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IRCT20201009048974N1 IRCT 2021-01-25 Shahid Beheshti University of Medical Sciences The Comparison of the Effectiveness of Mindfulness-Based Childbirth and Parenting Program and Cognitive-Behavioral Therapy on Pregnancy Anxiety, Birth Satisfaction, Fear of normal delivery, and Labor Pain in Primiparous Women The Comparison of the Effectiveness of Mindfulness-Based Childbirth and Parenting Program and Cognitive-Behavioral Therapy on Pregnancy Anxiety, Birth Satisfaction, Fear of normal delivery, and Labor Pain in Primiparous Women 2020-10-26 anticipated 45 Complete https://irct.ir/trial/51625 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After entering the questionnaire, the participants completed the demographic information questionnaire and after obtaining written consent from both the pregnant woman and her husband and in the absence of her father, randomly divided into two experimental groups (cognitive behavioral therapy and delivery and parenting program based on Mindfulness) and control are assigned. The allocation randomization is simple and uses a random number table. Random allocation concealment will also be done using the central randomization method. After assigning individuals to the groups, a pretest is performed for the variables of labor pain, pregnancy anxiety and fear of normal delivery for individuals in both groups. Then, mindfulness and cognitive-behavioral delivery and parenting programs are implemented for the experimental group. N/A Pregnancy Anxiety, Birth Satisfaction, Fear of normal delivery, and Labor Pain. Intervention 1: Intervention group: Cognitive-behavioral therapy group. Cognitive-behavioral educational intervention in this study was based on appropriate cognitive-behavioral methods to reduce anxiety in pregnant women and programs set by the Ministry of Health during 12 sessions of 90 minutes and twice a week. It should be noted that each intervention session is organized by providing assignments and giving feedback to sample members and performing appropriate exercises, as well as a review of previous sessions. Intervention 2: Intervention group: Mindfulness-based childbirth and parenting program. Participants begin MBCP in the late second or early third trimester and are asked to listen to meditation guide CDs at home 30 minutes a day, 6 days a week. Formal mindfulness meditation instructions include sitting meditation, body monitoring, mindfulness pug, and couple meditation in sessions. These techniques are adapted to cover the mental and physical aspects of pregnancy. Intervention 3: Control group: General education of pregnancy and childbirth. 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 There is no more information
public Maryam Bakhtiari
Velenjak St. , Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1111111111 +98 21 2243 9982 maryam_bakhtiyari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Maryam Bakhtiari
Velenjak St. , Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1111111111 +98 21 2243 9982 maryam_bakhtiyari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) pregnant Women Primiparous Women 18 years 49 years Female psychosis Hi risk pregnancy Taking psychiatric medication Treatment - Other Treatment - Other Prevention Intervention group: Cognitive-behavioral therapy group. Cognitive-behavioral educational intervention in this study was based on appropriate cognitive-behavioral methods to reduce anxiety in pregnant women and programs set by the Ministry of Health during 12 sessions of 90 minutes and twice a week. It should be noted that each intervention session is organized by providing assignments and giving feedback to sample members and performing appropriate exercises, as well as a review of previous sessions. Intervention group: Mindfulness-based childbirth and parenting program. Participants begin MBCP in the late second or early third trimester and are asked to listen to meditation guide CDs at home 30 minutes a day, 6 days a week. Formal mindfulness meditation instructions include sitting meditation, body monitoring, mindfulness pug, and couple meditation in sessions. These techniques are adapted to cover the mental and physical aspects of pregnancy. Control group: General education of pregnancy and childbirth Pregnancy Anxiety Score in PRAQ Questionnaire. Timepoint: Before intervention and after intervention. Method of measurement: PRAQ Questionnaire. Fear score of natural childbirth in Vijma childbirth expectation questionnaire. Timepoint: Before intervention and after intervention. Method of measurement: Vijma childbirth expectation questionnaire. Mindfulness score in the Five Facet Mindfulness Questionnaire and Multidimensional Assessment of Interoceptive Awareness questionnaire. Timepoint: Before intervention and after intervention. Method of measurement: Five Facet Mindfulness Questionnaire and Multidimensional Assessment of Interoceptive Awareness questionnaire. Visual analog scale of labor pain. Timepoint: during labor. Method of measurement: Score zero to 10 on the visual analog scale. Shahid Beheshti University of Medical Sciences Approved 2019-09-24 Research Ethics Committee of School of Medicine - Shahid Beheshti University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)