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IRCT20191231045967N1 IRCT 2020-02-11 Yazd University of Medical Sciences Determining the effect of vitamin D3 and positive group counseling with lifestyle changes in premenstrual women of reproductive age Survey the effect of vitamin D3 tablet intake, positivism group consulting with changing in life style in the treatment of premenstrual syndrome in women 2020-02-20 anticipated 84 Complete https://irct.ir/trial/45331 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple random sampling In this way, we first obtain the list of all members, then assign a score to each of them, and select the required number using the random number table. 3 Women's premenstrual syndrome. Intervention 1: Intervention group: Intervention group consuming vitamin D3, with a criterion and after determining 25 hydroxyvitamin D level, subjects with serum level less than 30 ng / ml will be included in the study. Each person is given 6 capsules of vitamin D 50000, D3 to take 1 dose per week for 6 weeks. After 6 weeks of administration and determination of 25-جhydroxytryptamine serum level, the physician is instructed to take one vitamin D within 4 weeks. 50,000 units manufactured by the pharmaceutical company are disposed of and re-measured at the end of the intervention. The premenstrual syndrome form is completed before the study, at 6 weeks and 10 weeks after the intervention. Satisfaction with intervention methods is assessed in weeks 6 and 10. Intervention 2: Intervention group: In the intervention group, 6 group sessions will be held online because of covid 19 pandemic once a week for 90 minutes in a positive-group group. After selecting the women for the meetings, we select the days of the two groups' meetings as suggested by the women on two different days of the week so that the two groups receiving the consultation do not interact with each other. , Second session, gratitude meeting, third session, constructive active response, fourth session, counting blessings, fifth session, sense of taste, sixth session, preservation of therapeutic effects. Pre-menstrual syndrome form before study, 6 weeks intervention and Week 10 was completed after the intervention. Satisfaction with intervention method is assessed in weeks 6 and 10. Intervention 3: Control group: Lifestyle group sessions on appropriate physical activity, weight and fitness control, healthy eating, menstrual mental health, tobacco harm and familiarity with early detection methods of common female cancer (breast and cervical cancer) and during 6 sssions for 2 groups are held in two days, 6 sessions online because of covid 19 pandemic. The premenstrual syndrome form is completed before the study, at 6 weeks and 10 weeks after the intervention. Satisfaction with intervention method is assessed in weeks 6 and 10. 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 I haven't decided yet to finish the study.
public Dr. Tahmineh Faraj Khoda
Fars, Arsanjan city, Imam Khomeini town
Yazd Iran (Islamic Republic of) 7376187999 009843527244 maryam.mahmoodi8874@gmail.com Yazd University of Medical Sciences scientific Dr. Tahmineh Faraj Khoda
Fars, Arsanjan city, Imam Khomeini town
Yazd Iran (Islamic Republic of) 7376187999 009843527244 maryam.mahmoodi8874@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) Being a resident of Rafsanjan city No history of treatment or depression or anxiety disorder No history of treatment or eating disorder No history of treatment or anemia disorder No history of treatment or thyroid disorder No history of treatment or presence of diabetes Not taking birth control pills for medical reasons Not taking any herbal medicine or medicine that affects premenstrual syndrome Lack of treatment with psychiatric drugs and other non-pharmacological methods Lack of treatment with other non-medicinal methods Having two consecutive menstrual cycles a year with symptoms of premenstrual syndrome with at least five symptoms, one of which are mood disorders, which begin in the second half of the menstrual cycle and improve after menstruation, according to the self-report. Having at least a 30% increase in symptom severity within 5 days before menstruation based on the PMS Willingness to continue collaborating on tasks for 6 weeks Failure to participate in another related study until the expiration of the current study 20 years 40 years Female Severe form of premenstrual syndrome with a score of 35 and more from the premenstrual syndrome calendar N94.3 Premenstrual tension syndrome Treatment - Drugs Behavior Lifestyle Intervention group: Intervention group consuming vitamin D3, with a criterion and after determining 25 hydroxyvitamin D level, subjects with serum level less than 30 ng / ml will be included in the study. Each person is given 6 capsules of vitamin D 50000, D3 to take 1 dose per week for 6 weeks. After 6 weeks of administration and determination of 25-جhydroxytryptamine serum level, the physician is instructed to take one vitamin D within 4 weeks. 50,000 units manufactured by the pharmaceutical company are disposed of and re-measured at the end of the intervention. The premenstrual syndrome form is completed before the study, at 6 weeks and 10 weeks after the intervention. Satisfaction with intervention methods is assessed in weeks 6 and 10. Intervention group: In the intervention group, 6 group sessions will be held online because of covid 19 pandemic once a week for 90 minutes in a positive-group group. After selecting the women for the meetings, we select the days of the two groups' meetings as suggested by the women on two different days of the week so that the two groups receiving the consultation do not interact with each other. , Second session, gratitude meeting, third session, constructive active response, fourth session, counting blessings, fifth session, sense of taste, sixth session, preservation of therapeutic effects. Pre-menstrual syndrome form before study, 6 weeks intervention and Week 10 was completed after the intervention. Satisfaction with intervention method is assessed in weeks 6 and 10. Control group: Lifestyle group sessions on appropriate physical activity, weight and fitness control, healthy eating, menstrual mental health, tobacco harm and familiarity with early detection methods of common female cancer (breast and cervical cancer) and during 6 sssions for 2 groups are held in two days, 6 sessions online because of covid 19 pandemic. The premenstrual syndrome form is completed before the study, at 6 weeks and 10 weeks after the intervention. Satisfaction with intervention method is assessed in weeks 6 and 10. 1-Mean premenstrual syndrome scores, 2- Satisfaction with intervention methods. Timepoint: 1-ّFor premenstrual syndrome before the intervention, complete the sixth week of the intervention and finish the tenth week.2- At the end of 6 and 10 weeks. Method of measurement: 1-Premenstrual Syndrome Screening Tool , 2-Satisfaction tool. Yazd University of Medical Sciences Approved 2019-12-31 Ethics Committee of Shahid Sadoughi University of Medical Sciences Fars, Arsanjan city, Imam Khomeini town, Modarres Alley 4 yazd Yazd Iran (Islamic Republic of)