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

Recruiting now

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT07463170

Run by

Assistance Publique - Hôpitaux de Paris

People needed

50

Starts

2026-06-02

Expected to finish

2026-09-01

Last updated by the study team

2026-08-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Licensed healthcare professionals currently working in a neonatal care unit.
• Healthcare professionals authorized by their professional qualifications or regulations to assess patient pain, including nurses, specialized nurses, and physicians.
• Healthcare professionals employed at AP-HP (Assistance Publique - Hôpitaux de Paris).

You may not qualify if…

• Refusal to participate, indicated by non-response to the questionnaire.

Where it is running

• Centre d'Evaluation et de Traitement de la Douleur, Médecine Palliative (CETD-MP) — Paris, Île-de-France Region, France (enrolling)

Full record on ClinicalTrials.gov

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