The effect of cognitive counseling on the fear of childbirth and depression in pregnant women: a randomized controlled clinical trial

Determining the effect of cognitive counseling on the fear of childbirth and depression of pregnant women

Randomized, double-blind, with parallel group controlled clinical trials on 120 women for randomization from www.random.org through blockchain with quadruple blocks and 1: 1 assignment ratio to counseling and control groups

The study is performed in Kermanshah health centers by selecting and inviting pregnant women. Women who score higher than 66 on the Fear of Childbirth Questionnaire (W-DEQ) and score 12 or lower on the Edinburgh Depression are included in the study. Participants will be assigned to two groups of counseling and control through random blocking. Due to the lack of knowledge of the statistical analyst about the assignment of individuals to groups, lack of knowledge of participants about the nature of control or intervention of groups and differences in interventions, the study will be double-blind. Mothers in both groups will receive routine prenatal care by the health team. At the end of the research and one month after the last intervention session, the questionnaires will be completed again by the samples in both groups.

Pregnant women 18 to 35 years old with a singleton pregnancy and with a gestational age of more than 20 weeks without a history of chronic disease, infertility and high-risk pregnancy

The intervention group will receive counseling with cognitive therapy approach and the control group will receive routine pregnancy care.

The variables of fear of childbirth and depression in pregnancy that will be measured at the end of the intervention and 4 weeks after the last intervention session will be measured using the questionnaire of fear of childbirth and the Edinburgh Depression Scale.

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.

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).

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