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Observational Study
. 2017 Jul 19;17(1):171.
doi: 10.1186/s12887-017-0914-9.

Individual contextual factors in the validation of the Bernese pain scale for neonates: protocol for a prospective observational study

Eva Cignacco  1 , Karin Schenk  2 , Bonnie Stevens  3 , Liliane Stoffel  4 , Dirk Bassler  5 , Sven Schulzke  6 , Mathias Nelle  7
Affiliations
Observational Study

Individual contextual factors in the validation of the Bernese pain scale for neonates: protocol for a prospective observational study

Eva Cignacco et al. BMC Pediatr. .

Abstract

Background: The Bernese Pain Scale for Neonates (BPSN) is a multidimensional pain assessment tool that is already widely used in clinical settings in the German speaking areas of Europe. Recent findings indicate that pain responses in preterm neonates are influenced by individual contextual factors, such as gestational age (GA), gender and the number of painful procedures experienced. Currently, the BPSN does not consider individual contextual factors. Therefore, the aim of this study is the validation of the BPSN using a large sample of neonates with different GAs. Furthermore, the influence of individual contextual factors on the variability in pain reactions across GA groups will be explored. The results will be used for a modification of the BPSN to account for individual contextual factors in future clinical pain assessment in neonates.

Methods and design: This prospective multisite validation study with a repeated measures design will take place in three university hospital neonatal intensive care units (NICUs) in Switzerland (Bern, Basel and Zurich). To examine the impact of GA on pain responses and their variability, the infants will be stratified into six GA groups ranging from 24 0/7 to 42 0/7. Among preterm infants, 2-5 routine capillary heel sticks within the first 14 days of life, and among full-term infants, two heel sticks during the first days of life will be documented. For each heel stick, measurements will be video recorded for each of three phases: baseline, heel stick, and recovery. The infants' pain responses will be rated according to the BPSN by five nurses who are blinded as to the number of each heel stick and as to the measurement phases. Individual contextual factors of interest will be extracted from patient charts.

Discussion: Understanding and considering the influence of individual contextual factors on pain responses in a revised version of the BPSN will help the clinical staff to more appropriately assess pain in neonates, particularly preterm neonates hospitalized in NICUs. Pain assessment is a first step toward appropriate and efficient pain management, which itself is an important factor in later motor and cognitive development in this vulnerable patient population.

Trial registration: The study is registered in the database of Clinical Trial gov. Study ID-number: NCT 02749461 . Registration date: 12 April 2016.

Trial registration: ClinicalTrials.gov NCT02749461.

Keywords: Contextual factors; Diagnostic; Pain assessment; Premature infants.

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Conflict of interest statement

Ethics approval and consent to participate

The study is approved by the Ethics Committee Bern (2015–238), the Ethics Committee northwest/central Switzerland EKNZ (2015–385) and the Ethics Committee Zurich (2015–563).

Written informed consent will be obtained from the parents according to the protocol approved by the ethics committees. In this study, no infant will be exposed to additional painful situations and no heel sticks will be performed solely for research purposes. Furthermore, the current standard of care in pain prevention will be upheld. All infants will receive oral sucrose before each heel stick.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Stratification of sample according to gestational age (GA) and expected sample numbers (n) (ELGA = extremely low gestational age; LGA = low gestational age)
See this image and copyright information in PMC

References

    1. Carbajal R, Rousset A, Danan C, Coquery S, Nolent P, Ducrocq S, et al. Epidemiology and treatment of painful procedures in neonates in intensive care units. JAMA. 2008;300(1):60–70. doi: 10.1001/jama.300.1.60. - DOI - PubMed
    1. Cignacco E, Hamers J, van Lingen RA, Stoffel L, Büchi S, Müller R, et al. Neonatal procedural pain exposure and pain management in ventilated preterm infants during the first 14 days of life. Swiss Med Wkly. 2009;139(15–16):226–232. - PubMed
    1. Johnston C, Barrington KJ, Taddio A, Carbajal R, Filion F. Pain in Canadian NICUs: have we improved over the past 12 years? Clin J Pain. 2011;27(3):225–232. doi: 10.1097/AJP.0b013e3181fe14cf. - DOI - PubMed
    1. Amercian Academy of Pediatrics, Committee on Fetus and Newborn, Section on Anesthesiology and Pain Medicine. Prevention and Management of Procedural Pain in the Neonate: An Update. Pediatrics. 2016;137(2):e20154271. - PubMed
    1. Amercian Academy of Pediatrics, Committee on Fetus and Newborn, Section on Surgery, and Section on Anesthesiology and Pain Medicine, Canadian Paediatric Society, Fetus and Newborn Committee Prevention and Management of Pain in the neonate: an update. Pediatrics. 2006;118(5):2231–2241. doi: 10.1542/peds.2006-2277. - DOI - PubMed

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