliency scale. Shiraz University of Medical Sciences Approved 2020-02-16 Ethics committee of Shiraz University of Medical Sciences Fatemeh Nursing and Midwifery Faculty, Namazi Hospital, Namazi Square Shiraz Fars Iran (Islamic Republic of)