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IRCT20190206042641N1 IRCT 2019-07-03 Shahroud University of Medical Sciences Evaluating effectiveness of Mindfulness-based Counseling on Pregnancy Concerns and Anxiety Evaluating effectiveness of Mindfulness-based Counseling on Pregnancy Concerns and Anxiety 2019-05-29 anticipated 60 Complete https://irct.ir/trial/38838 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Sampling will be done from specific health centers of 3 poor, medium and high socioeconomic regions of Mashhad, Randomization description: Randomization is done by blocking method to balance the number of specimens assigned to each of the studied groups. In this way, the size of the blocks can be constant or variable. In this research, we used blocks with 4 equal numbers. Unit of randomization is individual. Random Block Sequencing Website have been used for randomization. The random sequence of locking is given to a specific person outside the research team and each mother assigns to either intervention or control group according to the time of arrival and random sequence. N/A Condition 1: anxiety in pregnant women. Condition 2: worry in pregnant women. Condition 3: Mindfulness-based counseling. Intervention 1: Intervention group: Pregnant women with high anxiety score, will receive 6 mindfulness-based counseling sessions within 6 consecutive weeks. The number of participation in each groups is 8 to 12 people, and the duration of each session will be about 90 minutes. Each session has an educational purpose and the participation practice Mindfulness exercises during the session. Also, homework is recommended for women to practice Mindfulness in everyday life. Intervention 2: Control group: Pregnant women with high anxiety score, attend Preparation for Labor classes regularly, and no additional intervention will be done for this group.After 6 weeks, intended questionnaires will be completed again by the women. 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 I will decide after sampling.
public Reyhaneh Abbasi
Shahrood University of Medical Sciences, Haft e Tir Square
Shahrood Iran (Islamic Republic of) 7394736147 +98 23 3239 5054 abbasir911@gmail.com Shahroud University of Medical Sciences scientific Reyhaneh Abbasi
Shahrood University of Medical Sciences, Haft e Tir Square
Shahrood Iran (Islamic Republic of) 7394736147 +98 23 3239 5054 abbasir911@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) being Iranian and Persian speaking being satisfactory and interesting in participating in the research being her first pregnancy being within 12 and 24 weeks of pregnancy being a singleton pregnancy. getting 10 points of 6-item Kessler questionnaire at least 18 years 45 years Female Having high risk pregnancy items Suffering from any chronic illnesses during pregnancy Participate in yoga classes, mindfulness and mind management in the last 6 months Use of psychiatric drugs in a recent year Use Drug and psychotropic substances Having a history of psychiatric illness F06.4 R45.82 Anxiety disorder due to known physiological condition Worries Behavior N/A Intervention group: Pregnant women with high anxiety score, will receive 6 mindfulness-based counseling sessions within 6 consecutive weeks. The number of participation in each groups is 8 to 12 people, and the duration of each session will be about 90 minutes. Each session has an educational purpose and the participation practice Mindfulness exercises during the session. Also, homework is recommended for women to practice Mindfulness in everyday life. Control group: Pregnant women with high anxiety score, attend Preparation for Labor classes regularly, and no additional intervention will be done for this group.After 6 weeks, intended questionnaires will be completed again by the women. Anxiety Score of Pregnant Women in Wendenberg Pregnancy Anxiety Inventory. Timepoint: Completing Wendenberg Anxiety Inventory before, after and 1 month after intervention. Method of measurement: Pregnancy Related Anxiety Questionnaire (Wendenberg). Pregnant women's worry score by Prenatal Distress Questionnaire. Timepoint: Completing the Prenatal Distress Questionnaire before, after and 1 month after intervention. Method of measurement: Prenatal Distress Questionnaire. Shahroud University of Medical Sciences Approved 2019-05-08 Ethics committee of Shahrood University of Medical Sciences Shahrood University of Medical Sciences, 7th of Tir square Shahrood Semnan Iran (Islamic Republic of)