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IRCT20170611034452N17 IRCT 2023-12-11 Kerman University of Medical Sciences Investigating the effectivemess of psychological intervention on some health factors of pregnant women Investigating the effectiveness of psychological intervention in the first semester on some health parameters at the end of the second trimester 2024-01-21 anticipated 60 Complete https://irct.ir/trial/73834 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this intervention, 60 pregnant women who meet the inclusion criteria for entering the study from among the referrals to two gynecologists of private centers in Kerman in the time period until the sample size is reached (available sampling) with the limited randomization method according to the law of random allocation in two similar group (each group of 30 people) is placed in intervention and control. For this purpose, using random allocation software, a random sequence is generated based on two intervention and control groups, then based on this generated sequence, people are allocated to two intervention and control groups. N/A Psychological intervention in primigravida pregnant women without underlying disease. Intervention 1: Intervention group: 30 pregnant women who meet the inclusion criteria in the first trimester receive three sessions of psychological intervention, each session lasting 60-90 minutes and one session per week. Intervention 2: Control group: 30 pregnant women who are in the control group do not receive any psychological intervention. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: with previous agreement with the corresponding author Where to obtain: email address How to obtain: email address Comments:
public Atefeh Ahmadi
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5220 a.ahmadi@kmu.ac.ir Kerman University of Medical Sciences scientific Atefeh Ahmadi
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5220 a.ahmadi@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) primigravida pregnant women up to 9 weeks gestational age age 18-45 years singleton pregnancy non-participation in other psychotherapy sessions unwanted pregnancy fluency in persian language absence of any underlying and chronic diseases non-use of sedatives non-infection of Other psychological diseases before starting the intervention 18 years 45 years Female Loss of pregnancy during the intervention occurrence of a traumatizing event such as the loss of loved ones absence from a session of the intervention O09.31 Supervision of pregnancy with insufficient antenatal care, first trimester Behavior Behavior Intervention group: 30 pregnant women who meet the inclusion criteria in the first trimester receive three sessions of psychological intervention, each session lasting 60-90 minutes and one session per week. Control group: 30 pregnant women who are in the control group do not receive any psychological intervention. Anxiety state of people. Timepoint: Before the intervention in the first trimester of pregnancy and the second trimester of pregnancy. Method of measurement: Pregnancy-related anxiety questionnaire and Penn State worry questionnaire. Sleep quality. Timepoint: Before the intervention in the first trimester of pregnancy and the second trimester of pregnancy. Method of measurement: PSQI sleep quality questionnaire. Blood pressure. Timepoint: Before the intervention in the first trimester of pregnancy and the second trimester of pregnancy. Method of measurement: Sphygmomanometer. FBS. Timepoint: Before the intervention in the first trimester of pregnancy and the second trimester of pregnancy. Method of measurement: Blood samples from people and in the laboratory. Thyroid disorders. Timepoint: Before the intervention in the first trimester of pregnancy and the second trimester of pregnancy. Method of measurement: Blood samples from people and in the laboratory. Kerman University of Medical Sciences Approved 2023-11-04 Research Ethics Committees of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University campus. Haft. Bagh Highway,Kerman ,Iran Kerman Kerman Kerman Iran (Islamic Republic of)