Validation of the Bernese Pain Scale for Neonates
Condition: Pain Assessment
Study type: Observational

Summary: 
      The aims of this validation study are the testing of the Bernese Pain Scale for Neonates'
      (BPSN) psychometric properties. The variability of pain reactions related to behavioral and
      physiological patterns across time will also be examined. Furthermore, the influence of
      contextual factors on the variability of pain reactions across gestational age groups will be
      explored. The results will be used for modifications of the BPSN to account for contextual
      factors in future clinical pain assessment in neonates.
    

Detailed description: 
      Preterm birth rates are rising worldwide, including in Europe. In 2014, Switzerland's rate of
      premature births reached 7.2%. Still, while significant progress in neonatal care has
      increased the long-term survival of preterm infants, other long-term outcomes remain
      problematic. As a result, affected infants commonly undergo exceedingly high numbers of
      painful procedures on a daily basis. For many, these treatment interventions take place at a
      crucial period in the development of the nociceptive and central nervous systems, i.e., at a
      developmental stage when repeated painful stimulus may induce both structural and functional
      reorganization of the nervous system and an altered pain response.

      As infants are unable to communicate verbally, clinical pain assessment in neonates,
      particularly those delivered preterm, is highly challenging. Therefore, pain responses have
      to be observed according to physiological and behavioral indicators which might vary across
      preterm infants depending on their physiological and neurological development stages.

      The Bernese Pain Scale for Neonates (BPSN) is a multidimensional pain assessment tool which
      is already widely used in clinical settings in the German speaking areas of Europe. Recent
      findings suggest that pain reaction is influenced by more than noxious stimulation alone: it
      is assumed that contextual factors, e.g., gestational age (GA) or gender, might also impact
      pain reactivity.

      The aims of this validation study are:

        -  to undertake the psychometric testing of the BPSN regarding its concurrent validity with
           the Premature Infant Pain Profile-Revised (PIPP-R), construct validity, interrater and
           intrarater reliability, specificity and sensitivity;

        -  to examine the variability of pain reactions related to behavioural and physiological
           patterns across time;

        -  to assess the influence of contextual factors on the variability of pain reactions
           across GA groups; and

        -  to examine the relationship between behavioural and physiological indicators across
           time.

      This multisite psychometric measurement study of the BPSN will use repeated measures design.
      The study will take place in three tertiary care hospitals (Bern, Zurich and Basel) in
      Switzerland. To examine the impact of GA on pain reaction and its variability, the infants
      will be stratified into six GA groups ranging from 24 0/7 to 42 0/7. Among preterm infants
      with GAs up to 36 6/7 weeks, five consecutive heel sticks within the first 14 days of life
      will be documented. Among healthy-term infants two heel sticks within the first days after
      birth will be documented. For each heel stick, measurements will be recorded for each of
      three phases: baseline, heel stick, and recovery. All phases will be videotaped and the
      child's pain reaction later rated according to the BPSN by five independent raters blinded to
      the measurement phase. Individual contextual factors of interest for this study are
      documented in a standardised way in all three participating Neonatal Intensive Care Units
      (NICUs), and can be extracted from patient charts.

      This diagnostic study is intended to validate the BPSN with consideration for contextual
      factors influencing neonatal pain responses. Understanding and embedding the influences of
      contextual factors into a final version of the BPSN-Context will help clinicians more
      accurately assess pain in the clinical setting, and will eventually help them minimize the
      pain endured by neonates, particularly preterm neonates in NICUs. For preterm infants
      requiring intensive care, adequate and efficient pain management is an important factor in
      later motor and cognitive development. The investigators hope this study will contribute to
      the prevention of negative long-term outcomes in this patient population.
    

Intervention name(s): heel stick
Intervention type(s): Procedure
Intervention description(s): Consecutive routine blood sampling heel sticks
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study includes preterm infants born between 24 0/7 and 36 6/7 weeks of gestation and
        term infants born between 37 0/7 and 42 0/7 weeks of gestation if they are hospitalised in
        a NICU in the University Hospitals in Basel, Bern and Zurich (Switzerland).
      
Keywords: preterm infants; pain; assessment; contextual factors; diagnostic accuracy