Translation and Cross-Cultural Adaptation Into French of the COMFORTneo Pain Assessment Tool for Newborns

Observational pain assessment scales are essential for the management of pain in young children, particularly in newborns. Numerous observational pain assessment scales for newborns and preterm infants exist worldwide; however, only four are available in validated French versions: EVENDOL, EDIN, DAN, and Comfort-B, each with specific indications for use. These scales were developed in France, validated in French, or recommended by expert groups (Comfort-B). The COMFORTneo scale was developed and validated by a Dutch research team for the assessment of pain in term and preterm newborns, regardless of their level of ventilation or sedo-analgesia. Although it has been validated in several languages, no validated French translation is currently available.

NCT Number	NCT07463170
Lead Sponsor	Assistance Publique - Hôpitaux de Paris Collaborators: URC-CIC Paris Descartes Necker Cochin
Conditions	Pain
Enrollment	50 participants
Start Date	2026-06-02
Primary Completion	2026-08-02 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2026-08-10