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IRCT20210506051202N1 IRCT 2021-08-21 Tarbiat Modares University Saltuogenesis theory on fear of childbirth Design, implementation, and evaluation of educational program based on saltuogenesis theory on fear of childbirth and choice of delivery method among nulliparous women: a sequential-exploratory mixed methods design 2022-09-23 anticipated 76 Complete https://irct.ir/trial/56113 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: For assigning participants to the two groups of intervention and control will be used blocked randomization method with the size of 4 and 6 blocks. To allocate concealment, the type of intervention is written on paper by a person who has no role in sampling and analyzing the data. These sheets of paper are placed inside identical matte envelopes in an appearance that will be numbered in order. Upon arrival at the center, each participant receives an envelope from one of the coordinated health personnel, Blinding description: To allocate concealment, the type of group will be written on a piece of paper by a person who will have no role in sampling and analyzing the data. These sheets are placed inside identical matte envelopes that will be numbered sequentially. Upon arrival at the center, each participant receives an envelope from one of the coordinated health personnel. In this way, each person will be in one of the control or intervention groups without knowing their group. N/A Fear of childbirth. Intervention 1: Educational content is prepared based on the main factors obtained from qualitative and review stages on the fear of childbirth in nulliparous women. Teaching methods include lecturing, group discussion, question and answer and collaborative learning, problem-solving, talking about positive experiences, and brainstorming. Educational tools include books, posters, brochures, photos, videos, educational slides, recollection of memories, problem-solving workshop, formation of virtual groups and membership of participants in social networking groups, the reflection of values, motivations, needs, and desires of participants about pregnancy and childbirth on a piece of paper and discussion, description and sharing participants' personal skills, and drawing participants pictures of their family (for identifying their role and support in the family). If possible, the educational intervention is held in 4 training sessions of at least 30 minutes in 4 groups of 6 people and 2 groups of 7 people, one day a week for each group at the Health Comprehensive Service Centers of Bostanabad city of East Azerbaijan by the researcher in face to face. A reminder text message is sent to participants about the time and place of the meeting before each meeting. All of the training sessions will be completed by the 16th- week gestation. The evaluation of the educational intervention will be done in two phases; immediately and 6 months after the end of the educational intervention. Participants will re-complete the initial assessment tool. After birth, the method of delivery and the reason for choosing are recorded. Intervention 2: Control group: This group will receive routine pregnancy care. Yes - There is a plan to make this available What will be shared: The demographic characteristics of the participants are confidential, but information about other variables will be shared. When: Six months after the publication of the paper To whom: Researchers in scientific and academic institutions, Health Education and Health Promotion Unit of the Ministry of Health and Family Health Unit of the Ministry of Health Conditions: Educational and research use is allowed with the permission of the ethics committee of the Tarbiat Modares University of Tehran. The request should be made through the Vice Chancellor for Research of Medical Universities. Where to obtain: Corresponding author - Dr. Farkhondeh Aminshokravi aminsh_f@modares.ac.ir How to obtain: Up to one week receiving a request via email to the responsible study corresponding author Comments:
public Safieh Kananikandeh
Valiasr Town
Bostanabad Iran (Islamic Republic of) 5497173579 +98 914 158 0645 kanani.safieh@yahoo.com Tarbiat Modares University scientific Safieh Kananikandeh
Valiasr Town
Bostanabad Iran (Islamic Republic of) 5497173579 +98 914 158 0645 kanani.safieh@yahoo.com Tarbiat Modares University Iran (Islamic Republic of) All primiparous pregnant women in the first trimester of pregnancy 18-35 years High school and university No history of self-reported depression or chronic illness Singleton pregnancy Ultrasound confirmation of fetal health No history of miscarriage or stillbirth Lack of contraindications of vaginal delivery to termination of pregnancy Lack of midwifery base and related fields of study Having consent to participate in the study 18 years 35 years Female Preterm delivery due to an emergency Indications for cesarean section History of cesarean section History of infertility Lack of continuous presence of pregnant women in training sessions Failure to complete the questionnaire Lack of access to the participant for any unpredictable reason F40 Phobic anxiety disorders Behavior Behavior Educational content is prepared based on the main factors obtained from qualitative and review stages on the fear of childbirth in nulliparous women. Teaching methods include lecturing, group discussion, question and answer and collaborative learning, problem-solving, talking about positive experiences, and brainstorming. Educational tools include books, posters, brochures, photos, videos, educational slides, recollection of memories, problem-solving workshop, formation of virtual groups and membership of participants in social networking groups, the reflection of values, motivations, needs, and desires of participants about pregnancy and childbirth on a piece of paper and discussion, description and sharing participants' personal skills, and drawing participants pictures of their family (for identifying their role and support in the family). If possible, the educational intervention is held in 4 training sessions of at least 30 minutes in 4 groups of 6 people and 2 groups of 7 people, one day a week for each group at the Health Comprehensive Service Centers of Bostanabad city of East Azerbaijan by the researcher in face to face. A reminder text message is sent to participants about the time and place of the meeting before each meeting. All of the training sessions will be completed by the 16th- week gestation. The evaluation of the educational intervention will be done in two phases; immediately and 6 months after the end of the educational intervention. Participants will re-complete the initial assessment tool. After birth, the method of delivery and the reason for choosing are recorded. Control group: This group will receive routine pregnancy care. Reduce fear of childbirth. Timepoint: Before the intervention, immediately after the intervention and 6 months after the intervention. Method of measurement: Wijma Delivery Expectancy/Experience Questionnaire- A. Choice of natural childbirth. Timepoint: Before the intervention, immediately after the intervention and 6 months after the intervention. Method of measurement: Checklist for choosing the delivery method. Sense of coherence. Timepoint: Before the intervention, immediately after the intervention and 6 months after the intervention. Method of measurement: Antonovsky Coherence Scale (SOC-13). Tarbiat Modares University Approved 2021-06-26 Research Ethics Committees of Tarbiat Modares University Jalal AleAhmad Ave Tehran Tehran Iran (Islamic Republic of)