Pain Assessment Clinical Trial
Official title:
Validation of the Bernese Pain Scale for Neonates With Consideration for Contextual Factors
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.
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.
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