Postoperative Pain in Infants

NCT07561047 | Not Yet Recruiting

• 1 other identifier: Dnr 2026-01844-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

skin conductance monitoring; postoperative pain; neonate; preterm infant

Outcome Measures

Primary Outcomes (1)

• Skin conductance correlation to N-PASS

  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

  72-80 hours post surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neonates receiving postoperative care in a tertiary level hospital

You may qualify if:

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

You may not qualify if:

• Major heart surgery
• No parental consent

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Pain, Postoperative; Premature Birth

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Johanna Tidehag Walan, MD, PhD-student

CONTACT

+46704184255; johanna.walan@uu.se

Richard Sindelar, Professor

CONTACT

richard.sindelar@uu.se

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)