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IRCT20180523039802N3 IRCT 2020-12-13 Shiraz University of Medical Sciences The effect of implementing family-centered empowerment model on adherence to treatment and perceived social support Comparing the effect of two educational methods; Family-centered and traditional empowerment model on adherence to treatment and perceived social support in patients undergoing Bariatric surgery 2020-12-21 anticipated 80 Complete https://irct.ir/trial/42786 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization: Based on the formula of sample size comparison of two means with an error of 5%, with a power of 90% and using the results of a similar study, the sample size in each group was calculated at least 18 people. Which was taken to increase the accuracy of 20 patients in each group. Accordingly, 80 patients who meet the inclusion criteria are randomly divided into two groups of 20 with block randomization (with the size of each block equal to 4). The randomization list is generated and used using random allocation software, Blinding description: The objectives of the research will be explained to the participants. Neither the participants in the experimental group know that there is a control group nor the participants in the control group know that there is an experimental group. Also, the groups are not related to each other. The health care staff of the obesity clinic who are responsible for caring for patients, data collectors, and those evaluating the outcome are also blind and will not be informed of the objectives of the study. N/A Obesity. Intervention 1: Intervention group: Session 1: Perceived threat step. In this session, issues about surgery and its process, complications, risk factors and effects of defects and failures in the treatment plan, methods of prevention and control of complications, self-care behaviors (adherence to diet, medication, exercise regime) and its importance is explained in simple language to patients and their caregivers. Patients' questions will then be discussed and answered. Session 2: Problem-solving step.This meeting will be held aimed at problem-solving. The problem-solving steps include diagnosing the problem, explaining the goals, providing solutions, and selecting the best solution. Discussion on how to choose and implement the best solution to achieve the desired goals according to the ability of the patient and the family, will be the focus of this meeting. At this stage, the skills needed to achieve the goal will be taught (physical exercise, fixing the meal time to prevent reflux and dumping syndrome). Booklets and pamphlets will also be provided to the patient and family. A patient who has undergone surgery and achieved the best postoperative results will also be invited to help provide solutions. Session 3: Educational Participation step. In this session, the patient himself/herself assists the researcher in educating other patients and families. This participation will be done to increase the patient's self-confidence and gain family support. During the research, the researcher will be in contact with patients through social networks and telephone to resolve ambiguities and possible questions. Each session will last for one hour and the last session will be held at least 15 days before surgery. Intervention 2: Control group: The 40-person group will go through the routine procedures of the hospital and will receive routine training. 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 Zahra Sobhani
No. 5, Moalem Street
Shiraz Iran (Islamic Republic of) 7186837152 +98 71 3631 9937 zahrasobhani120@yahoo.com Shiraz University of Medical Sciences scientific Zahra Sobhani
No. 5, Moalem Street
Shiraz Iran (Islamic Republic of) 7186837152 +98 71 3631 9937 zahrasobhani120@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Complete consent to study candidate for Bariatric surgery family member (primary caregiver) with minimum diploma literacy no limit no limit Both Having treatable endocrine disorders Alcohol or drug addiction With severe and well-known mental illness E66 Overweight and obesity Lifestyle Lifestyle Intervention group: Session 1: Perceived threat step. In this session, issues about surgery and its process, complications, risk factors and effects of defects and failures in the treatment plan, methods of prevention and control of complications, self-care behaviors (adherence to diet, medication, exercise regime) and its importance is explained in simple language to patients and their caregivers. Patients' questions will then be discussed and answered. Session 2: Problem-solving step.This meeting will be held aimed at problem-solving. The problem-solving steps include diagnosing the problem, explaining the goals, providing solutions, and selecting the best solution. Discussion on how to choose and implement the best solution to achieve the desired goals according to the ability of the patient and the family, will be the focus of this meeting. At this stage, the skills needed to achieve the goal will be taught (physical exercise, fixing the meal time to prevent reflux and dumping syndrome). Booklets and pamphlets will also be provided to the patient and family. A patient who has undergone surgery and achieved the best postoperative results will also be invited to help provide solutions. Session 3: Educational Participation step. In this session, the patient himself/herself assists the researcher in educating other patients and families. This participation will be done to increase the patient's self-confidence and gain family support. During the research, the researcher will be in contact with patients through social networks and telephone to resolve ambiguities and possible questions. Each session will last for one hour and the last session will be held at least 15 days before surgery. Control group: The 40-person group will go through the routine procedures of the hospital and will receive routine training. Adherence. Timepoint: At baseline and 3 months and 6 months after surgery. Method of measurement: Treatment Compliance Questionnaire. Perceived social support. Timepoint: At baseline and 3 months and 6 months after surgery. Method of measurement: Perceived Social Support Questionnaire. Shiraz University of Medical Sciences Approved 2019-06-09 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran ُShiraz Fars Iran (Islamic Republic of)