Abstract
BackgroundDuring the first period of life, critically ill as well as healthy newborn infants experience recurrent painful procedures. Parents are a valuable but often overlooked resource in procedural pain management in newborns. Interventions to improve parents’ knowledge and involvement in infants’ pain management are essential to implement in the care of the newborn infant. Neonatal pain research has studied a range of non-pharmacological pain alleviating strategies during painful procedures, yet, regarding combined multisensorial parent-driven non-pharmacological pain management, research is still lacking.Methods/designA multi-center randomized controlled trial (RCT) with three parallel groups with the allocation ratio 1:1:1 is planned. The RCT “Parents as pain management in Swedish neonatal care – SWEpap”, will investigate the efficacy of combined pain management with skin-to-skin contact, breastfeeding and live parental lullaby singing compared with standard pain care initiated by health care professionals, during routine metabolic screening of newborn infants (PKU-test).DiscussionParental involvement in neonatal pain management enables a range of comforting parental interventions such as skin-to-skin contact, breastfeeding, rocking and soothing vocalizations. To date, few studies have been published examining the efficacy of combined multisensorial parent-driven interventions. So far, research shows that the use of combined parent-driven pain management such as skin-to-skin contact and breastfeeding, is more effective in reducing behavioral responses to pain in infants, than using the pain-relieving interventions alone. 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 more effective in a painful context. In the SWEpap study we also include parental live lullaby singing, which is an unexplored but promising biopsychosocial, multimodal and multisensory pain alleviating adjuvant, especially in combination with skin-to-skin contact and breastfeeding.Trial registrationClinicalTrials.gov (NCT04341194) 10 April 2020.
Highlights
During the first period of life, critically ill as well as healthy newborn infants experience recurrent painful procedures
Parental involvement in neonatal pain management enables a range of comforting parental interventions such as skin-to-skin contact, breastfeeding, rocking and soothing vocalizations
Research shows that the use of combined parent-driven pain management such as skin-to-skin contact and breastfeeding, is more effective in reducing behavioral responses to pain in infants, than using the pain-relieving interventions alone
Summary
This study protocol describes a randomized controlled trial where the pain reliving effects of combined parentdriven pain management during venipuncture on newborn infants will be studied. 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]. The mainly “physical” parent-driven interventions with SSC and breastfeeding are 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]. The results generated in the SWEpap study will hopefully contribute to the interdisciplinary endeavor worldwide of involving and integrating parents in neonatal pain management and presumably 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
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