Pain Assessment Clinical Trial
— BERN-PAINOfficial title:
Validation of the Bernese Pain Scale for Neonates With Consideration for Contextual Factors
Verified date | August 2017 |
Source | Bern University of Applied Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 156 |
Est. completion date | January 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 24 Weeks to 41 Weeks |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Lawrence S. Bloomberg Faculty of Nursing and Faculties of Medicine and Dentistry, University of Toronto | Toronto | |
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 |
Lead Sponsor | Collaborator |
---|---|
Bern University of Applied Sciences | University Children's Hospital Basel, University Hospital Inselspital, Berne, University of Toronto, University of Zurich |
Canada, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain response across time | Change and variability of pain response across different time points will be measured with the BPSN | 2-5 timepoints within the first 14 days of life | |
Secondary | Influence of individual contextual factors on pain response across time | 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. | 2-5 within the first 14 days of life | |
Secondary | Psychometric testing of the BPSN | Psychometric testing will be done across all the five time points for baseline, heel stick and recovery phases | 2-5 timepoints within the first 14 days of life |
Status | Clinical Trial | Phase | |
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