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IRCT20100414003706N34 IRCT 2019-06-19 Tabriz University of Medical Sciences Effect of Web-Based counseling on Premenstrual Syndrome Effect of Web-Based Counseling with Cognitive-Behavioral Approach on Premenstrual Syndrome: a randomized controlled trial 2019-06-22 anticipated 92 Complete https://irct.ir/trial/38394 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants will be allocated in a 1:1 ratio to counselling or control groups. A computerized program will be used for stratified block randomization with randomly varied block sizes of four and six, stratify for severity of the syndrome (with or without PMDD). Consecutively numbered opaque sealed envelopes will be used to conceal the allocation sequence. The sequence generation and the envelop preparation will be done by a person not involved in the participant recruitment, intervention implementation, or collection or analysis of data. N/A Premenstrual Syndrome. Intervention 1: Intervention group: Web-based cognitive-behavior counselling (through the Learning Management System (MOODLE) of Tabriz University of Medical Sciences) including 14 modules over 8 consecutive weeks, one module for the first (introduction session about premenstrual syndrome (PMS) and its etiology) and the eighth (review of the previous sessions and prevention of relapse) sessions and two parallel (concurrent) modules (modules C1 to C6 about cognitive strategies and B1 to B6 regarding suggestions about behavior changes in lifestyle) for the other sessions. For modules designed for the second to seventh weeks, an approximate working time will be 5 hours per week. Contents of the modules have been approved by the study team including specialists in reproductive health and in psychology and cognitive-behavior therapy. The sessions will be guided by a MSc student in counselling in midwifery trained on cognitive-behavior counselling and will regularly be supervised by the psychologist. Before the sessions, participants will receive detailed instructions on how to use the information, importance of exercises and how to deal with any technical obstacles. Every week at the time of publishing new content in the e-learning management system, an email and a SMS will be sent to the individuals as reminders. There will be also the possibility of online commentary so users can submit their questions and problems online on the site. Participants will give weekly feedback. If a participant does not send her feedback, she will receive an email reminder, and if she does not respond to this reminder, they will be reminded by telephone. Contents of the modules for the second to seventh weeks will be C1: the role of thoughts and its relationship with emotions and behavior (cognitive triangle), and B1: the relationship between stress and PMS and learning of relaxation techniques for the second week, C2: moving to a specific field of PMS and B2: interdependence between nutrition, exercise and PMS for the third week, C3: the restructuring of dysfunctional perceptions and B3: integrating sport into daily life by motivational plans and strategies for the fourth week , C4: PMS specific myths and the use of cognitive strategies learned and B4: a balanced diet and an implementation in routine life for the fifth week, C5: effective thoughts and the development of new evaluations and B5: the effects of stress-related errors in reasoning for the sixth week, C6: PMS-specific behavior (the use of health care, support, communication) and B6: implementation of positive activities in routine daily life for the seventh week. Intervention 2: Control group: nothing. Yes - There is a plan to make this available What will be shared: All deidentified IPD can be shared. When: Starting soon after publication of the study results for ten years To whom: Data will be available for researchers working in academic institutions, as well as to chief editor and reviewers of the submitted manuscript. Conditions: The data will be available to researchers upon request and submission of the proposal to perform meta-analysis using IPD. Also, in exceptional cases, data will be made available to chief-editor of the journals for checking. Where to obtain: Refer to the email addresses (borjisanam@gmail.com, alizades@tbzmed.ac.ir). How to obtain: The requests should be sent by email and data will be available within two week. Comments:
public Sanam Borji Navan
Nursing & Midwifery Faculty, South Shariati Street
Tabriz Iran (Islamic Republic of) 5137975846 +98 13 4422 7002 Borjisanam@gmail.com Tabriz University of Medical Sciences scientific Sakineh Mohammad-Alizadeh Charandabi
Faculty of Nursing & Midwifery , South Shariati Street
Tabriz Iran (Islamic Republic of) 5137975846 +98 41 3479 6770 Alizades@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Healthy women aged 18-35 years Resident in governmental or non-governmental dormitories of Tabriz University of Medical Sciences Regular menstrual periods of 25 to 35 days over the past 6 months Having moderate or severe premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD), based on the DRSP questionnaire filled in two following cycles Good cooperation in filling the questionnaires at the preliminary stage of study (before randomization) Having experience in using Internet Regular access to Internet during study period Having a phone number for follow-up 18 years 35 years Female Being a professional athlete Pregnancy or the first postpartum year Breast-feeding Having severe depression (score 29 or higher on Beck Depression Inventory) Having a history of severe depression, anxiety or eating disorders in the past two years, self-report Drug use or history of drug use during the last two years, self-report Use of antidepressants, benzodiazepines, anticancer drugs, oral contraceptives or hormones in the past three months, self-report Having chronic diseases (such as epilepsy, or severe digestive, cardiovascular, kidney, or gonadal disorders), self-report Occurrence of a very stressful event in the past six months, such as: separation of parents, death of first degree family members, self-report History of major psychiatric disorders (psychosis, bipolar disorder, suicide attempt) Having some gynecological problems (hysterectomy, Ooforectomy, female cancer, polycystic ovary syndrome, endometriosis, infertility) N94.3 Premenstrual tension syndrome Behavior Treatment - Other Intervention group: Web-based cognitive-behavior counselling (through the Learning Management System (MOODLE) of Tabriz University of Medical Sciences) including 14 modules over 8 consecutive weeks, one module for the first (introduction session about premenstrual syndrome (PMS) and its etiology) and the eighth (review of the previous sessions and prevention of relapse) sessions and two parallel (concurrent) modules (modules C1 to C6 about cognitive strategies and B1 to B6 regarding suggestions about behavior changes in lifestyle) for the other sessions. For modules designed for the second to seventh weeks, an approximate working time will be 5 hours per week. Contents of the modules have been approved by the study team including specialists in reproductive health and in psychology and cognitive-behavior therapy. The sessions will be guided by a MSc student in counselling in midwifery trained on cognitive-behavior counselling and will regularly be supervised by the psychologist. Before the sessions, participants will receive detailed instructions on how to use the information, importance of exercises and how to deal with any technical obstacles. Every week at the time of publishing new content in the e-learning management system, an email and a SMS will be sent to the individuals as reminders. There will be also the possibility of online commentary so users can submit their questions and problems online on the site. Participants will give weekly feedback. If a participant does not send her feedback, she will receive an email reminder, and if she does not respond to this reminder, they will be reminded by telephone. Contents of the modules for the second to seventh weeks will be C1: the role of thoughts and its relationship with emotions and behavior (cognitive triangle), and B1: the relationship between stress and PMS and learning of relaxation techniques for the second week, C2: moving to a specific field of PMS and B2: interdependence between nutrition, exercise and PMS for the third week, C3: the restructuring of dysfunctional perceptions and B3: integrating sport into daily life by motivational plans and strategies for the fourth week , C4: PMS specific myths and the use of cognitive strategies learned and B4: a balanced diet and an implementation in routine life for the fifth week, C5: effective thoughts and the development of new evaluations and B5: the effects of stress-related errors in reasoning for the sixth week, C6: PMS-specific behavior (the use of health care, support, communication) and B6: implementation of positive activities in routine daily life for the seventh week. Control group: nothing Symptoms of premenstrual syndrome. Timepoint: Daily record of severity of symptoms for two menstrual cycle at two stages, first at the baseline (before randomization) and just after completion of the intervention. Method of measurement: Daily Record of Severity of Problems chart (DRSP). Quality of life at luteal phase of menstruation. Timepoint: At the first or second day of menstrual cycle at two stages (at the cycle prior to the randomization and at the cycle just after completion of intervention). Method of measurement: Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF). Quality of life follicular phase of the menstrual. Timepoint: At the 11th-13th day of menstrual cycle at two stages (at the cycle prior to the randomization and at the cycle just after completion of intervention). Method of measurement: Q-LES-Q-SF. Menstrual Attitude. Timepoint: At the first or second day of menstrual cycle at two stages (at the cycle prior to the randomization and at the cycle just after completion of intervention). Method of measurement: Menstrual Attitude Questionnaire. Patient satisfaction. Timepoint: At the first or second day of the first menstrual cycle just after completion of intervention. Method of measurement: Patient Satisfaction Questionnaire. Disability. Timepoint: At the first or second day of menstrual cycle at two stages (at the cycle prior to the randomization and at the cycle just after completion of intervention). Method of measurement: Sheehan Disability Scale (SDS). Tabriz University of Medical Sciences Approved 2019-04-08 Ethics committee of Tabriz University of Medical Sciences No. 2 Central Building, Tabriz University of Medical Sciences, Golgasht Ave., Tabriz, Iran Tabriz East Azarbaijan Iran (Islamic Republic of)