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IRCT20170116031977N2 IRCT 2022-02-23 Kermanshah University of Medical Sciences The effect of cognitive counseling on fear of childbirth and depression in pregnant women The effect of cognitive counseling on the fear of childbirth and depression in pregnant women: a randomized controlled clinical trial 2022-04-04 anticipated 120 Complete https://irct.ir/trial/61865 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to execute random allocation, random sequencing will be created by the method of "random allocation law". This method consists of a large block for the entire sample size, so that the balance in the number of people assigned to each group is achieved at the end of the study. After determining the sample size by the researcher, in the first stage, the specified number will be selected from the people who meet the inclusion criteria and have signed the informed consent form, if desired. Pregnant women who complete the pre-test questionnaires will be randomly assigned to two groups (60 in the counseling intervention group and 60 in the control group) using a computer-generated random number table at random.org. To conceal the allocation, the type of intervention was written on paper and placed inside opaque and numbered envelopes. The envelopes will be opened in order of entry and pregnant women will be in the intervention or control group, Blinding description: Due to the lack of a person allocating ethnic resources, the lack of knowledge of the statistical analyst about the allocation of individuals to the groups, the lack of knowledge of the participants about the nature of control or intervention of groups A and B and the difference between trainings / interventions will be a double-blind study. Due to the nature of psychological interventions, it is not possible to blind learners. Questionnaires will be completed before assigning participants to intervention and control groups, using sealed envelopes (blinding participants) and presenting the intervention at a time other than the presentation of routine programs and submitting a questionnaire to the intervention group on a non-day From the day of submission to the control group. After the intervention, the people collecting the questionnaires and entering the information were not aware of the group of people and the data analyst would not be from the group of people providing the intervention (information blinding and analysis). N/A Condition 1: Fear of childbirth. Condition 2: Depression in pregnancy. Intervention 1: Intervention group: For the intervention group, counseling in the form of groups of 10 people with a cognitive approach is performed in 6 sessions of 90-60 minutes in one of the health centers of Kermanshah that has suitable conditions. Intervention 2: Control group: The control group will receive routine prenatal care and, in addition, a training session will be held after the end of the second phase of the assessment. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Azam Bakhteh
School of Midwifery Nursing, Haft Tir Square, Shahroud
Shahroud Iran (Islamic Republic of) 3614773955 +98 23 3239 1609 aa_bakhteh@kums.ac.ir Shahroud University of Medical Sciences scientific Zahra Motaghi
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud
Sharoud Iran (Islamic Republic of) 3614773955 +98 23 3239 1609 zhrmotaghi@yahoo.com Shahroud University of Medical Sciences Iran (Islamic Republic of) All pregnant women who have a singleton pregnancy Pregnant women over 20 weeks of gestation Pregnant women should be literate (at least elementary) Pregnant women who have the ability to call and follow up Pregnant women with a Vijama score above 66 18 years 35 years Female Pregnant women with chronic diseases (such as diabetes, etc.) Pregnant women with a history of infertility Pregnant women with high-risk pregnancies Pregnant women with psychiatric disorders Pregnant women taking certain medications F40.9 F53.0 Phobic anxiety disorder, unspecified Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified Behavior N/A Intervention group: For the intervention group, counseling in the form of groups of 10 people with a cognitive approach is performed in 6 sessions of 90-60 minutes in one of the health centers of Kermanshah that has suitable conditions. Control group: The control group will receive routine prenatal care and, in addition, a training session will be held after the end of the second phase of the assessment. Fear of childbirth. Timepoint: Before the intervention, after the intervention and 1 month after the last intervention session. Method of measurement: Wijma Delivery Expectancy Questionnaire (W-DEQ). Depression. Timepoint: Before the intervention, after the intervention and 1 month after the last intervention session. Method of measurement: Edinburgh Postpartum Depression Scale. Childbirth Satisfaction. Timepoint: 1-3 days after delivery. Method of measurement: Mackey Childbirth Satisfaction Rating Scale. Delivery method. Timepoint: After childbirth. Method of measurement: medical documents. Kermanshah University of Medical Sciences Approved 2020-12-23 Ethics Committee of Shahroud University of Medical Sciences Seventh Tir Square, Shahroud University of Medical Sciences and Health Services, Vice Chancellor for Research and Technology Shahroud Semnan Iran (Islamic Republic of)