The Impact of Involvement of Father's with Preterm Newborns on their Paternal-Infant Bonding and Self-Ecacy: non-randomized clinical trial

Background: Premature birth and postpartum hospitalization can hurt the father-newborn bonding and fathers’ self-ecacy in the care of the newborn. This study was conducted to investigate the effect of the involvement of fathers with premature newborns on paternal-infant bonding and self-ecacy based on developmental care principles. Methods: This was a non-randomized clinical trial. Eighty fathers of hospitalized newborns in the neonatal intensive care unit were selected by convenience sampling method and divided into two groups ( 1 ). The intervention comprised training developmental care to fathers through simulations and then at the bedside of the newborn and the active involvement of fathers in the care of premature newborns admitted to the NICU. Pre-and post-intervention outcomes (after four weeks) were collected using Mother to Infant Bonding Scale and Perceived Maternal Parenting Self-Ecacy tool. Differences between groups were analyzed using independent t-test, paired t-test, repeated measures ANOVA. Results: The mean bonding score reduced by 2.3 ± 2.17 in the control group and 5.27 ± 2. 57 in the intervention group. A lower score represents a better bonding (f (1.78) = 9.19, p = 0.003). The self-ecacy score increased in both groups however, it was signicantly higher in intervention group. In the intervention group increased by 8.85 ± 5.046, and in the control group, it increased by 1.27± 3.31, (f (1.78) = 21.88, p <0.001). Conclusions: Developmental care by fathers training and involvement in care can improve the father infant bonding and increase the paternal self-ecacy for the care of the high risk newborn. Trial registration: Iranian Registry of Clinical Trials: 2018-01-31.


Background
About 8% of newborns in developed countries and 25% of newborns in developing countries are premature (2). Worldwide for every 10 births, one is preterm. More than 60% of preterm neonates are born in Africa and South Asia. According to studies conducted in Iran, the birth rate of premature newborns was reported to be 10% (3). Premature births and hospitalization can cause many challenges for the newborn and the family, including the disturbance in parent-neonate communication and the self-e cacy (4).
In the most cases parents of a premature newborn who needs intensive care feel frustrated and this situation might lead to separation of parents from newborn (5). When a newborn is born too early, parents may feel a big difference between what has happened and what they had expected (6). Mothers cope with it through collaborative and non-collaborative behaviors, such as looking, touching, talking, hugging and talking to others (7). But fathers may feel that they have a limited role in taking care of the newborns (8). Even though nurses often consider mothers as the main caretakers, is it common that fathers are in fact the rst ones who visit the newborns in the neonatal intensive care unit (NICU) because the mother may not be well enough following delivery (9). Moreover, routine clinical care does not provide enough opportunities for the empowerment of fathers and makes it di cult for them to accept the paternal role (4). The importance of establishing an immediate mother-infant bond has overshadowed and postponed the efforts of researchers to work on factors and interventions that affect father-infant bonding (10).
In some cases, it is reported that fathers are more likely to be affected by the neonatal illness during hospitalization in the NICU than mothers. However, their bonding with the newborn progress slowly due to limiting conditions in NICUs (4). Theorires related to mother-infant bonding include quality themes, interventions, and outcomes that may translate into the concept of father-infant bonding. As a representative case, researchers analyzing positive bonding behaviors of fathers found that fathers demonstrate some of the same behaviors as mothers but progress from passive to active involvement such as prolonged gazing, holding the infant in an en face position ,vocalizing distinct characteristics of the infant,, smiling, and being in close proximity to the infant (10). Paternal absenteeism is associated with poorer developmental, behavioral and educational outcomes that directly affect the behavior of the newborn and the child and indirectly may contribute to cause marital problems. Also, lack of paternal involvement can increase of the levels of stress hormone in mothers during the pregnancy (11).
Futhermore, research has shown that paternal-infant bond is greater in newborns whose fathers involved in their care, and that these newborns are more resisiliant during stressful conditions and in their future lives they show more courage and are more willing to explore unfamiliar surroundings ((5), (7), (11), and (12)). Successful father-infant bonding in the immediate postpartum period has been shown to decrease cognitive delay, enhance weight gain in preterm infants, and improve breastfeeding rates. Therefore; interventions that establish an immediate father-infant bond may have a positive effect on active paternal involvement as the infant grows and develops(10).
One of the negative consequences of a newborn's admission in the NICU is lack of paternal-infant bonding (13). Bonding is a relationship between two individuals that is special and lasting (14). The word bonding describes how parents feel about the newborn ((15), (16)). Bonding may not always be established as soon as the rst contact with the neonate, and can be a more gradual and constructive process, that intensi es with time (17). The timetable for creation of bonding is different in fathers and mothers. During pregnancy, mothers experience a signi cant increase in bonding (18). But bonding in fathers often develops slowly compared with mothers (18) occurring in the rst few days after the delivery during which the father forms a special permanent relationship with the newborn during the time (19).
One of the main factors in successful paternal-infant bonding is parental self-e cacy (3). Self-e cacy is an individual's perception of his competencies to perform a particular task or behavior (20). Self-e cacy affects how people think, feel and act, and is one of the factors in human motivation (20,21). When one feels more self e cacy, it is more likely one will achieve his goals and mastery of a task (2). Parental selfe cacy is their perception of the ability to play a caring role for the newborn and to provide positive conditions for the growth and development of the newborn (20). Parents who do not have enough self-e cacy are more likely unable to provide a high quality care for their newborn and it will negatively in uence the sense of bonding (22).
One method of applying neonatal care is using an individualized developmental care approach. This approach is based on the philosophy of respecting the special needs of preterm newborns. Preterm newborn's brains and body systems are vulnerable, and they are admitted to the developmentally unexpected environment of the NICU and deprived of the parental routine care because of hospitalization.
Such care, based on the families' different needs and culture, helps them to adapt to the environment and create a parental sense through active involvement in the newborn's care (18). One of the basic foundations of developmental care is family-centered care (23). The potential bene ts of a familycentered approach include improving parental satisfaction by involving them in the care and decisionmaking, reducing parental stress, increasing the ability of parents to cope with the newborn's apparent condition and behavior as well as improving the breastfeeding, increasing parental relaxation and empowerment to provide care for their newborns after discharge (24).
So far, many studies focused on the involvement of mothers, their self-e cacy and maternal-infant bonding, but there is insu cient information about fathers, and also the care based on the principles of developmenta care, especially since cultural issues and beliefs governing the family and society, such as those in developing countries, can in uence paternal direct involvement in the care of the premature newborn both in the hospital and the NICU. Nurses may be more concerned with the involvement of mothers in the care and may ignore the needs of fathers and may not consider a paternal role in the care of newborns (13).
In Iran as a result of cultural religious beliefs Fathers' long presence in the ward interferes with mothers' caregiving and in many cases mothers, religious beliefs prevent them from breastfeeding or providing skin to skin care with men present. For the same reason, nurses also may feel uncomfortable, from their point of view NICU is a feminine workplace and they are more comfortable with the mothers rather than fathers. Moreover, organizational barriers such as hospitals' visiting policies limit the fathers' presence and in the majority of thehospitals, and they are allowed to visit their newborns only during speci c hours (25).
Despite similarities in bonding behaviors between mother and father and the infant, fathers may need interventions that are directly related to the phenomenon of father-infant bonding (10). The present study aimed to investigate the effect of the involvement of fathers of premature newborns on paternal-infant bonding and self-e cacy based on developmental care principles.

Study design
The present study was nonrandomized clinical trial (two group [Control, Intervention], pre-post test design) which investigated the effect of the involvement of fathers of premature newborns on paternal-infant bonding and self-e cacy based on the principles of developmental care. Data was collected from from April 2018 to March 2019.

Study setting and sample
A convenience sample was selected among fathers of premature newborns admitted to the NICU. The study setting was the NICU of Arash Hospital a liated to Tehran University of Medical Sciences. The sample size was calculated to be 40 individuals by using the formula with type I error of 5%, type II error of 20%, and a standard deviation of 4.6 which could detect at least 5.2 units in the neonatal bonding score (26). Fathers were included if they had a premature newborn with a gestational age less than 37 weeks, were able to comprehend, read and respond in the Persian language, had no history of addiction and/or psychiatric illness and no previous preterm newborns. Newborns with a lifelimiting disease during the study, such as lung hemorrhage or intravenous cerebral hemorrhage, having mothers with depression or postpartum psychosis during the study, newborns admitted for more than four weeks and newborn's discharged earlier than one week were excluded from the research. Data collection included obtaining demographic information about newborns and parents. Father's age, mother's age, father's job, and economic status were collected. The variables related to the newborn included the sex, the age, the length of stay, the type of birth, the type of pregnancy, the birth order, the cause of admission, and the type of feeding. The process of data recruitment is presented in gure 1.

Measurements
In this study, the Mother to Infant Bonding Scale (MIBS) was used to examine the relationship between the father and the newborn. It is a 10-item questionnaire based on Likert scale and examines the parentinfant bonding in the form of rejection, liking or no reaction towards the newborn. Scores range from 0 to 30. The low score indicates a good bonding and a high score indicates a poor bonding. The reduction in this score re ects the improvement in the paternal-infant bonding. This tool has two factor structures of lack of affection (LA) and anger and rejection (AR).In a study conducted in Portugal in 2007 the researchers used a same scale for both parents. So, they used 'New Mother-to-Infant Bonding Scale' , in order to study mother-to-infant and father-to-infant initial emotional involvement and differences between mothers. According to there results maternal and paternal emotional involvement toward the newborn tend to be similar and no signi cant differences were found between them either for most items or for the positive and negative subscales (17) .
The internal consistency of the tool was calculated to be 0.71 and 0.57 for LA and AR in the original study. After obtaining permission from the original designer, the questionnaire was rst translated into Persian. Subsequently, it was back-translated into English by a uent translator who did not have access to the original questionnaire, then it was compared to the original one. To validate the validity of the questionnaire, ve faculty members and ve nurses working in the NICU assessed the face validity of the instrument. After considering their opinions, the questionnaire was given to 15 fathers whose newborns were admitted in the NICU. The same fathers completed the questionnaire after two weeks again. The correlation of scores was 0.61 and (P <0.001) in both times (26).
Fathers' self-e cacy was examined with Perceived Maternal Parenting Self-E cacy (PMP SE) PMP S-E.
The questionnaire has 20 items that examine the paternal perceived self-e cacy. Barnes & Adamson designed this instrument in 2007. The items include four items related to care processes, seven items related to motivational behaviors, six related to the perception of behaviors and messages, and three related to situational beliefs. Scoring is based on four-point Likert scale including strongly disagree (score = 1), disagree (score = 2), agree (score = 3), strongly agree (score = 4). Scores range from 20 to 80. High scores re ect a high level of self-e cacy. The internal consistency of the tool was 0.91 in the initial study. This tool was translated into Persian in the study of Franak Aliabadi in 2013, and its validity and reliability have been con rmed (α = 0.97) (20).

Procedures
The fathers were entered into the study sequentially from each group to prevent the transmission of information between the units of the Intervention and the Control groups. Samples were included in 8 groups of 10 subjects, respectively. The rst ten subjects were assigned in the Intervention group by coin ipping, and the other ten subjects were assigned in the Control group. None of the groups were studied in the same time interval to prevent contamination of the information. This sequence continued until the end of the sampling, and the next group did not enter the study until the discharge of the newborn and the departure of the last father of the group. The new sample would have been replaced in case of a sample withdrawal due to exclusion criteria.
The research objectives were explained for fathers. Written and informed consent was obtained from them. Research instruments including demographic characteristics, mother to infant bonding scale, and parents' self-e cacy were completed at baseline. In the Intervention groups, a developmental care program was performed. The intervention included four 90-minute sessions. During the rst session, the environment of the NICU, both parents were educated on the characteristics of the premature newborns and their needs, with particular attention paid to the father. Then, the father and researcher attended the newborn's bedside, and he hugged and touched the newborn with the support of the researcher. At the second session, the developmental care philosophy and how to care for the newborn were presented on a Marquette based on the principles of developmental care. The trained care included positioning, proper handling, newborn feeding, skin to skin care, bathing, swaddling, changing diapers, touching the newborn, and understanding the newborn's behavior. After learning the materials mentioned above, the father performed the tasks according to the needs of the newborn (feeding, changing diapers, skin-to-skin care, etc.). The father practiced the care of the newborn in the presence of the researcher during the third and fourth sessions. If needed, he answered the questions of the researcher. Fathers were asked to complete the two outcome measures four weeks after the intervention. If the newborn was discharged, the questionnaires were completed by phone call or at the time of follow-up referral. In the control group, the questionnaire was completed at the beginning of the study and four weeks later.

Statistical Analysis
Data were analyzed using SPSS 16. Self-e cacy and bonding scores were rst examined by Shapiro's test, and the normal distribution of scores was con rmed. Between group differences in self-e cacy and bonding scores were tested before and after the intervention by independent t-test, paired t-test and repeated measures ANOVA.

Results
There were no signi cant differences in terms of gestational age, fathers age, mothers age and the number of admission days in two groups. The characteristics of the newborns and the fathers are reported in Table 1. . "There was a statistically signi cant correlations between the lack of affection and the anger-rejection sub-scales on the MIBS scale (r = 0.389, p < 0.001). Fathers showed higher Anger and Rejection scores than the Lack of Affection in both groups. In the Control group, the score of this dimension continued to be higher than Lack of Affection after four weeks. However, in the Intervention group, this dimension was signi cantly lower than in the Control group. Also, the Intervention group signi cantly decreased the score of Lack of Affection indicating improved paternal-infant bonding in this dimension ( Table 2). .88, p < 0.001). Self-e cacy increased in both groups in dimensions of the care process, the perception of behaviors and messages and situational beliefs after four weeks. However, the level of self-e cacy has decreased in the relaxation technique dimension in both groups, but such a decrease in the Intervention group was lower than that of the Control group. Also, there was a signi cant difference between the Control and Intervention groups in the care process before the intervention indicating the self-e cacy of fathers in the Control group was greater than that of the Intervention group fathers before the intervention. The self-e cacy level in this dimension increased in both groups after four weeks, but the Intervention group had a greater increase in self-e cacy score in this dimension compared with the control group (P < 0.001).

Discussion
The current study aimed to investigate the impact of involvement of Father's with Preterm Newborns care on father-infant Bonding and self-e cacy based on developmental care principles.
Acording to Iranian religious and their traditional look at the presence of men in the unit, long term presenns of fathers are not easily welcomed. Some nurses and mothers believe their presence prevent mothers from providing sking to skin care and breast feeding.Therefore; thoughtful attention should be be paid to integrating fathers into neonatal care (27).
The results of this study showed that bonding increased in both the control and intervention groups four weeks after birth, but in the Intervention group, the increase was signi cantly more than in the Control group. In addition, self-e cacy scores signi cantly increased in both groups after four weeks, indicating an improvement in self-e cacy. The fathers of the Intervention group signi cantly greater increases bonding and self-e cacy scores compared with fathers of the Control group.
The mother to infant bond has two dimensions of lack of affection and anger-rejection. The anger and rejection had a higher score than lack of affection, showing that fathers had more di culties in this dimension. In the Control group, the scores in this dimension were still higher than the lack of affection after four weeks. But in the Intervention group, the scores of this dimension decreased signi cantly compared to the Control group. Also, the score of lack of affection signi cantly decreased in the Intervention group, showing improvement of the paternal-infant bonding in this dimension.
This study is one of the few that has examined the effect of developmental care on the paternal-infant bonding. Several studies have been done on the maternal-infant bonding. In a study in Japan on maternal-premature newborn bonding, a high score of lack of affection was associated with decreased interest in the care of the newborn, and there was a negative feeling toward the newborn in the dimension of anger and rejection. However, there was a moderate correlation between the two dimensions of lack of affection and anger-rejection, showing that positive affections towards the newborn is not against anger and rejection. It means that parents can love their newborns with a sense of anger and rejection and they cannot have a lack of affection (26).
In a study conducted in Portugal, the contribution of fathers to cutting the umbilical cord improved the process of bonding between father and newborn (28). In our study, there was a strong relationship between the two dimensions of lack of affection and anger-rejection, and fathers in both groups had higher scores in the dimension of anger and rejection. Because of this correlations, change in one factor can alter the other. Therefore, it is important to consider the relationship between the father and the newborn at the earliest opportunity. A cultural difference between Iran and Japan could be one of the reasons for this difference in our ndings.
The self-e cacy of the fathers in the Intervention group in the present study was signi cantly higher than that of the Control group. Pennell's study showed that targeted interventions that improved the selfe cacy of parents could reduce the mental impacts of parental perceptions of their competency (1). Targeted interventions included the involvement of parents, especially fathers. With the involvement of fathers in the care of newborns, a sense of competence and self-e cacy is created in the father.
Increasing the self-e cacy of the father is directly related to effective communication with the newborn. A study in Iran examined the effect of virtual space-based educational support on satisfaction and selfe cacy of mothers of newborns admitted to NICU, and showed a signi cant increase in the level of selfe cacy in the intervention group (29). The care process dimension of the PMPS-E questionnaire was not signi cantly different before and after the intervention. But dimensions of relaxation technique, the perception of behavior and messages, situational beliefs in PMP SE increased signi cantly.
However, in the present study, the self-e cacy score in the dimensions of the care process, the perception of the behaviors and messages, and situational beliefs increased in both groups, but it reduced in dimension of the relaxation technique. This decrease was lower in the Intervention group than in the Control group indicating the effect of the intervention.
The Care Program of Melnyk et al., (2006) aimed at reducing the length of stay of premature newborns.
Here, educational content was provided for parents in the form of audio tapes and workbooks. This training program reduced parental depression, tension, and improved their beliefs. But there was no signi cant difference in the interaction between the parent-infant, (30). In our study, with the direct involvement of the father in the care and presence of a researcher at the bedside, fathers could interact with the newborn with a sense of tranquility. The greater theamount of this interaction, the greater the sense of self-con dence, the relationship between the father and the newborn, and self-e cacy of the father will be. The questionnaires were completed before presenting the lm and 1-2 days before discharge. The results showed that the knowledge of fathers about neonatal behavior increased, and contrary to the results of the Melnyk training program, such an increase in knowledge promoted paternal sense and parenting tasks (13). Finally, a study on family-centered interventions to increase the relationship between parents and newborns in the NICU concluded that the level of knowledge, dependence, and interactions in the Intervention group was higher than that of the Control group (31).

Study Limitations
The main limitation of the study was using semi-experimentsl method. There was no other option rather than using semi-experimental method to eliminate the possibility of data contamination, however the results showed that it can be the involvement of fathers can increase their ability of taking care of their infant signi cantly.

Conclusion
Implementing a care program in the NICU that takes into account the role of each family member in the development of the newborn may help improve family dynamics and developmental outcomes (30).
Because of the direct in uence of the presence of the father on the newborn's life and the developmental outcomes, the paternal involvement in care in the NICU is necessary. The results of the current study showed that the creation of an emotional bond between the father and the newborn is possible and the greater the rate of the father's involvement in the care of the newborn, the higher their self-e cacy and potential for improved outcomes of these vulnerable infants. The study protocol was approved by the Ethics Committee of the Tehran University of Medical Sciences (IR.TUMS.FNM.REC.1396.2241). The study was registered in Iranian registry of clinical trials (IRCT20171010036690N1). All fathers completed informed written consent. All fathers could withdraw from the study whenever they desired. The information on all research units was con dential.

Consent for publication
Not Applicable Availability of data and materials All data will be available on request. All request should sent to the corresponding author email and they will be availebele within 0ne week.

Competing interests
There is no competing interest in the designing or reporting of the study.

Funding
The study was a MSc thesis and Tehran University of Medical Sciences funded the study as a research project in the data collection phase. Figure 1