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IRCT20250329065176N2 IRCT 2025-04-30 Tehran University of Medical Sciences The effect of supportive educative program on quality of life and caregiver burden of patients with hip fracture The effect of supportive educative program on quality of life and caregiver burden of patients with hip fracture 2025-05-22 anticipated 70 Complete https://irct.ir/trial/82789 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, simple randomization was used to allocate participants into intervention and control groups. The unit of randomization was individual; that is, each eligible caregiver was assigned independently. The random sequence was generated using SPSS software (version 26). The principal investigator created a numbered list of eligible participants and applied the "Random Sample of Cases" function to assign individuals randomly to either the intervention or control group in a 1:1 ratio (40 participants per group). To prevent data contamination between groups, recruitment was sequential in time: first, all control group participants were recruited, followed by the intervention group. Allocation concealment was ensured by placing the final allocation list into sealed, opaque, numbered envelopes. These envelopes were handled solely by an independent research assistant who was not involved in data collection or analysis. The statistical analyst was blinded to group assignments (single-blind design). Stratified or block randomization was not applied in this study, as preliminary analysis indicated no significant imbalance in key baseline variables across groups, Blinding description: Clinical caregivers: Doctors, nurses and physiotherapists responsible for the treatment of patients were not involved in the research educational intervention and were (blinded to the grouping of companies). Data analyst (data analyst) The person responsible for the statistical analysis of the data had access only to the numerical coding of the groups (without knowledge of whether they were control or intervention). Therefore, complete blinding was observed in this role. N/A Caregivers of hip fracture patients. Intervention 1: Intervention group: In this study, the intervention involved a supportive educative program for caregivers of patients with hip fracture. No medications, chemical agents, surgeries, or invasive procedures were involved. Therefore, only a detailed description of the educational intervention is provided:Content of the Intervention:The supportive educational program was structured around two main components:Home care training for patients post-hip fracture surgeryProblem-focused coping skills training (effective communication, anger management, deep breathing techniques)Program Components:Session 1: Basic home care principles post-hip fracture surgery (patient transfer, pressure sore prevention, early mobilization assistance, nutritional advice)Session 2: Prevention of secondary complications (infection, thrombosis, fall prevention) and home safety strategiesSession 3: Effective communication skills, stress and anger management during caregivingSession 4: Relaxation and deep breathing techniques for stress control and psychological adjustmentTeaching Methods:Methods used included interactive lectures, group discussions, role-playing, and Q&A sessionsEducational materials included PowerPoint slides and a printed booklet specifically developed for this study.Duration and Frequency:The program was conducted over four sessions.Each session lasted 60 to 90 minutes, delivered over two weeks (two sessions per week).Location of Intervention:Conducted in a dedicated education room at the orthopedic outpatient clinic of Sina Hospital, equipped with standard educational facilities (adequate lighting, comfortable seating, audiovisual equipment).Source of Educational Materials:All materials were developed by the research team and printed by the Publication and Printing Center of Tehran University of Medical Sciences.Nature of the Intervention:No medication, chemical substance, injection, or surgical procedure was used.The intervention was entirely non-pharmacological and non-invasive, focused solely on skill enhancement and psychological support for caregivers. Intervention 2: Control group: They did not receive any intervention. Yes - There is a plan to make this available What will be shared: Our study, which was designed to investigate the effect of a supportive education program on the caregiving stress and quality of life of caregivers of patients with hip fractures referred to the orthopedic department and clinic of Sina Hospital in Tehran, includes a set of valuable documents and files that can be shared in accordance with ethical principles. First, the questionnaires that the samples completed in two stages before the intervention and 14 days after the last training are the main treasure trove of our data. These questionnaires include demographic information, caregiver caregiving stress questionnaires, and the SF-36 quality of life questionnaire, which were measured with standard tools. If we hide the identities of the individuals with anonymous coding, these data can be fully available to other researchers to conduct further analyses or compare the results with similar studies. In addition, the data analysis file prepared in SPSS software, which shows our statistical results; from means and standard deviations to tests such as t-tests. This file can also be shared, but perhaps only parts of it will be made public. We will probably only share the raw, more detailed data with others upon formal request and approval from the ethics committee, because participant confidentiality is a red line for us. As for the educational content; the educational booklet that we used and because it is also going to be given to the control group after the study, it is completely ready to be shared. Imagine this content as a small library that can reach universities and other researchers and help train nurses. In general, we would like our data and findings to be shared with the world, but with caution and care, so that both science advances and the privacy of the samples is preserved. When: Access begins 6 months after results are published. To whom: Researchers working in academic institutions and industry Conditions: Our anonymized data is a treasure trove that we can share with caution. Researchers can use this data for statistical analyses, such as comparing means or examining correlations, or use educational documentation to design similar courses. All of this will be under the supervision of an ethics committee and with a commitment to confidentiality. To request access, they must provide a formal letter stating the purpose of the research, ethical approval from a reputable institution, and a commitment not to publish the raw data so that we can safely share this information with them. Where to obtain: To Dr. Golnar Ghane, the project's faculty executive, golnarghane@gmail.com How to obtain: In order for the documents or data files to reach the applicant, there are a few simple but important steps that need to be taken. Your request is like a letter that first reaches Dr. Golnar Ghane, the study administrator; simply apply via email or by calling the Tehran University of Medical Sciences School of Nursing and Midwifery. She will review your request—including the purpose of use and ethical documents—and if everything is complete, she will give initial approval. This usually takes a week. Next, the data must be anonymized; for example, student names and codes are removed to maintain privacy. This step, which is carried out by the research team, takes about 5 to 7 days. Then, the Ethics Committee of Tehran University of Medical Sciences takes a final look to make sure everything is in accordance with the principles—this also takes another week. Finally, the files (such as questionnaires or educational content) will be sent to you via email or secure drive. Overall, if your application is complete and flawless, it will take about 2 to 3 weeks for this treasure to reach you. Comments:
public Golnar Ghane
Dr. Mirkhani St. (East Nusrat), Tawheed Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 Golnarghane@gmail.com Tehran University of Medical Sciences scientific Golnar Ghane
Dr. Mirkhani St. (East Nusrat), Tawheed Square
Tehran Iran (Islamic Republic of) 1419733171 +98 21 6692 7171 Golnarghane@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) being a relative or family member of the patient actively participating in the home care of a hip fracture patient demonstrating a willingness to engage in the study being at least 18 years of age possessing literacy skills having no psychological or neurological disorders 18 years no limit Both lack of caregiver cooperation participation in similar educational programs the occurrence of family crises during the study voluntary withdrawal from the study, S72.0 Fracture of head and neck of femur Lifestyle N/A Intervention group: In this study, the intervention involved a supportive educative program for caregivers of patients with hip fracture. No medications, chemical agents, surgeries, or invasive procedures were involved. Therefore, only a detailed description of the educational intervention is provided:Content of the Intervention:The supportive educational program was structured around two main components:Home care training for patients post-hip fracture surgeryProblem-focused coping skills training (effective communication, anger management, deep breathing techniques)Program Components:Session 1: Basic home care principles post-hip fracture surgery (patient transfer, pressure sore prevention, early mobilization assistance, nutritional advice)Session 2: Prevention of secondary complications (infection, thrombosis, fall prevention) and home safety strategiesSession 3: Effective communication skills, stress and anger management during caregivingSession 4: Relaxation and deep breathing techniques for stress control and psychological adjustmentTeaching Methods:Methods used included interactive lectures, group discussions, role-playing, and Q&A sessionsEducational materials included PowerPoint slides and a printed booklet specifically developed for this study.Duration and Frequency:The program was conducted over four sessions.Each session lasted 60 to 90 minutes, delivered over two weeks (two sessions per week).Location of Intervention:Conducted in a dedicated education room at the orthopedic outpatient clinic of Sina Hospital, equipped with standard educational facilities (adequate lighting, comfortable seating, audiovisual equipment).Source of Educational Materials:All materials were developed by the research team and printed by the Publication and Printing Center of Tehran University of Medical Sciences.Nature of the Intervention:No medication, chemical substance, injection, or surgical procedure was used.The intervention was entirely non-pharmacological and non-invasive, focused solely on skill enhancement and psychological support for caregivers. Control group: They did not receive any intervention Caregivers' caregiving pressure questionnaire (CBI). Timepoint: Before the start of the intervention and 14 days after the last day of the intervention. Method of measurement: The Caregiver Burden Inventory (CBI) consists of 24 items, which were developed by Novak & Guest in 1989 to measure objective and subjective caregiving burden, and it measures subjective caregiving burden with greater emphasis. This questionnaire consists of five subscales: time-related caregiving burden (questions 1 to 5), developmental caregiving burden (questions 6 to 10), physical caregiving burden (questions 11 to 14), social caregiving burden (questions 15 to 19), and emotional caregiving burden (questions 20 to 24). The caregivers' responses will be measured on a 5-point Likert scale (completely false to completely true), so that the samples will choose one of the following options for each question: completely false (score 1), false (score 2), somewhat true (score 3), true (score 4), and completely true (score 5). Accordingly, the scores obtained from this questionnaire will range from 24 to 120, and according to the mean and standard deviation of the total caregiving stress scores, scores of 24 to 39 will be considered mild caregiving stress, 40 to 71 moderate caregiving stress, and 72 to 120 severe caregiving stress (Abbasi et al., 2012). SF-36 Quality of Life Questionnaire. Timepoint: Before the start of the intervention and 14 days after the last day of the intervention. Method of measurement: The SF-36 Quality of Life Questionnaire has 36 items divided into three levels: 1- Questions 2- Eight scales, each of which is obtained by combining 2 to 10 questions, which are: physical function, physical limitation, physical pain, general health, vitality, social function, mental problems, and mental health 3- A summary bi-scale that is formed by combining the scales in the form of physical health (physical function, physical limitation, physical pain, general health) and mental health (social function, mental problems, mental health, and vitality). Each dimension of the questionnaire measures different options in accordance with the questions, which, depending on its needs, include questions with two options (yes, no) and six options (all the time, most of the time, most of the time, sometimes, sometimes, never). The scores of each subscale vary from 0 to 100, with 0 reporting the worst and 100 reporting the best situation in the subscale in question. The score of each dimension will be determined by the scores of the headings in that dimension. The score for each subscale is calculated separately and averaged. The score is given as a percentage of health in that dimension. To calculate the total questionnaire, the sum of the scores for each subscale is divided by 8, and the resulting number should be between 0 and 100. The lowest score in this questionnaire is zero and the highest is 100, with zero representing the worst and 100 representing the best on the overall scale, and the closer the average score is to zero, the lower the quality of life will be, and the closer the average score is to 100, the higher the quality of life will be (55). Tehran University of Medical Sciences Approved 2024-07-06 Sina Hospital - Tehran University of Medical Sciences (Research Ethics Committee) Room 604, 6th Floor, Central Building, Tehran University of Medical Sciences, Qods Street and Keshavarz Boulevard Intersection, Tehran University, Secretariat of the Ethics Committee in Biomedical Research tehran Tehran Iran (Islamic Republic of)