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NCT Number: NCT07561047

Postoperative Pain in Infants

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Skin conductance correlation to N-PASS

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Johanna Tidehag Walan, MD, PhD-student

CONTACT

[email protected]

+46704184255

Richard Sindelar, Professor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Postoperative Pain Assessment in Newborns Using Skin Conductance Measurement

Acronym: Poppi

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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