Uppsala University Hospital
Uppsala, Sweden
NCT Number: NCT07561047
This observational study aims to evaluate skin conductance monitoring as a continuous method for pain assessment in postoperative neonates. Pain assessment in newborns is challenging due to their inability to communicate, and current methods rely on intermittent observational scales such as the Neonatal Pain, Agitation and Sedation Scale (N-PASS) in combination with physiological parameters.
Skin conductance reflects sympathetic nervous system activity and provides a continuous, objective measure of stress and pain. This study will investigate the correlation between skin conductance measurements and standard clinical pain assessment tools (N-PASS and vital parameters), as well as explore the potential analgesic effect of skin-to-skin care.
The study is conducted in a neonatal intensive care unit (NICU) setting where all monitoring and treatments are part of routine clinical care.
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Observational
Uppsala, Sweden
Exposure to pain in the neonatal period is associated with adverse short- and long-term outcomes, including altered neurodevelopment. Accurate pain assessment is therefore essential but remains challenging due to the lack of a gold standard.
Currently, pain assessment in neonates relies on observational tools such as N-PASS, which incorporates behavioral and physiological indicators. However, these assessments are intermittent and subject to observer variability.
Skin conductance monitoring is an objective and continuous method that measures sympathetic nervous system activity through electrodermal responses. Previous research has demonstrated that skin conductance can detect stress and pain responses even in extremely preterm infants.
In this study, postoperative neonates admitted to the NICU will be continuously monitored using skin conductance for approximately 72-80 hours following surgery. Routine clinical pain assessments using N-PASS will be performed at regular intervals, alongside continuous monitoring of vital parameters.
Additional clinical data will be collected from electronic medical records, including demographic characteristics, perinatal history, surgical details, postoperative recovery parameters, and analgesic treatments.
The study is purely observational, and no interventions beyond standard clinical care will be introduced.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 72-80 hours post surgery
The correlation between pain assessment using skin conductance monitoring compared to pain assessment using the visual pain assessment scale N-PASS in combination with changes in vital parameters
Contact information is provided by the study sponsor or research team.
Johanna Tidehag Walan, MD, PhD-student
CONTACT
Richard Sindelar, Professor
CONTACT
Uppsala University
Other
Postoperative Pain Assessment in Newborns Using Skin Conductance Measurement
Acronym: Poppi
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