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

Abstract

Background During 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/design A 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). Discussion Parental 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 registration ClinicalTrials.gov (NCT04341194) 10 April 2020.

“Thai Nurses’ and Midwives’ Perceptions Regarding Barriers, Facilitators, and Competence in Neonatal Pain Management”

“…Importantly, parental involvement was identified as facilitating pain relief among neonates. This is consistent with existing research46,47 regarding family-centered care (FCC) and HCPs’ perceptions of parents’ role in neonatal pain management and in visitation. Parents who presented during painful procedures reported lower distress and more satisfaction with care and felt empowered in their caregiving role 46,47.…”

“…This is consistent with existing research46,47 regarding family-centered care (FCC) and HCPs’ perceptions of parents’ role in neonatal pain management and in visitation. Parents who presented during painful procedures reported lower distress and more satisfaction with care and felt empowered in their caregiving role 46,47. Unfortunately, implementing parent involvement into Thai NICU practice remains challenging due to the healthcare delivery system and the attitudes toward FCC.…”

“…Parents who presented during painful procedures reported lower distress and more satisfaction with care and felt empowered in their caregiving role. 46,47 Unfortunately, implementing parent involvement into Thai NICU practice remains challenging due to the healthcare delivery system and the attitudes toward FCC. Some participants reported that they did not necessarily desire parental presence during painful procedures and the COVID lockdowns negatively influenced parental involvement in neonatal pain care.…”

State of the Art in Parent-Delivered Pain-Relieving Interventions in Neonatal Care: A Scoping Review

“…The combination of the parent's voice, skin, warmth, breathing rhythm, taste, and scent fully match and harmonize with the infants' multisensory, biopsychosocial state of being. However, more research in combined parent-delivered interventions, research that also includes relationship-based interventions such as the parent's attuned live singing in parent-delivered pain management, is obviously necessary ( 130 ).…”