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IRCT20210704051787N1 IRCT 2022-01-21 Zanjan University of Medical Sciences The effect of Iranian principles of Hefz - Alsehe on the symptoms of premenstrual syndrome  The effect of motivational interview focused on some principles of Hefz – Alsehe in Iranian medicine on the physical and psychological symptoms of premenstrual syndrome 2022-01-27 anticipated 50 Complete https://irct.ir/trial/57342 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling will be performed by the simple and allocation will be blocked randomization. For this purpose, four-person blocks will be defined to determine the two groups of intervention and control. The sample size in the two groups is 50 people, so the allocation of people in both groups by random selection of 13 four-person blocks (52 people) will be from the following blocks. Each block will be selected using a random number table. 1- AABB 2- BBAA 3- ABAB 4- BABA 5- ABBA 6- BAAB. N/A Condition 1: Premenstrual syndrome. Condition 2: Quality of life. Intervention 1: Intervention group: General instructions of Iranian medicine on the three principles of physical activity, eating & drinking, and sleep managment will be given to the participants in a written form, one week before starting the motivational interview sessions. Participants will be encouraged to assess their own positive/negative behaviors on the basis of these principles before starting motivational interview sessions. Motivational interview sessions will be held individually and virtually in five consecutive weekly sessions. The topics are as follows: Determining the rules; defining the change stages; describing a typical day and discussing it; evaluating the positive & negative dimensions of behaviors; identifying personal values; discovering conflict between values and behaviors; identifying, reinforcing, and invoking transformational dialogue; improvement the sense of self-efficacy; setting the goal and plan of change in behaviors of physical activity, eating & drinking, and sleep managment. The maximum time of each session will be 45 minutes. Intervention 2: Control group: Participants in this group will not receive any intervention. 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 There is no further information
public Robab Naseri
Zanjan University of Medical Sciences, Gavazang Road, Zanjan, Iran
Zanjan Iran (Islamic Republic of) 4515613191 +9824333549370 naseri.robab@yahoo.com Zanjan University of Medical Sciences scientific Dr Roghieh Kharaghani
Zanjan University of Medical Sciences, Gavazang Road
Zanjan Iran (Islamic Republic of) 4515613191 +98 24 3314 8300 r.kharaghani@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Willing to participate in the study Aged 18-42 years Regular menstruation with an interval of 21-35 days and duration of 3-10 days Experience of premenstrual syndrome according to the premenstrual symptoms screening tool Body Mass Index of 18.5 to 29.9 kg / m2 Access and ability to use social network 18 years 42 years Female Presence of stressors (e.g. the death of a loved person within the last three months) Medication or taking hormones to treat or relieve symptoms Previous history of illness depression under treatment N94.3 Premenstrual tension syndrome Lifestyle N/A Intervention group: General instructions of Iranian medicine on the three principles of physical activity, eating & drinking, and sleep managment will be given to the participants in a written form, one week before starting the motivational interview sessions. Participants will be encouraged to assess their own positive/negative behaviors on the basis of these principles before starting motivational interview sessions. Motivational interview sessions will be held individually and virtually in five consecutive weekly sessions. The topics are as follows: Determining the rules; defining the change stages; describing a typical day and discussing it; evaluating the positive & negative dimensions of behaviors; identifying personal values; discovering conflict between values and behaviors; identifying, reinforcing, and invoking transformational dialogue; improvement the sense of self-efficacy; setting the goal and plan of change in behaviors of physical activity, eating & drinking, and sleep managment. The maximum time of each session will be 45 minutes. Control group: Participants in this group will not receive any intervention. Physical and psychological symptoms of premenstrual syndrome. Timepoint: Before the intervention, immediately after the intervention and three months after the last counseling. Method of measurement: Premenstrual Symptoms Screening Tool PSST. ًQuality of life. Timepoint: Before the intervention, immediately after the intervention and three months after the last counseling. Method of measurement: Short form of quality of life questionnaire SF- 12. Physical activity. Timepoint: Before the intervention, immediately after the intervention and three months after the last counseling. Method of measurement: Sharkey Physical Activity Index. Lifestyle related to eating behavior. Timepoint: Before the intervention, immediately after the intervention and three months after the last counseling. Method of measurement: Weight Efficacy Lifestyle Questionnaire. Sleep hygiene. Timepoint: Before the intervention, immediately after the intervention and three months after the last counseling. Method of measurement: Sleep Hygiene Index. Dysmenorrhea. Timepoint: Before the intervention, immediately after the intervention and three months after the last counseling. Method of measurement: Numerical analog scale. Zanjan University of Medical Sciences Approved 2021-08-24 The ethics committee of Zanjan University of Medical Sciences The ethics committee of Zanjan University of Medical Sciences, First floor, Northside Azadi, Zanjan zanjan Zanjan Iran (Islamic Republic of)