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IRCT20200514047449N1 IRCT 2020-06-28 Islamic Azad University Comparison the Effectiveness of Cognitive Behavioral Therapy and Mindfulness-Based Stress Reduction on Anxiety, Psychological Well-being, Marital Satisfaction and Maternal Neonatal Outcomes of Nuliparous women Comparison the Effectiveness of Cognitive Behavioral Therapy and Mindfulness-Based Stress Reduction on Anxiety, Psychological Well-being, Marital Satisfaction and Maternal Neonatal Outcomes of Nuliparous women 2019-12-11 anticipated 45 Complete https://irct.ir/trial/49205 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using the block randomization method by the statistical consultant, the following randomization is done in 3 groups of cognitive behavior therapy (CBT), Mindfulness-based stress reduction (MBSR) and control: First, the list of names of qualified people is provided and coded. In block randomization, the number of participants in all groups will be very close, this is done by building blocks of sequences and intersections so that the same number of participants are allocated to study groups within each group. First, we encode the groups based on the Latin letters as follows: A =cognitive behavior therapy, B = Mindfulness-based stress reduction and C control group In this study, with three groups A, B and C, we create the following six groups and assign the numbers 1 to 6 to each: ABC-ACB-BAC-BCA-CAB-CBA Then, using the table of random numbers, we contract that if the numbers 1, 2, 3, 4, 5, 6, and 6 appear in order, one of these blocks will be selected, and if another number appears, we will assume it to be null and void and move on to the next selection. In fact, we have obtained a random sequence of numbers with a table of random numbers, which we consider the order of the assigned allocation for each number. In this way, the number of people in the groups will be almost equal. N/A Pregnancy. Intervention 1: First Intervention Group: MBSR-based stress reduction training was conducted for 8 weekly sessions (120 minutes each session) for the experimental group. The regular routine of each session included reviewing the homework of the previous session, feedback on existing questions and problems, teaching the intended materials and techniques, meditation skills, discussing stress and coping techniques, and presenting homework. Intervention 2: Second Intervention Group: Cognitive Behavioral Therapy refers to the training that is performed once a week for 10 sessions and for 45 minutes each session for mothers. Familiarity with the process of childbirth is marital satisfaction. Intervention 3: Control group: No Intervention. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information about the main outcome or the like, can be shared. When: Start of access period 6 months after printing results To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: Any type of analysis on the data delivered is permitted Where to obtain: Elahe Shahtaheri Adress: No. 11, West Azerbaijan Ave., Valiasr Blvd. Tel: +98 21 8457 9643 How to obtain: The request will be sent by email to: elishah1348@gmail.com Comments:
public Elahe Shahtaheri
Nombr 26, #4 Alley Ali hosseini ST, Niazzadeh ST, Zaferanieh AVE, valieasr, Tehran
Tehran Iran (Islamic Republic of) 2578695784 +98 21 2243 5703 e.shahtaheri@iaukishint.ac.ir Islamic Azad University scientific Elahe Shahtaheri
Nombr 26, #4 Alley, Ali hosseini ST, Niazzadeh ST, Zaferanieh AVE, valieasr, Tehran
Tehran Iran (Islamic Republic of) 2578695784 +98 21 2243 5703 e.shahtaheri@iaukishint.ac.ir Islamic Azad University Iran (Islamic Republic of) Being Iranian Age range 20 to 35 years Being primitive Have literacy No history of miscarriage or intrauterine death and infertility Absence of pregnancy problems (blood pressure, bleeding, diabetes, thyroid disease, placenta previa, fetal anomalies) No accidents during the last 6 months Not addicted and not being treated for psychiatric disorders 20 years 35 years Female No cooperation of the sample group at each stage of the study Having physical and physical problems and a history of psychiatric problems Treatment - Other Treatment - Other N/A First Intervention Group: MBSR-based stress reduction training was conducted for 8 weekly sessions (120 minutes each session) for the experimental group. The regular routine of each session included reviewing the homework of the previous session, feedback on existing questions and problems, teaching the intended materials and techniques, meditation skills, discussing stress and coping techniques, and presenting homework. Second Intervention Group: Cognitive Behavioral Therapy refers to the training that is performed once a week for 10 sessions and for 45 minutes each session for mothers. Familiarity with the process of childbirth is marital satisfaction. Control group: No Intervention Anxiety. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Beck Anxiety Inventory. Psychological well-being. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Psychological well-being Questionnaire. Marital satisfaction. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Marital satisfaction Questionnaire. Infant Maternal Consequences. Timepoint: Measurement will be done in pre-test, post-test and follow-up three months after post-test. Method of measurement: Checklist of Infant Maternal Consequences. Islamic Azad University Approved 2019-12-07 Ethics committee of Hormozgan University of Medical Sciences No. 64, Janbazan Ave., North Karegar Street Kish Hormozgan Iran (Islamic Republic of)