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IRCT20230130057274N2 IRCT 2023-12-31 Babol University of Medical Sciences Effectiveness of stress inoculation training approach on premenstrual syndrome Effectiveness of stress inoculation training (SIT) counseling approach on anxiety, and depression of students with premenstrual syndrome 2022-10-30 anticipated 100 Complete https://irct.ir/trial/74663 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Subjects are randomly divided into two groups after applying the inclusion and exclusion criteria in the form of random allocation using the alternative block method. The size of the blocks is 4 and using the statistical software, 4 blocks will be produced 25 times. Considering that the sampling is done in one center, a sample list of 100 items will be produced. Using this randomly generated list, the participants are assigned to two groups of 50 people. The random sequence of people in the intervention or control groups is done through block building with a ratio of 1:1, and the researcher cannot predict the placement of the next person in any of the two groups. N/A Anxiety and depression. Intervention 1: Intervention group: In the intervention group, SIT therapy method is performed individually, which includes 6 consecutive sessions (one session per week) and the duration of each session is 30-45 minutes. The content of the meetings includes:The first session: Conceptualization of the therapeutic model, gaining awareness about the relationship between premenstrual syndrome and negative emotions, acquiring the skills to identify and evaluate thoughts and feelings, relaxation techniquesThe second session: acquiring the ability to identify negative automatic thoughts and begin to change them, relaxation techniquesThe third session: acquiring the ability to recognize cognitive errors, relaxation techniquesThe fourth session: acquiring the skill of correcting auto-negative thoughts, calming techniques The fifth session: acquiring the ability to evaluate daily activities, stress coping techniques, relaxation techniquesThe sixth session: developing effective coping plans for stress, challenges of ending treatment, complete relaxation techniques. Intervention 2: Control group: This group of students does not receive SIT treatment. 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 Confidentiality
public Hajar Adib-Rad
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 0597 Adibrad2015@yahoo.com Babol University of Medical Sciences scientific Hajar Adib-Rad
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 0597 Adibrad2015@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Being Iranian Students living in the student dormitory of Babol University of Medical Sciences Declaration of consent to participate in the study Having premenstrual syndrome Having regular menstrual cycles with intervals of 21 to 35 days and a duration of 3 to 7 days at least during the last six months Having 5 symptoms of premenstrual syndrome for two consecutive months Having symptoms of depression or anxiety with a score of 8 or higher Access to the smartphone Age range from 18 to 38 years 18 years 38 years Female Use of antidepressants and anxiety medications during the study Participation in other psychological interventions such as psychotherapy, meditation, yoga Occurrence of stressful events at least six months before the start of the study Suffering from genital diseases and known and chronic underlying diseases Taking birth control pills Hormonal disorders and irregular menstruation Current or history of severe mental illness such as severe depression, bipolar disorder, and suicidal thoughts Drug addiction and consumption of psychoactive substances or alcohol F41.2 Mixed anxiety and depressive disorder Treatment - Other Treatment - Other Intervention group: In the intervention group, SIT therapy method is performed individually, which includes 6 consecutive sessions (one session per week) and the duration of each session is 30-45 minutes. The content of the meetings includes:The first session: Conceptualization of the therapeutic model, gaining awareness about the relationship between premenstrual syndrome and negative emotions, acquiring the skills to identify and evaluate thoughts and feelings, relaxation techniquesThe second session: acquiring the ability to identify negative automatic thoughts and begin to change them, relaxation techniquesThe third session: acquiring the ability to recognize cognitive errors, relaxation techniquesThe fourth session: acquiring the skill of correcting auto-negative thoughts, calming techniques The fifth session: acquiring the ability to evaluate daily activities, stress coping techniques, relaxation techniquesThe sixth session: developing effective coping plans for stress, challenges of ending treatment, complete relaxation techniques Control group: This group of students does not receive SIT treatment. Anxiety. Timepoint: Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention. Method of measurement: Hospital anxiety and depression questionnaire. Depression. Timepoint: Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention. Method of measurement: Hospital anxiety and depression questionnaire. Stress. Timepoint: Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention. Method of measurement: Perceived Stress Questionnaire 14. Performance. Timepoint: Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention. Method of measurement: Sheehan's Disability Questionnaire. Psychological well-being. Timepoint: Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention. Method of measurement: Riff's Psychological Well-Being Questionnaire. Symptoms of premenstrual syndrome. Timepoint: Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention. Method of measurement: Premenstrual Symptoms Screening Questionnaire. Babol University of Medical Sciences Approved 2022-10-30 Health Research Institute - Babol University of Medical Sciences (Research Ethics Committee) Ganj Afrooz St., Babol University of Medical Sciences Babol Mazandaran Iran (Islamic Republic of)