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Open Access 01-12-2020 | Care | Study protocol

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

Authors: Emma Olsson, Martina Carlsen Misic, Randi Dovland Andersen, Jenny Ericson, Mats Eriksson, Ylva Thernström Blomqvist, Alexandra Ullsten

Published in: BMC Pediatrics | Issue 1/2020

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.

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Title: Study protocol: parents as pain management in Swedish neonatal care – SWEpap, a multi-center randomized controlled trial
Authors: Emma Olsson
Martina Carlsen Misic
Randi Dovland Andersen
Jenny Ericson
Mats Eriksson
Ylva Thernström Blomqvist
Alexandra Ullsten
Publication date: 01-12-2020
Publisher: BioMed Central
Keyword: Care
Published in: BMC Pediatrics / Issue 1/2020
Electronic ISSN: 1471-2431
DOI: https://doi.org/10.1186/s12887-020-02356-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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