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Validation of the Bernese Pain Scale for Neonates (BERN-PAIN)

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ClinicalTrials.gov Identifier: NCT02749461
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : August 3, 2017
Sponsor:
Collaborators:
University Hospital Inselspital, Berne
University of Zurich
University Children's Hospital Basel
University of Toronto
Information provided by (Responsible Party):
Eva Cignacco, Bern University of Applied Sciences

Brief 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.

Condition or disease Intervention/treatment
Pain Assessment Procedure: heel stick

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.


Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the Bernese Pain Scale for Neonates With Consideration for Contextual Factors
Study Start Date : November 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Intervention Details:
  • Procedure: heel stick
    Consecutive routine blood sampling heel sticks


Primary Outcome Measures :
  1. Change in pain response across time [ Time Frame: 2-5 timepoints within the first 14 days of life ]
    Change and variability of pain response across different time points will be measured with the BPSN


Secondary Outcome Measures :
  1. Influence of individual contextual factors on pain response across time [ Time Frame: 2-5 within the first 14 days of life ]
    Time points of contextual factors documentation are determined by the clinical need for routine heel stick procedures within the first 14 days of life. These time points are not fixed before hand but are based on ongoing clinical judgement during the first 14 days of life. For each clinically determined time point for a heel stick appropriate contextual factors being relevant the day of the determined heel stick date will be extracted from patient chart.

  2. Psychometric testing of the BPSN [ Time Frame: 2-5 timepoints within the first 14 days of life ]
    Psychometric testing will be done across all the five time points for baseline, heel stick and recovery phases



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Ages Eligible for Study:   24 Weeks to 41 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • Preterm infants born between 24 0/7 and 36 6/7 weeks of gestation will be included if they are expected to undergo 5 routine heel capillary blood samples during the first 14 days of life; if they are ventilated or not ventilated; and if their parents give informed consent.
  • Term infants born between 37 0/7 and 42 0/7 weeks of gestation will be included if they are expected to have at least 2 routine heel capillary blood samples during the first days of life and if their parents give informed consent.

Exclusion Criteria:

  • Grade III oder IV intraventricular haemorrhaging
  • Severe life-threatening malformation or suffer from any condition involving partial or total loss of sensitivity
  • pHa < 7.15 (umbilical cord)
  • Surgery for any reason
  • Congenital malformation affecting brain circulation and cardiovascular system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749461


Locations
Canada
Lawrence S. Bloomberg Faculty of Nursing and Faculties of Medicine and Dentistry, University of Toronto
Toronto, Canada
Switzerland
Department of Neonatology, University Children's Hospital of Basel (UKBB)
Basel, Switzerland
Neonatology, Children's Hospital, University Hospital of Bern
Bern, Switzerland
Neonatology, University Hospital of Zurich
Zurich, Switzerland
Sponsors and Collaborators
Bern University of Applied Sciences
University Hospital Inselspital, Berne
University of Zurich
University Children's Hospital Basel
University of Toronto
Investigators
Principal Investigator: Eva Cignacco, Prof. Dr. Bern University of Applied Sciences

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eva Cignacco, Prof. Dr., Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT02749461     History of Changes
Other Study ID Numbers: SNF 320030_159573
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eva Cignacco, Bern University of Applied Sciences:
preterm infants
pain
assessment
contextual factors
diagnostic accuracy