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IRCT20250811066817N1 IRCT 2025-08-14 Tarbiat Modares University The impact of implementing the empowerment model on the quality of life and self-management behaviors of postmenopausal women. The Impact of family-centered empowerment model based on healthy lifestyle on quality of life and self-management behavior of post menopause women 2025-08-23 anticipated 60 Complete https://irct.ir/trial/85483 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: First, one district will be randomly selected from the four districts (north, south, east, and west) of Jahrom city. After obtaining permission from Tarbiat Modares University and presenting an official introduction letter to the Department of Education in Jahrom, two schools will be selected (one school for the intervention group and one school for the control group). Upon presenting the introduction letter to the school principals, they will be asked to identify mothers aged over 45 years. With the cooperation of the school principals, written invitations will be sent to these mothers to attend a meeting at the school. In this meeting, after being informed about the study procedure, those who agree to participate will be asked to sign a written informed consent form. This process will be carried out in both the intervention and control groups. Sampling will be purposeful, based on the characteristics of the target population. Unit of randomization: Cluster (school) — one school will be assigned to the control group and one school to the intervention group, Blinding description: In this study, outcome assessors and data analysts are blinded to group allocation to minimize bias in data collection and analysis. Participants are aware of their group assignments due to the educational nature of the intervention. Blinding of participants was not feasible because of the nature of the educational intervention. N/A menopause. Intervention 1: Intervention Phase: Based on the analysis of pre-test data, which leads to identifying resources, limitations, needs, strengths, and weaknesses of menopausal women regarding a healthy lifestyle and menopause, the content of the empowerment program will be revised and implemented for them according to the four steps of the family-centered empowerment model. Description of the implementation of the four steps of the family-centered empowerment model: Step One: Perceived Threat — This consists of two parts: perceived severity and perceived susceptibility.Perceived Susceptibility: The individual's recognition of the likelihood of developing the related disease or chronic condition; the person understands their situation and defines health correctly in relation to the disease, feels at risk, and considers the possibility of becoming affected. Perceived Severity: The individual's awareness and understanding of the problem, disease, or chronic condition; recognizing the dangers and complications involved, understanding its seriousness, and feeling threatened by it. Content of perceived susceptibility sessions: Introduction to the female reproductive system and personal hygiene. Explanation of menopause, physiological changes in middle-aged women, symptoms, and related complications. The importance of a healthy lifestyle, including understanding a healthy diet: discussing eating patterns and habits, calculating Body Mass Index (BMI), understanding the food pyramid and the value of each group, recognizing sources of Vitamin D, calcium, Vitamin E and its effect on sleep quality, and the importance of balanced intake. The importance of a healthy lifestyle, such as recognizing the importance of exercise and physical activity and the benefits of exercise; regular walking at a certain time of day improves glucose metabolism, reduces body fat, lowers blood pressure, and more. Relaxation during menopause; learning how to communicate with others, benefits of relaxation programs, and managing stress and anxiety during menopause. Enhancing spirituality; introducing spiritual customs and habits that promote the spiritual dimension. Content of perceived severity sessions: Observing hygiene of the female reproductive system during middle age, maintaining personal hygiene, and preventing vaginal dryness; wearing cotton and lightweight clothing during hot flashes and sweating. Maintaining and observing a healthy lifestyle, including following a healthy diet and the consequences of not doing so (reducing unhealthy eating habits like less consumption of bloating foods, eating according to the food pyramid, preventing visceral abdominal fat, etc.). Engaging in exercise and physical activity, and explaining the consequences of inactivity (e.g., regular exercise or walking for at least 30 minutes daily, pelvic floor muscle training (PFMT) to improve urinary incontinence (UI), increase pelvic floor muscle strength and endurance, and the positive effect of aerobic exercises on reducing anxiety, depression, and improving sleep quality). Educating about menopause’s effects on various body systems and providing solutions; menopause’s impact on increased risk of metabolic syndrome (feeling of swelling and puffiness), cardiovascular diseases, osteoporosis, etc. Maintaining calm during menopause; establishing healthy and intimate communication with others, avoiding isolation, using relaxation programs to manage stress and anxiety, and educating on sleep hygiene. Enhancing spirituality by observing spiritual customs and habits based on the study participants’ own habits and tendencies. Step Two: Self-Efficacy: To enhance self-efficacy and improve necessary skills, sessions are conducted using problem-solving group discussions. The educational content includes 2 to 3 group discussion sessions with 5 to 7 menopausal women based on problem-solving stages. The session contents include: Problem Identification: Any symptoms and complications caused by menopause such as hot flashes, night sweats, mood changes, decreased marital satisfaction, sleep disorders, etc. Problem Analysis: Objectives are defined based on the causes and nature of the problem. For example, regarding hot flashes and night sweats, daily bathing and wearing cotton, loose clothing are suggested. Offering Solutions: Discussion, review, and finding the problem-solving process and the best solutions to improve menopausal women's skills, such as managing diet, sleep and rest, daily physical activity, stress control, spirituality, and boosting confidence through the feeling “I can play a role in improving my condition,” etc. Selecting the Best Solution: Menopausal women, under the researcher’s supervision, discuss examples of their situations and what actions they would take to improve similar problems with others. The final session summarizes the previous sessions and answers any questions. Step Three: Self-Belief (Self-Esteem): This step is carried out through participatory education. Self-belief or self-esteem refers to the degree of approval, acceptance, and value a person feels toward themselves. In this phase, feedback on educational content is evaluated.Participants are asked to teach the educational content, which is provided to them at the end of each session in the form of educational cards, to an active family member (sister, mother, aunt, etc.).An active family member is one approved by the patient, who has responsibility and significant influence in family decisions, is willing to cooperate, literate, and able to assist the patient in knowledge, attitude, motivation, and performance, as well as to transfer the learned materials to other family members. The menopausal women also feel comfortable with this person.This teaching responsibility enhances their self-esteem and helps consolidate the education received regarding menopause-related issues, benefiting both the menopausal women and the family member receiving the education. The family member may either be currently facing these issues or will face them in the near future, which empowers them and encourages them to help themselves. Intervention 2: Control group: Since the control group is asked to complete the questionnaires at two stages—pre-test and post-test—during this period (while the intervention is being conducted for the experimental group), one of the personal hygiene topics, which is of interest to the majority, will be taught to them. Additionally, after the completion of the intervention and evaluation in the experimental group, the educational content will also be provided to the control group. Yes - There is a plan to make this available What will be shared: Statistical data is considered and can be shared after code insertion. When: Starting to access data from 2026. To whom: Access to the data is open to all interested individuals. Conditions: It is generalizable for training purposes to similar groups. Where to obtain: (https://modares.ac.ir/res/managements/library) Dr.Fatemeh Alhani(alhani_f@modares.ac.ir) How to obtain: A formal request can be made via email to Dr. Fatemeh Alhani (alhani_f@modares.ac.ir) or by visiting the Tarbiat Modares University Library website at (https://modares.ac.ir/res/managements/library) Comments: _
public Fatemeh Alhani
Jalal Al-Ahmad Highway, Tarbiat Modares University, School of Medicine, Building 1, Tehran, Iran.
Tehran Iran (Islamic Republic of) 14115331 +98 21 8288 3898 alhani_f@modares.ac.ir Tarbiat Modares University scientific Fatemeh Alhani
Jalal Al-Ahmad Highway, Tarbiat Modares University, School of Medicine, Building 1, Tehran, Iran.
tehran Iran (Islamic Republic of) 14115331 +98 21 8288 3898 alhani_f@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Willingness to participate in the study No history of hysterectomy or oophorectomy Natural menopause No history of cancer No severe mental or physical illness At least 12 months have passed since the last menstrual bleeding Empowerment score of 75 or less No use of hormone therapy, selective serotonin reuptake inhibitors, or selective estrogen receptor modulators in the past 6 months If the participant is illiterate, an active family member must have at least a middle school education No use of psychiatric medications or visits to a behavioral specialist in the past 6 months 45 years 65 years Female Lack of willingness to continue participation during the screening process Inability to complete the questionnaires Presence of an acute illness at the time of screening N95.1 Menopausal and female climacteric states Behavior Behavior Intervention Phase: Based on the analysis of pre-test data, which leads to identifying resources, limitations, needs, strengths, and weaknesses of menopausal women regarding a healthy lifestyle and menopause, the content of the empowerment program will be revised and implemented for them according to the four steps of the family-centered empowerment model. Description of the implementation of the four steps of the family-centered empowerment model: Step One: Perceived Threat — This consists of two parts: perceived severity and perceived susceptibility.Perceived Susceptibility: The individual's recognition of the likelihood of developing the related disease or chronic condition; the person understands their situation and defines health correctly in relation to the disease, feels at risk, and considers the possibility of becoming affected. Perceived Severity: The individual's awareness and understanding of the problem, disease, or chronic condition; recognizing the dangers and complications involved, understanding its seriousness, and feeling threatened by it. Content of perceived susceptibility sessions: Introduction to the female reproductive system and personal hygiene. Explanation of menopause, physiological changes in middle-aged women, symptoms, and related complications. The importance of a healthy lifestyle, including understanding a healthy diet: discussing eating patterns and habits, calculating Body Mass Index (BMI), understanding the food pyramid and the value of each group, recognizing sources of Vitamin D, calcium, Vitamin E and its effect on sleep quality, and the importance of balanced intake. The importance of a healthy lifestyle, such as recognizing the importance of exercise and physical activity and the benefits of exercise; regular walking at a certain time of day improves glucose metabolism, reduces body fat, lowers blood pressure, and more. Relaxation during menopause; learning how to communicate with others, benefits of relaxation programs, and managing stress and anxiety during menopause. Enhancing spirituality; introducing spiritual customs and habits that promote the spiritual dimension. Content of perceived severity sessions: Observing hygiene of the female reproductive system during middle age, maintaining personal hygiene, and preventing vaginal dryness; wearing cotton and lightweight clothing during hot flashes and sweating. Maintaining and observing a healthy lifestyle, including following a healthy diet and the consequences of not doing so (reducing unhealthy eating habits like less consumption of bloating foods, eating according to the food pyramid, preventing visceral abdominal fat, etc.). Engaging in exercise and physical activity, and explaining the consequences of inactivity (e.g., regular exercise or walking for at least 30 minutes daily, pelvic floor muscle training (PFMT) to improve urinary incontinence (UI), increase pelvic floor muscle strength and endurance, and the positive effect of aerobic exercises on reducing anxiety, depression, and improving sleep quality). Educating about menopause’s effects on various body systems and providing solutions; menopause’s impact on increased risk of metabolic syndrome (feeling of swelling and puffiness), cardiovascular diseases, osteoporosis, etc. Maintaining calm during menopause; establishing healthy and intimate communication with others, avoiding isolation, using relaxation programs to manage stress and anxiety, and educating on sleep hygiene. Enhancing spirituality by observing spiritual customs and habits based on the study participants’ own habits and tendencies. Step Two: Self-Efficacy: To enhance self-efficacy and improve necessary skills, sessions are conducted using problem-solving group discussions. The educational content includes 2 to 3 group discussion sessions with 5 to 7 menopausal women based on problem-solving stages. The session contents include: Problem Identification: Any symptoms and complications caused by menopause such as hot flashes, night sweats, mood changes, decreased marital satisfaction, sleep disorders, etc. Problem Analysis: Objectives are defined based on the causes and nature of the problem. For example, regarding hot flashes and night sweats, daily bathing and wearing cotton, loose clothing are suggested. Offering Solutions: Discussion, review, and finding the problem-solving process and the best solutions to improve menopausal women's skills, such as managing diet, sleep and rest, daily physical activity, stress control, spirituality, and boosting confidence through the feeling “I can play a role in improving my condition,” etc. Selecting the Best Solution: Menopausal women, under the researcher’s supervision, discuss examples of their situations and what actions they would take to improve similar problems with others. The final session summarizes the previous sessions and answers any questions. Step Three: Self-Belief (Self-Esteem): This step is carried out through participatory education. Self-belief or self-esteem refers to the degree of approval, acceptance, and value a person feels toward themselves. In this phase, feedback on educational content is evaluated.Participants are asked to teach the educational content, which is provided to them at the end of each session in the form of educational cards, to an active family member (sister, mother, aunt, etc.).An active family member is one approved by the patient, who has responsibility and significant influence in family decisions, is willing to cooperate, literate, and able to assist the patient in knowledge, attitude, motivation, and performance, as well as to transfer the learned materials to other family members. The menopausal women also feel comfortable with this person.This teaching responsibility enhances their self-esteem and helps consolidate the education received regarding menopause-related issues, benefiting both the menopausal women and the family member receiving the education. The family member may either be currently facing these issues or will face them in the near future, which empowers them and encourages them to help themselves. Control group: Since the control group is asked to complete the questionnaires at two stages—pre-test and post-test—during this period (while the intervention is being conducted for the experimental group), one of the personal hygiene topics, which is of interest to the majority, will be taught to them. Additionally, after the completion of the intervention and evaluation in the experimental group, the educational content will also be provided to the control group. Empowerment: Mean empowerment score of postmenopausal women. Timepoint: Empowerment level: before the intervention; 7 to 10 days after the end of the intervention. Method of measurement: Questionnaire of Empowerment for Postmenopausal Women (Researcher-made questionnaire); the tool was developed by the researcher; content validity was assessed by experts, and reliability was evaluated in a pilot sample. Self management behavior: Mean self-management behavior score of postmenopausal women. Timepoint: The level of self-management behavior: Before the intervention; one and a half months after the end of the intervention. Method of measurement: The Self-Management Behavior Assessment Questionnaire for Menopausal Women (researcher-made questionnaire), which contains 88 questions, was developed by the researcher; its content validity was reviewed by experts, and its reliability was assessed in a pilot sample. Quality of Life of Postmenopausal Women: Mean quality of life score of postmenopausal women. Timepoint: Quality of Life Level: Before the intervention; one and a half months after the end of the intervention. Method of measurement: The Menopause-Specific Quality of Life Questionnaire, which contains 29 items. Tarbiat Modares University Approved 2025-07-28 Ethics committe of Tarbiat Modares University Jalal Al-Ahmad Highway, Tarbiat Modares University, School of Medicine, Building 1, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)