Study aimsThe main aim

The main objective of this study is to evaluate the effectiveness of an integrated theory-based educational intervention on the intentions of childless couples to have a child.

Secondary aims 1.

Evaluate changes in intentional stages.

2.

Assess the impact of the training program on factors influencing behavior (attitude, subjective norms, perceived behavioral control, and behavioral intention).

3.

To investigate the relationship between demographic characteristics of couples and the intention to have children.

Trial design

This study is a parallel group clinical trial. The TTM and TPB are used for training and measuring outcomes. The participants are childless couples who have been married for at least 2 years and are in the pre-contemplation and contemplation stages of having children. A diagram of the research process is shown in Fig. 1. After the intervention, their attitudes, subjective norms, and perceived level of control over childbearing behavior will be compared with before the intervention, to determine whether the interventions lead couples out of the pre-contemplation stage to later stages or not. The duration of this study is approximately 2 years from the beginning of the training to the end of the follow-up (6 months after the intervention). This study was approved by the Ethics Committee (Ethics Code: IR.TUMS.FNM.REC.1402.013) of Tehran Medical University. Informed consent is completed by all participants after an explanation of the objectives of the study, the research process, and the follow-up period.

Fig. 1Setting and participants

The intervention will take place in Tehran, the capital of Iran. Samples from the control and intervention groups will be selected from the Primary Health Center (PHC). Participants will be 30 couples who have been married for at least 2 years or more and have not been diagnosed with infertility. The couple's infertility will be determined based on their previous medical records available at medical centers.

Inclusion criteria

Aged from 18 to 40 years old for women and up to 45 years old for men, want to participate in research, being in the pre-contemplation or contemplation stage, married for 2 years or more, no contraindications to pregnancy, have no history of infertility, use of contraceptives, have no mental disability that interferes with learning.

Exclusion criteria

Unwillingness to participate in the study, not attending more than one session, diagnosed infertility, or any chronic disease contraindicated for pregnancy.

Interventions

After receiving the ethical code from the Research Center of Tehran University of Medical Sciences, the study will begin. The educational content of this study will be prepared under the supervision of specialized professors of the university and the researcher will acquire the necessary knowledge and skills to carry out the educational program under the supervision of professors. In preparing this content, we will try to include the following: Complications due to reduced population growth, factors affecting the reduced ability to have children, effects of reduced population growth on family and society, complications of pregnancy at older ages, effects of father's age, benefits of having children, economic effects of demographic decline. The choice of the content is based on: the educational needs of the couples reflected in the studies, the cultural problems of the society, and the subjects mentioned by the Ministry of Health of Iran. After the teaching materials are prepared, their contents are scientifically evaluated by the Tehran University of Medicine professors, and after their approval, the intervention and training process will begin. Teaching classes will be conducted in 4 sessions and each session will last at least 60 min with the presence of couples (Table 1).

Table 1 The content of the educational sessions based on the theory of planned behavior

Participants who meet the inclusion criteria will first complete a childbearing intentions questionnaire, which will be designed based on the stages of the change model and the samples who are in the pre-contemplation and contemplation stage will be included in the study. After this step, by accessing the Sib system “a national system that records health information of individuals”, couples who have been married for 2 years without children and meet the inclusion criteria will be selected. Then, 60 samples (30 pairs) will be selected through a random number table and will be randomly divided into 2 groups: control and intervention.

Teaching methods will include conferences, discussions, Q&A, and document distribution. During the classes, the researcher does not impose personal views and attitudes on the couple. It is explained to them that all decisions about having children are based entirely on their opinions and considerations and there is no coercion. They must also fill in the questionnaires without concern and honesty because their answers do not affect the quantity and quality of the treatment, and whenever they do not want to participate in the study, they can refuse to continue.

OutcomesPrimary outcome

As mentioned, the most important thing in a couple's decision to have children is the intention to do so and a positive attitude towards it, so:

Change the behavior of couples to the operation and maintenance phase according to the TTM after the procedure

Change to a positive attitude toward having a baby.

Secondary outcomes

Increase awareness among couples about complications related to delaying childbirth

Increases the couple's sense of reproductive control

Improve the capacity of couples to cope with the spiritual standards of society

Increase couples' preparedness to make informed fertility decisions.

Data collection

A questionnaire designed by researchers will be used to assess the impact of this intervention on people's attitudes and subjective norms. This questionnaire is administered to assess the three components of attitude, subjective norms, and perceived behavioral control and to determine how the change process is carried out in four stages: before the intervention (S0), immediately after the intervention (S1), 1 month after the intervention (S2) and 6 months after the procedure (S3).

The questions prepared for this study will be designed based on: Research objectives, two mentioned models, and teaching content. Once designed by the researcher, it will be sent to specialist teachers and their validity and reliability will be assessed. Questions in the S0 phase are filled in person at the clinic, but to allow people to better receive questions and answers without the need to visit the clinic, the questions asked in the questionnaire will be sent online in the later stages. This Iranian online system is called Porsline, and at an agreed time, a link to the survey is sent to participants, and the researcher monitors their responses by phone.

The study instruments1Demographic information questionnaire

This questionnaire will include the couple's demographic information: age, education level, occupation, income, age at marriage, and duration of marriage. Additionally, information about a woman's fertility will include abortion, age at first menstruation, menstrual cycle regularity, and possible prevention methods. This questionnaire will only be completed in person at the beginning of the study.

Level of knowledge

The questions in this section are based on the material taught in the training sessions and are designed to investigate changes in the level of awareness of participants, as increasing the awareness of couples can help them make better decisions in the field of reproduction [29].

Trans-theoretical model questionnaire (TTM)

At the beginning of the study, to find out whether the person meets the criteria to enter the study or not, the participant must fill out a questionnaire about the stages of change, and whether they are in the pre-contemplation or contemplation stage, it is included in the study. This questionnaire is designed based on the stages of the change model and includes 7 questions to determine which stage the person is in. After the intervention, each participant's level of change toward the next steps in behavioral intentions will be measured using this questionnaire according to specific steps.

Theory of planning behavior questionnaire (TPB)

The next questionnaire developed by the researchers will be based on the theory of planned behavior. According to this theory, human behavior is directly determined by three main factors: attitudes, subjective norms, and perceived behavioral control [27]. Therefore, the designed questionnaire will also have three parts. 15 questions will measure individual attitudes, 10 questions will measure subjective norms and 25 questions will measure perceived behavioral control of the couples. Due to the influence of different environmental factors on the "Perceived behavioral control" factor, questions related to economic issues (6 questions), employment and work-related factors (5 questions), educational factors (2 questions), social factors (6 questions), questions about physical factors (3 questions) and mental factors (3 questions) are designed separately.

Validity and reliability

In this study, three questions need to be tested for validity and reliability:

Knowledge level, TTM, and TPB. The reliability of the questions will be determined by its internal consistency (Cronbach's alpha) and the content validity of the questions will be assessed using both qualitative and quantitative methods. In the qualitative method, 10 experts evaluate the questionnaire, including faculty members of the Department of Midwifery and Reproductive Health of Tehran University of Medical Sciences, and after receiving their opinions, the proposed changes will be applied. The Content Validity Index (CVI) and Content Validity Ratio (CVR) are measured quantitatively. For face validity, we ask 10 couples to give comments on the clarity of the survey, and based on their opinions, basic explanations are given, if the survey is unclear from the couple's point of view, the necessary corrections will be performed.

Sample size

To provide a power of 95% with a 99% confidence interval using the following formula and considering the mean and standard deviation of intention to have based on the findings of a similar study by Moghaddam et al. [36]. The sample size was estimated at 12, and then considering 20% attrition, we plan to recruit 15 couples per group and a total of 30 couples study participants.

$$n=\frac_}+ _ )}^ (_^+ _^)}_- _)}^}=\frac=\frac=11.93 \cong 12$$

Randomization

After checking the participants' basic information regarding the inclusion criteria, a list will be prepared, and then, to randomly divide them into two intervention and control groups, samples will be allocated into two groups based on the Random Number Table. Because interventions aim to educate people, participants cannot be blinded. The people targeted by the intervention are therefore aware of the group to which they belong.

Blinding

Additionally, there was no possibility of blinding the researcher due to the organization of the training sessions and the conduct of the interventions. However, medical center staff will be blinded. Blinding is also done when dividing the participants into two control and intervention groups and during the statistical analysis of the data. Training sessions for the intervention group will take place on days when people in the control group are not present at the clinic so that information is not randomly delivered to them and they do not communicate with each other. This issue will be the reason for the long process (about 2 years) of this research.

Statistical analysis

The analytical method used in this study will be quantitative. The information recorded in the questionnaire will be entered into the SPSS program at each stage and data analysis will be conducted after the research process is completed. Categorical variables will be reported based on frequency, and quantitative variables will be reported as mean (SD). The ANOVA test will be used for quantitative variables that have a normal distribution, and the Friedman test will be used for quantitative variables that do not have a normal distribution. The effectiveness of the intervention will be determined using an ANOVA test and the impact of demographic variables on factors measured using a logistic regression model. Statistical analyses will be performed using IBM-SPSS 22. For all analyses, P values  < 0.05 are considered statistically significant.

Ethics approval and ethical considerations 1.

Receive the Code of Ethics and Letter of Recommendation from the Medical Ethics Council of the Faculty of Nursing and Midwifery (Ethics Code: IR.TUMS.FNM.REC.1402.013).

2.

Get permission to enter the medical center where the study is taking place.

3.

Respect ethical principles when conducting research.

4.

Present the research sample to the researcher and explain the objectives.

5.

Emphasis is placed on voluntary participation and obtaining informed consent.

6.

Ensure confidentiality of information of all participants.

7.

Announce accurate and realistic results.