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IRCT20170705034914N1 IRCT 2019-09-30 Shahroud University of Medical Sciences The effect of peer education on menopausal symptoms The effect of peer education on menopausal symptoms in menopausal women 2019-10-07 anticipated 120 Complete https://irct.ir/trial/41792 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: , Randomization description: In this study, the randomization unit will be individual. Block randomization is going to be used for randomization. 120 samples will randomly be divided into control and intervention groups in 30 blocks of 4(Including 2 participants in intervention group and 2 participants in control group), based on the random numbers that will be produced using website https://www.sealedenvelope.com/simple -randomizer. (60 participants in intervention group and 60 participants in control group). Using the central method, the allocation sequence will be concealed. The allocation sequence will be performed with the help of researcher assistance 1. At each center, researcher's assistance (2, 3, and 4) will register eligible individuals, and by contacting with the researcher assistance 1, Individuals, as they will be enrolled in the study, will also enter to a central list and assign to target groups. N/A Menopause. Intervention 1: Intervention group: In this study, intervention is going to be performed at two stages. The first stage will be selecting the peer group and educating them and the second stage, performing the intervention. At the stage of selecting the peers, six menopausal women (2 peers from each center), who will have some characteristics such as ability to run educational sessions, willingness to cooperate with the researcher, have appropriate social communications, having at least high school degree and interest in leading the group will be selected by the researcher as the trainers of the peer group. During 4 sessions (2 hours twice a week for duration of 2 week), selected peers who will be educated by the researcher about the importance and advantages of peer education, menopause, menopausal symptom and the methods of confronting and coping with it.Education will be performed using speech, question and answer with the help of learn assist tools (slides, images, etc.). After each educational session is going to be completed, the participants will exercise the trained items in the presence of the researcher using role play method. at the second stage, 60 participants for the peer education group will be divided into six groups of 10 and each of the selected peers will be allocated to educate one of the divisions; educating the peers is going to be performed during 4 educational sessions (2 hours once a week for duration of 4 week ). The intervention group, In addition to services that will be provided in health centers, will receive peer education. Intervention 2: Control group: Sixty menopausal women who will be referred to health centers in the control group will receive no intervention. They will receive only routine services and train is going to be provided at health centers. 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 Leila Mollaahmadi
1st floor, unit 2, No.122, 206 Eastern Ave., Tehran pars 3rd Sq.
Tehran Iran (Islamic Republic of) 1655716866 +98 21 7738 0715 ahmadileila49@yahoo.co.uk Shahroud University of Medical Sciences scientific Leila Mollaahmadi
1st floor, unit 2, No.122, 206 Eastern Ave., Tehran pars 3rd Sq.
Tehran Iran (Islamic Republic of) 1655716866 +98 21 7738 0715 ahmadileila49@yahoo.co.uk Shahroud University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Having a health record at a health care center Having at least the elementary school literacy Being married and having sex Having symptoms of menopause At least one year and up to 5 years after menopause Menopause occurs naturally Having Iranian nationality Having mental and physical health Voluntary participation and written consent 45 years 60 years Female Treated with hormonal drugs to relieve menopausal symptoms Being addicted to cigarette. drugs and alcohol Having mental, neurological and cancer diseases Other Lifestyle Intervention group: In this study, intervention is going to be performed at two stages. The first stage will be selecting the peer group and educating them and the second stage, performing the intervention. At the stage of selecting the peers, six menopausal women (2 peers from each center), who will have some characteristics such as ability to run educational sessions, willingness to cooperate with the researcher, have appropriate social communications, having at least high school degree and interest in leading the group will be selected by the researcher as the trainers of the peer group. During 4 sessions (2 hours twice a week for duration of 2 week), selected peers who will be educated by the researcher about the importance and advantages of peer education, menopause, menopausal symptom and the methods of confronting and coping with it.Education will be performed using speech, question and answer with the help of learn assist tools (slides, images, etc.). After each educational session is going to be completed, the participants will exercise the trained items in the presence of the researcher using role play method. at the second stage, 60 participants for the peer education group will be divided into six groups of 10 and each of the selected peers will be allocated to educate one of the divisions; educating the peers is going to be performed during 4 educational sessions (2 hours once a week for duration of 4 week ). The intervention group, In addition to services that will be provided in health centers, will receive peer education. Control group: Sixty menopausal women who will be referred to health centers in the control group will receive no intervention. They will receive only routine services and train is going to be provided at health centers Vasomotor symptoms. Timepoint: Before the intervention , immediately after the intervention and one month after the intervention. Method of measurement: Women's Health Questionnaire (WHQ). Somatic symptoms. Timepoint: Before the intervention , immediately after the intervention and one month after the intervention. Method of measurement: Women's Health Questionnaire (WHQ). Sexual problems. Timepoint: Before the intervention , immediately after the intervention and one month after the intervention. Method of measurement: Women's Health Questionnaire (WHQ). Anxiety/fear. Timepoint: Before the intervention , immediately after the intervention and one month after the intervention. Method of measurement: Women's Health Questionnaire (WHQ). Memory / concentration. Timepoint: Before the intervention , immediately after the intervention and one month after the intervention. Method of measurement: Women's Health Questionnaire (WHQ). Sleep problems. Timepoint: Before the intervention , immediately after the intervention and one month after the intervention. Method of measurement: Women's Health Questionnaire (WHQ). Depressed mood. Timepoint: Before the intervention , immediately after the intervention and one month after the intervention. Method of measurement: Women's Health Questionnaire (WHQ). Attractiveness. Timepoint: Before the intervention , immediately after the intervention and one month after the intervention. Method of measurement: Women's Health Questionnaire (WHQ). Shahroud University of Medical Sciences Approved 2017-07-19 Ethics Committee of Shahroud University of Medical Sciences HaftTir Sq., Central building of Shahroud University of Medical Sciences and Health Services Shahroud Semnan Iran (Islamic Republic of)