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IRCT20220629055321N1 IRCT 2022-09-14 Shahroud University of Medical Sciences The effect of educational intervention on performing health behaviors before pregnancy of single-child couples: a clinical trial The effect of an educational intervention based on the integration of the theory of planned behavior and the theory of social cognition on performing health behaviors before pregnancy of single-child couples: a clinical trial 2022-09-11 anticipated 140 Complete https://irct.ir/trial/65243 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Allocation of fertile age couples to intervention and control groups will be done randomly with a random sequence generated using the randomization site, in such a way that for random assignment to the number of samples, we will get a code (code A and B) from the randomization site and We put these codes in a separate envelope in the same order as we got them from the site. Then we stack the envelopes in the order of the codes obtained from the aforementioned website. It should be noted that before starting the sampling, we will conduct a lottery to determine which of the A and B codes obtained from the randomization site will be considered as the intervention group and which code will be considered as the control group. During sampling, the first person who agrees to participate in the intervention takes the first envelope, and after opening the envelope, it is determined whether he is part of the control group or the intervention, and in the same way random allocation for all study samples. will be done. It should be noted that the person who creates the random sequence is different from the person who is involved in the registration process or allocation of participants, Blinding description: The participants do not know in which group (intervention and control) they will be placed. N/A Performing the health behaviors before pregnancy. Intervention 1: Intervention group: The intervention will be held in the form of 4 group training sessions (10 couples in each group) and in-person training using lecture, question and answer methods. The first session: the concept of health, physical and mental health, women's health, the importance of women's health, setting up a health plan, self-care, self-care areas, the second session: reproductive health, ovulation, menstrual cycle, reproductive life plan, age and fertility, reproductive period , the effect of age on fertility in men and women, pregnancy problems in old age (over 35 years) and young age (under 18 years old), the third session: having children, the effects and benefits of having children, the target group of having children, the appropriate age gap between children, the best time Having children, single children and its disadvantages, family planning and fertility control and the fourth session: Pre-pregnancy care, importance of pre-pregnancy care, importance of pre-pregnancy health, healthy lifestyle, pre-pregnancy health assessment, how to perform pre-pregnancy care In health centers, the method of physical and mental preparation for pregnancy (mental health, sexual health, oral and dental hygiene, nutrition and medicinal supplements, physical activities, smoking) was designed. The content of the educational intervention was designed based on the needs of couples (resulting from a qualitative study), experts' opinions, and the most up-to-date studies in the field of pre-pregnancy health. Intervention 2: Control group: they will receive routine pre-pregnancy training from health centers. And the researcher will not interfere in their education. Yes - There is a plan to make this available What will be shared: The data can be published after the completion of the thesis When: One year after finishing the thesis To whom: Mashhad and Shahrood University of Medical Sciences - academic researchers Conditions: After analysis, the data will be available to others through publication in scientific research journals. Where to obtain: fatemeh ghaffari sardasht . Email: ghaffarif891@gmail.com How to obtain: Information will be available through printing the article. But if a person wants more information, he can express his request through email. Comments:
public zahra motaghi
Hafte-Tir Square, Shahrood University of Medical Sciences, Faculty of Medicine, Department of Reproductive Health
shahroud Iran (Islamic Republic of) 36147-73943 +98 23 3239 3962 zmotaghi8@gmail.com Shahroud University of Medical Sciences scientific fatemeh ghaffari sardasht
Hafte-tir Square, Shahrood University of Medical Sciences, Faculty of Medicine, Department of Reproductive Health
shahroud Iran (Islamic Republic of) 3614773943 +98 23 3239 3962 ghaffarif891@gmail.com Shahroud University of Medical Sciences Iran (Islamic Republic of) Iranians and residents of Mashhad Age 15 to 50 years for men and women 18 to 45 years with only one child at least 12 months old Having health records in comprehensive health service centers Having at least primary education Declaration of consent to participate in the research 15 years 50 years Both Secondary infertility Relative or absolute prohibition for pregnancy Z34 Encounter for supervision of normal pregnancy Other N/A Intervention group: The intervention will be held in the form of 4 group training sessions (10 couples in each group) and in-person training using lecture, question and answer methods. The first session: the concept of health, physical and mental health, women's health, the importance of women's health, setting up a health plan, self-care, self-care areas, the second session: reproductive health, ovulation, menstrual cycle, reproductive life plan, age and fertility, reproductive period , the effect of age on fertility in men and women, pregnancy problems in old age (over 35 years) and young age (under 18 years old), the third session: having children, the effects and benefits of having children, the target group of having children, the appropriate age gap between children, the best time Having children, single children and its disadvantages, family planning and fertility control and the fourth session: Pre-pregnancy care, importance of pre-pregnancy care, importance of pre-pregnancy health, healthy lifestyle, pre-pregnancy health assessment, how to perform pre-pregnancy care In health centers, the method of physical and mental preparation for pregnancy (mental health, sexual health, oral and dental hygiene, nutrition and medicinal supplements, physical activities, smoking) was designed. The content of the educational intervention was designed based on the needs of couples (resulting from a qualitative study), experts' opinions, and the most up-to-date studies in the field of pre-pregnancy health. Control group: they will receive routine pre-pregnancy training from health centers. And the researcher will not interfere in their education. Knowledge about health care before pregnancy, which is a set of health information to promote health before pregnancy. Timepoint: Before, immediately and one month after the intervention. Method of measurement: A person's knowledge of pre-pregnancy health care is based on answering the questions in the knowledge section. which is given "one point" for correct answer to each question and "zero point" for each wrong answer or I don't know. The tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014. Attitude towards pre-pregnancy health behaviors, which is the degree of desirability or undesirability of pre-pregnancy health behavior from a person's point of view. Timepoint: Before, immediately and one month after the intervention. Method of measurement: The person's attitude is investigated with a questionnaire based on a 7-point Likert scale with a completely correct to completely incorrect spectrum, the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014. The abstract norm about pre-pregnancy health behaviors expresses the understanding of approval or rejection from family, friends or health workers to perform pre-pregnancy care. Timepoint: Before, immediately and one month after the intervention. Method of measurement: The abstract norm in the individual is investigated with a questionnaire based on a 7-point Likert scale with a completely correct to completely incorrect spectrum, the tool usde psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014. Perceived behavioral control regarding pre-pregnancy health behaviors refers to a person's understanding of the difficulty or ease of doing a task. Timepoint: Before, immediately and one month after the intervention. Method of measurement: Perceived behavioral control in a person is investigated with a questionnaire based on a 7-point Likert scale with a completely correct to completely incorrect range, the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014. Behavioral intention regarding pre-pregnancy health behaviors indicates the amount or extent of a person's motivation to perform health behaviors. Timepoint: Before, immediately and one month after the intervention. Method of measurement: Behavioral intention in a person is investigated with a questionnaire based on a 7-point Likert scale with a completely correct to completely incorrect range, the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014. Self-efficacy in performing prenatal health behaviors, which is one's perception or judgment of one's ability to perform a specific action successfully. Timepoint: Before, immediately and one month after the intervention. Method of measurement: The self-efficacy in carrying out the health behavior of the person is investigated with a questionnaire according to a 7-point Likert scale with a completely correct to completely incorrect range, the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014. Expectancy of consequences regarding pre-pregnancy health behaviors, which represents the individual's opinion about the probability of various consequences of the behavior. Timepoint: Before, immediately and one month after the intervention. Method of measurement: The expectation of the outcome in the individual is examined with a questionnaire based on a 7-point likert scale from completely agree to completely disagree.the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014. Facilitating factors regarding the performance of pre-pregnancy health behaviors, which indicate a person's understanding of tools, resources or environmental changes that facilitate the formation of new behavior. Timepoint: Before, immediately and one month after the intervention. Method of measurement: Facilitating factors in the individual are investigated with a questionnaire based on a 7-point Likert scale from completely agree to completely disagree, the tool used psychometric questionnaire for describing and predicting health behavior before pregnancy based on two theories of planned behavior and social cognition theory resulting from the doctoral thesis of Mrs. Roghieh Bayrami in 2014. Performing health behaviors before pregnancy. Timepoint: Before and one month after the intervention. Method of measurement: The health behavior questionnaire is divided into two parts. One section is about performing preconception health behaviors, which are answered as never, rarely, sometimes, often, and always. There are also some questions about pre-pregnancy care that can be answered with yes and no. The instrument used is a psychometric questionnaire to describe and predict health behavior before pregnancy based on the two theories of planned behavior and the theory of social cognition resulting from the doctorate thesis of Mrs. Ruqieh Bayrami in 2014. Shahroud University of Medical Sciences Approved 2019-05-08 Ethics Committee of Shahroud University of Medical Sciences hafte-tir square shahroud Semnan Iran (Islamic Republic of)