In this step a randomized controlled clinical trial will be design to assess the efficacy of the prepared protocol. Participants will randomly be allocated into two groups. In the experimental group we will implement our designed protocol, and the control group will not receive any intervention, but they are evaluated as the same as the experimental group. For ethical issues all educational material will offer at the end of the study (Fig. 1).
Study sample
This interventional randomized study will be conducted on mothers of infants who have been receiving maternity care at health centers in Yazd, Iran. According to the study of Araban et al. [24] and considering the level of significance (α = 0.05) and test power (β = 0.8) as well as the standard deviation of breastfeeding self-efficacy score which is 4.22 and 4.88 in case and control groups respectively, and in order to achieve a significant difference of at least 2.5 points in the mean score of breastfeeding self-efficacy in the intervention and control groups, and taking into account 10% of probable drop, the sample size is considered to be 57 subjects in each group using the following formula.
$$n = \frac{{\left( {Z_{{1 - \frac{\alpha }{2}}} + Z_{1 - \beta } \left( {\sigma_{1}^{2} + \sigma_{2}^{2} } \right)} \right)}}{{d^{2} }}$$
Sampling method
A random sampling method will apply to select the participants. The sampling method will be random and the participants will be in two groups’ intervention and control. The selection of participants to enter the study will be based on a table of random numbers, and to randomize the number of people in the control and intervention groups, cards will be prepared and placed in an envelope, then the participant will be asked to choose a card and based on the lottery will be placed in the control or intervention group.
Inclusion criteria
Inclusion criteria include willingness to participate in the study, primiparous mothers, having an under one-year-old infant, physical health of the child and absence of chronic diseases and chromosomal-genetic defects, no underlying disease, access to mobile phones for connecting to virtual space, ability to use internet and media literacy. Iranian nationality, consent to participate in the study, ability to understand questions or literacy for reading and writing, and not participating in any other clinical trials at the same time.
Exclusion criteria
The diagnosis of chronic illness of the baby, the death of the baby, and the unwillingness of the mother to continue cooperation are the exclusion criteria.
Data collection method
Quality of life questionnaire
The SF-36 Quality of Life Questionnaire is a general questionnaire for assessing the quality of life of individuals; it assesses the quality of life of individuals in 8 domains of physical function, limitations caused by physical problems, social functioning, physical pain, and mental health, limitations caused by mental problems, vitality and general health. The score of each domain is calculated independently and ranges from zero (the worst condition) to 100 (the best condition). Questions of the mentioned dimensions are as follows: physical function (questions 3 to 12); limitation caused by physical problems (13 to 16); social functioning (2, 20 and 32), physical pain (21 and 22), mental health (24 to 28 and 30); limitations caused by mental health problems (17 to 19), vitality (23, 27, 29, 31) and general health (1, 33 to 36). The reliability of this questionnaire has been calculated to be 0.89 and 0.92 by retest and Cronbach's alpha respectively [14].
Breastfeeding self-efficacy scale
The breastfeeding self-efficacy scale is derived from the short form of BSES-SF Dennis. This 14-item scale is designed based on a 5-point Likert scale; so that, I am not sure at all is given score 1, and scores 2 to 5 are given to a bit sure, relatively sure, I am sure, and I am quite sure, respectively. Generally, the range of scores is 14–70, where scores of 14–32 indicate a low level of self-efficacy, 33–51 moderate self-efficacy, and 52–70 high self-efficacy. This scale has been evaluated psychometrically in the study of Araban et al. and its content and form validities have been confirmed; Cronbach's alpha has also been evaluated to be optimal (0.91) [24].
Evaluation of the infants' anthropometric indices
The infant's anthropometric indices will be measured using the ratios of infant weight, height, and head circumference recorded on the infant's health card or health record in the pre-test and post-test stages.
Data analysis
To describe the state of the data, statistics such as the mean and standard deviation of the main research variables (growth rates of infants, breastfeeding self-efficacy, and quality of life) will be determined, and finally, by using SPSS version 22 the mean score of the main variables of the research before and after the intervention will be compared (if the data are normal) with paired t-test and (if the data are not normal) with the non-parametric Wilcoxon test. The randomized trial, will be the statistical analysis "per protocol". 95% confidence interval and P-value < 0.05 will be considered to investigate the effect of the intervention on the mean of the main research variables.
Outcome measures
Breastfeeding self efficacy of mothers
The mean score of Breastfeeding Self efficacy of mothers will be measured using a questionnaire BSES-SF Dennis in the pre-test and post-test phases.
Quality of life of mothers
The mean score of the Quality of Life of mothers will be measured using a questionnaire SF36 in the pre-test and post-test phases.
Infants’ growth status
Infant's anthropometric indices (weight-for-age evaluation, height-for-age evaluation, assess weight for height, and assess head circumference for age and body mass index (BMI) for age( will be measured using the ratios of infant weight, height, and head circumference recorded on the infant's health card or health record in the pre-test and post-test stages.
Ethical considerations
Ethical approval for this study has been obtained by the ethics committee affiliated with Shahid Sadoughi University of Medical Sciences, Yazd, Iran (23/8/2021) reference number IR.SSU.SPH.REC.1400.096), in compliance with the Helsinki Declaration. Ethical considerations include explaining the research objectives to the participants, optional participation in this project, completing the informed consent form by the participants and confidentiality of all information related to the individual and institutional of the study in reporting participation.