Study protocol: parents as pain management in Swedish neonatal care – SWEpap, a multi-center randomized controlled trial

Parents are a valuable but often overlooked resource in procedural pain management in newborn infants. The influence of the parent is particularly salient in early infancy and in extremely distressful situations such as painful procedures, because infants lack the resources to successfully self-regulate. Therefore, infants need an emotionally available and stable parent who responds adequately to the infant’s distress signals and who is able to soothe, regulate and share the infant’s states [1]. In the Nordic countries today, the concept of family-centered care (FCC) is considered best practice in the care of the newborn [2, 3]. Since the 1990s, FCC has been and still is, part of an ongoing paradigm shift where family involvement in the infant’s care and the parent-infant relationship are of central importance, a cornerstone in current neonatal and pediatric health care [4, 5]. Nonseparation of parents and infants is a protective measure in decreasing stress in both parents and infants [6] and should also be applied in painful procedures [7].

As part of routine postnatal care, all infants experience recurrent painful procedures early in life with blood sampling for newborn metabolic screening and immunization programs. Infants in the neonatal intensive care unit (NICU) receive the highest amount of pain exposure, on average between 7 and 17 painful procedures per day [8]. Far from all infants receive adequate pain management during procedures (Shah & Siu 2019, [9, 10]). Untreated pain leads to unnecessary suffering but also leaves the newborn infant at risk for long term negative consequences from the pain. Research have shown detrimental effects of repeated painful experiences in the newborn infant including altered cortical development [11, 12], altered pain processing, increased internalizing behavior [13] and long-term effects on cortisol response [14]. For infants born preterm, neonatal pain-related stress was associated with alterations in both early and in later developmental outcomes [15].

During the last decade, parents’ participation in infant pain management has become a focus for research in nursing pain science (e.g. [16‐20]). Parental presence has been shown to increase documentation of nursing pain assessment and of the use of non-pharmacological pain-relieving methods such as skin-to-skin contact (SSC) and breastfeeding, and decrease the infant’s pain intensity and behavioral distress [21, 22]. Parents have a unique knowledge and perspective of their infant’s needs and personality and can be effective partners in the care of the infant, including pain management, if they are acknowledged by the health professionals [20, 23]. Not all parents are able to provide emotional and physical closeness, many parents do not know how to effectively comfort their child during a medical procedure, and some do not feel confident doing so [24]. But most parents experience a feeling of helplessness in their inability to protect their infant from pain during procedures [25, 26]. Therefore, health professionals need to safeguard parent-infant proximity, reciprocity, and establishment of parental responsibility, which are all essential factors for the parent-infant attachment process [26]. Interventions to improve parents’ knowledge and involvement in infants’ pain management are essential to implement in the care of the newborn infant [26]. Parents need to and want to participate actively in their infant’s pain management, and parents should receive education and guidance in various format, not just verbal information, on how to mitigate their infant’s pain [23, 24, 27‐31].

Pain alleviating pharmacological agents such as oral sweet solutions, i.e. sucrose and glucose, are today part of standard care in neonatal and postnatal care and are considered to have a calming and analgesic effect on infants during painful procedures [32]. Sweet solutions have been extensively investigated and found to reduce procedural pain from blood-sampling procedures in preterm, term infants and infants ≤12 months old, without serious side effects [33]. However, there is a consensus that non-pharmacological strategies should be the first choice in procedural pain management for infants because there are no adverse effects and parents can be involved using these approaches safely [23, 34, 35]. Non-pharmacological pain management involves interventions driven by nurses and/or parents. Just like oral sweet solutions, swaddling, containment or facilitated tucking, positioning, non-nutritive sucking and recorded music stimulation, are nurse-initiated pain alleviating interventions where parents can be included but parental presence is not required [32, 36]. Among the non-pharmacological approaches, the biopsychosocial perspective strongly supports parent-driven interventions [37]. In the parent-driven non-pharmacological interventions, the parent herself/himself is a mediator for pain relief [36]. Parent-driven non-pharmacological interventions are consistent with modern family-centered care in which the best interests of the infant and family are put ahead of staff convenience [36]. SSC, breastfeeding and live singing are simple and cost-effective evidence-based interventions that may modify the infant’s pain and stress if the strategies are well-timed [38‐41]. SSC is a method widely used in postnatal care globally. A significant amount of research has also shown the pain-relieving effect of skin-to-skin contact during painful procedures in newborn infants [19, 42]. Breastfeeding has demonstrated efficacy that is equal to, or greater than, sweet taste interventions in reducing behavioral and physiological responses to pain in full-term infants undergoing venipuncture with no demonstrated adverse outcomes [38]. Live parental infant-directed lullaby singing, informed by music therapy research, has not been previously investigated during painful procedures. It has been confirmed in previous research in non-painful contexts that live parental lullaby singing is an individually tailored, non-verbal, multisensory, affective, relationship-based tool useful in regulating the infant, augmenting the parent’s focus on the infant in the moment, enhancing the parent’s emotional availability and responsiveness and decreasing stress in the dyad [43‐45]. Previous research with recorded music stimulation with instrumental lullaby music, selected in consultation with an accredited music therapist, has shown similar effect to the current gold standard of oral sucrose [46], and the combination of music stimulation with sucrose provides better pain relief during blood sampling than when sucrose or music is used alone [46]. Recorded mother’s voice has also shown similar pain alleviating effects as oral sweet solutions [47, 48].

Neonatal pain research has studied a range of non-pharmacological pain alleviating strategies during painful procedures. However, there is a dearth of research about combined multisensorial parent-driven non-pharmacological pain management, which encompasses a combination of individual pain-relieving interventions such as parental closeness and SSC, olfactory, oral and auditory stimulation. Therefore, a multi-center randomized controlled trial with the aim to investigate the efficacy of combined pain management with SSC, breastfeeding and live parental lullaby singing, is planned in postnatal care.

This study protocol describes a randomized controlled trial where the pain reliving effects of combined parent-driven pain management during venipuncture on newborn infants will be studied. Parents are a valuable resource in procedural pain management in newborn infants, a resource which has not been addressed in research until the last decade. In the SWEpap study, we emphasize the importance of parent involvement in newborn pain management, but the key question is to address the research gap in the literature of the efficacy of combined non-pharmacological parent-driven pain management. Combined parental soothing behaviors that provide rhythmic (holding/rocking/vocalizing) or orogustatory/orotactile (feeding/pacifying) stimulation that keep the parent close to the infant, are effective in a painful context [58]. Consequently, in the SWEpap study, we include parental live lullaby singing, which is an unexplored but promising biopsychosocial, multimodal and multisensory pain alleviating adjuvant, especially in combination with SSC and breastfeeding [37]. Newborn infants are highly responsive to social and affective communication. In live parental infant-directed singing, the parent is attuned to the moment-to-moment psychological experience of the infant [43, 59]. The mainly “physical” parent-driven interventions with SSC and breastfeeding are therefore accompanied by a relationship-based intervention, the live parental lullaby singing, which may assist in modifying the painful situation for both the infant and the parent before, during and after the painful procedure [37].

In research, SSC is most often provided by mothers [60]. There are few studies exploring gender differences, mothers versus fathers, or pain alleviating differences in SSC between the mother and her partner or a non-related woman. When testing paternal versus maternal SSC to reduce pain from heel lance, mothers were marginally more effective than fathers in decreasing pain response [61]. Non-related women who provide SSC for procedural pain in preterm neonates are marginally less effective than mothers at decreasing pain response [60, 62].

Within the interdisciplinary research field of neonatal pain, there is a small number of research studies that have addressed the parents’ voice and musical presence during painful procedures [63, 64]. However, the nature of the parents’ vocal and musical engagement with their infants was not systematically reported. The parental live singing was not described and differentiated from “babytalk”, reciting of nursery rhymes or reading a story [64]. In general, live infant-directed singing is considerably more effective than infant-directed speech in lowering infants’ elevated arousal levels and ameliorating distress [65]. Analyses of parents’ singing to their infant in a non-painful context, have revealed similarities in the singing style of mothers and fathers, for example fathers, like mothers, adjust their singing with slower tempo and with warmer vocal tone when singing to infants than in other contexts [66, 67]. The soothing, comforting and emotion regulating properties of a lullaby are well-known cross-culturally and historically [65]. To date, research about parental infant-directed singing has focused primarily on the importance of the mother’s voice, but the possibility for fathers and partners to partake in live lullaby singing with their infant may facilitate a more equal parenthood [68, 69].

In the SWEpap study, multiple methods will be used when assessing the infants’ pain; GSR which comprises neurophysiological signs of pain and stress, and PIPP-R which is a widely used and validated pain assessment instrument. In addition, according to the parent-driven practice where parents are integrated in procedural support, the parents in the SWEpap study will also be assessing their infant’s pain. Pain assessment is as subjective as the pain experience itself and it is important to recognize the reciprocal relationship between infant and parent in a pain assessment context [39]. Parents are acknowledged as having a crucial role in assessing the infant’s pain and taking appropriate action to manage it [70]. Research has also shown that the parent’s assessment is not always based on the infant’s behavior [71] and may therefore differ from the health care professionals’ assessment [72].

To reduce the risk for selection bias in this study, broad inclusion criteria will be used including also parent-infant dyads from other cultures who understands English or Swedish, which strengthens the results and generalizability. A strength in this study is that data collection will take place in four hospitals in diverse health care regions in Sweden which will hopefully increase the scientific quality by recruiting a large sample size within a feasible time period, increasing the generalizability to other settings and reduce the risk of recruitment bias. The allocation with group 2a and b, referring to two different groups receiving skin-to-skin contact, might be considered as problematic. However, performing clinical research sometimes makes it difficult to use standardized procedures. It is not ethically feasible to defer from already existing guidelines and, in this study, preventing mothers from breastfeeding if applicable. It is important to focus on relevant clinical situations where the results can be useful for the patients, families and various health care settings and not only conducting research in laboratory surroundings. An aspect that must be taken into consideration is how to empower parents to use their voice and sing in conjunction with painful procedures. Parents might feel shy and inhibited about singing, especially in unfamiliar situations among unfamiliar people. On the other hand, research shows that most parents (60%) already sing spontaneously to their newborn during hospitalization [73]. By starting the lullaby singing together with SSC 10 min before the venipuncture and giving the parents clear instructions how the singing should be performed, we might modulate possible concerns. The use of technical equipment during the venipuncture will add a few minutes to the procedure, however the research group has previous extensive experience of similar research projects that will ensure the implementation of the study protocol.

The results generated in the SWEpap study will hopefully contribute to the interdisciplinary endeavor world-wide of involving and integrating parents in neonatal pain management and presumably also inform pain management practice in the neonatal intensive care context, where the critically ill and vulnerable hospitalized infants suffer the most from repeated, cumulative and inadequately treated procedural pain in addition to separation from the parents.