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Postoperative Pain in Infants

Postoperative Pain Assessment in Newborns Using Skin Conductance Measurement

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07561047
Acronym
Poppi
Enrollment
100
Registered
2026-05-01
Start date
2026-06-01
Completion date
2029-06-01
Last updated
2026-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

skin conductance monitoring, postoperative pain, neonate, preterm infant

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Neonates admitted to the NICU * Undergoing surgical intervention * Receiving postoperative care at the study site

Exclusion criteria

* Major heart surgery * No parental consent

Design outcomes

Primary

MeasureTime frameDescription
Skin conductance correlation to N-PASS72-80 hours post surgeryThe 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

Countries

Sweden

Contacts

CONTACTJohanna Tidehag Walan, MD, PhD-student
johanna.walan@uu.se+46704184255
CONTACTRichard Sindelar, Professor
richard.sindelar@uu.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 2, 2026