The effect of mindfulness-based counseling on fear of delivery in primiparous women:Randomized controlled trial

Determining the effect of mindfulness-based counseling on fear of childbirth in primiparous women

In this study, the participants were selected using convenience sampling, and were assigned into the intervention (Chewing gum) and control groups with a ratio of 1:1 by blocked randomization using Random Allocation Software (RAS) with a block size of 4.However, blinding was not possible due to the nature of the treatment modalities in the two groups, so the study used an open-label design.

Sampling will be done in an easy way among people from the research community who meet the entry criteria. The sampling location of public and private sector health centers of Qaemshahr city will be covered by Mazandaran University of Medical Sciences. By using random method with blocks of 4 (ABAB), the study subjects will be divided into two groups, A and B. Due to the intervention methods of the two groups, blinding is not possible and the study is open label and sampling is available.

1 Informed consent of expectant mothers 2. Pregnant women 20 to 28 weeks 3. Pregnant women aged 18 to 42 years 4. No previous history of childbirth 5. Without serious complications in pregnancy (pre-eclampsia, gestational diabetes, disorders Pair) 6. No history of known mental disorders (problems). 7. Absence of pregnancy by medicinal or laboratory method 8. Pregnant mothers equipped with smartphones 9. Absence of unwanted pregnancy 10 points less than 85 from the Wijma questionnaire 11. Participation in childbirth preparation classes

One face-to-face group counseling session based on mindfulness will be sent to the intervention group by the project manager and 7 sessions through social network for 90 minutes once a week.

The fear of childbirth in primiparous women

The method of allocating the samples to the groups will be randomly block in two equal intervention and control groups, in blocks of four. As a result, we will have 18 different blocks (18 quadruple blocks) (72 people in two groups, 36 intervention and control). Randomization is done by generating random numbers and random list using Random Allocation Software. The random sequence of people in the intervention or control groups is done through block building with a ratio of 1:1, and the researcher cannot predict the placement of the next person in any of the two groups. For the random sequence on study participants, from concealment (Allocation Concealment (random allocation) will be used, that is, before assigning a person in a group, that assigned group will not be known. Without allocation concealment of the random sequence, it is possible that the random sequence will be revealed and the randomization process will be weakened. The statistician will prepare the random list with Allocation Random Software and only the supervisor will be aware of the coding of intervention and control groups, the statistician responsible for data analysis is not aware of the coding of the two groups. Send feedback