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Translation and Cross-Cultural Adaptation Into French of the COMFORTneo Pain Assessment Tool for Newborns
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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 Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2026-04
Completion Date
2026-07-01
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
Expert committee
A multidisciplinary expert committee will review all translated items of the COMFORTneo scale, including paramedical, medical, and translation professionals. Each item will be rated on a 4-point Likert scale to calculate the initial Content Validity Index (CVI).
Pre test
During the pretesting phase, items will be evaluated on a 5-point Likert scale by representative participants, and any item scored below 2/5 by more than 20% of participants will be revised. The CVI will also be recalculated for each item and overall to confirm content validity.
Locations (1)
Centre d'Evaluation et de Traitement de la Douleur, Médecine Palliative (CETD-MP)
Paris, Île-de-France Region, France