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IRCT20241126063869N1 IRCT 2024-12-06 Ahvaz University of Medical Sciences Investigating the effect of mindfulness counseling on depression, stress and anxiety of pregnant women with a history of primary infertility Investigating the effect of mindfulness counseling on depression, stress and anxiety of pregnant women with a history of primary infertility 2024-12-21 anticipated 88 Complete https://irct.ir/trial/80533 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible individuals will be selected for the study using convenience sampling, and then participants will be divided into two intervention and control groups using simple randomization. The randomization method used in this study is the use of a random number table. A random number table is a set of numbers that are generated completely randomly without a specific pattern or order and are arranged in the form of a table. Initially, the direction of reading the numbers from the table was determined. The direction of reading the numbers from the random number table in this study is from the left, then even numbers extracted from the table were assigned to the intervention group and odd numbers extracted from the table were assigned to the control group. Each group consists of 44 participants. In this study, due to the nature of the interventions, blinding for the participants and the researcher is practically not possible due to the knowledge of the participants about being in the intervention group and the content of the sessions by the researcher, but the concealment of random allocation will be done centrally and by another person. This ensures that there is no bias in the selection of intervention and control groups and that the effects of the intervention are accurately and fairly assessed. N/A Stress, anxiety, depression. Intervention 1: Intervention group: For the intervention group, 8 mindfulness counseling sessions will be held over 8 sessions of 1.5 to 2 hours. In order to evaluate the results of treatment, the relevant questionnaires will be completed by the participants before the start of the intervention, immediately after the end of the intervention, and 4 weeks after the end of the intervention and will be used for statistical analysis. Intervention 2: Control group: will receive usual care along with educational booklet. In order to evaluate the treatment results, the relevant questionnaires will be completed by the participants before the start of the intervention, immediately after the end of the intervention, and 4 weeks after the end of the intervention and will be used for statistical analysis. Yes - There is a plan to make this available What will be shared: The data of the study are classified and coded so that the names of the people cannot be identified. When: Access to the study data is possible after the results are published in the journal. To whom: All people who want to use the data in this field can access the study data. Conditions: Study data can be used for comparison with other results. Where to obtain: Dr.Zahra Abbaspoor Abbaspoor_z762@yahoo.com How to obtain: The request is sent by e-mail to the person in charge of the scientific or general responsibility of the studyAbbaspoor_z762@yahoo.com Comments:
public Zahra Abbaspour
Golestan St
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8395 Abbaspoorzahra7@gmail.com Ahvaz University of Medical Sciences scientific Zahra Abbaspour
Golestan St
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 3373 8395 Abbaspoorzahra7@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Informed consent to participate in the study Being literate Age between 20-40 years History of primary infertility Gestational age 14-20 weeks according to LMP or first trimester ultrasound Mild to moderate stress, anxiety, and depression according to the DASS-21 questionnaire. Pregnancy was achieved through assisted reproductive techniques. 20 years 40 years Female Fetal abnormality History of mental illness according to the individual's report Chronic physical illness Experience of adverse events in the past three months Previous receipt of psychological counseling services outside of treatment sessions F41.2 Mixed anxiety and depressive disorder Treatment - Other Treatment - Other Intervention group: For the intervention group, 8 mindfulness counseling sessions will be held over 8 sessions of 1.5 to 2 hours. In order to evaluate the results of treatment, the relevant questionnaires will be completed by the participants before the start of the intervention, immediately after the end of the intervention, and 4 weeks after the end of the intervention and will be used for statistical analysis. Control group: will receive usual care along with educational booklet. In order to evaluate the treatment results, the relevant questionnaires will be completed by the participants before the start of the intervention, immediately after the end of the intervention, and 4 weeks after the end of the intervention and will be used for statistical analysis. Anxiety score in dass 21. Timepoint: Before the start of the intervention, immediately after the end of the intervention sessions, 4 weeks after the end of the intervention. Method of measurement: Dass 21 questionnaire. Depression score on dass 21. Timepoint: Before the start of the intervention, immediately after the end of the intervention sessions, 4 weeks after the end of the intervention. Method of measurement: Dass 21 questionnaire. Stress score in dass 21. Timepoint: Before the start of the intervention, immediately after the end of the intervention sessions, 4 weeks after the end of the intervention. Method of measurement: Dass 21 questionnaire. Ahvaz University of Medical Sciences Approved 2024-11-30 Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences Esfand Ave.,Golestan Blvd,Ahvaz JundiShapour University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)