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IRCT20250106064287N1 IRCT 2025-01-08 Ahvaz University of Medical Sciences Concerns during pregnancy of Nulliparous Adolescent The Effect of Cognitive-Behavioral Therapy Based on Mindfulness on Concerns of Nulliparous Adolescent Pregnant Women 2025-01-20 anticipated 66 Complete https://irct.ir/trial/81161 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible people will be selected for the study by available sampling method and then the participants will be divided into intervention and control groups using simple randomization method. The randomization method used in this study is the use of a table of random numbers. The table of random numbers is a collection of numbers that are generated without a specific pattern or order and completely randomly, and turned into a table. At first, the direction of reading numbers from the table was determined. The direction of reading numbers from the table of random numbers in this study. is from the left side, then the even numbers extracted from the table were assigned to the intervention group and the odd numbers extracted from the table were assigned to the control group. Each group consists of 33 participants.In this study, due to the nature of the interventions, it is practically not possible for the participants and the researcher to be blinded due to the knowledge of the participants about being in the intervention group and the training of the content of the sessions by the researcher, but the concealment of the random allocation by a central method and by another person will take place This ensures that there will be no bias in the selection of intervention and control groups and that the effects of the intervention will be evaluated accurately and fairly. Blinding (according to the researcher) Not blinded. N/A Concerns during pregnancy. Intervention 1: Intervention group: For the intervention group, 8 cognitive-behavioral counseling sessions based on mindfulness will be held during 8 90-minute sessions. In order to evaluate the results of the treatment, relevant questionnaires will be completed by the participants before the intervention, immediately after the intervention, and 4 weeks after the intervention. and will be used for statistical analysis. Intervention 2: Control group: Control group: will receive usual care. In order to evaluate the treatment results, relevant questionnaires will be completed by the participants before the intervention, immediately after the intervention and 4 weeks after 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: Mrs. Mitra Tedin Najafabadi, a member of the academic faculty of Jundishapur University of Ahvaz mitratadayon2000@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 study Comments:
public Mitra Tadayon Najafabadi
Golestan St
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 1373 8071 mitratadayon2000@yahoo.com Ahvaz University of Medical Sciences scientific Mitra Tadayon Najafabadi
Golestan St
Ahvaz Iran (Islamic Republic of) 61357-15794 +98 61 1373 8071 mitratadayon2000@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) marriage Adolescent 10 to 19 years old first pregnancy Gestational age of 20 weeks and above Reading and writing literacy High score based on pregnancy concerns questionnaire 10 years 19 years Female Existence of severe physical problems Having a history of mental illness confirmed by a psychiatrist in yourself or your spouse Participation in other psychological training and counseling programs Existence of high-risk conditions (diabetes mellitus and high blood pressure, etc.) R45.82 Worries Treatment - Other Treatment - Other Intervention group: For the intervention group, 8 cognitive-behavioral counseling sessions based on mindfulness will be held during 8 90-minute sessions. In order to evaluate the results of the treatment, relevant questionnaires will be completed by the participants before the intervention, immediately after the intervention, and 4 weeks after the intervention. and will be used for statistical analysis Control group: Control group: will receive usual care. In order to evaluate the treatment results, relevant questionnaires will be completed by the participants before the intervention, immediately after the intervention and 4 weeks after the intervention and will be used for statistical analysis Concerns during pregnancy. 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: Prenatal Distress Questionnaire. Ahvaz University of Medical Sciences Approved 2024-12-21 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Golestan Blvd., Esfand St., Jundishapur University of Medical Sciences, Ahvaz ahvaz Khouzestan Iran (Islamic Republic of)