French translation and adaptation of the COMFORTneo pain tool for newborns
Official title: Translation and Cross-Cultural Adaptation Into French of the COMFORTneo Pain Assessment Tool for Newborns
Run by Assistance Publique - Hôpitaux de Paris · NCT07463170 · Data updated 2026-11-12
This project tests a French translation of the COMFORTneo pain assessment tool for newborns to help doctors and nurses in Paris identify pain in term and preterm babies.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Status | Recruiting |
| Started | June 2, 2026 |
| Main results expected | August 2, 2026 |
| Study ends | September 2026 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07463170 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Licensed healthcare professionals working in neonatal care units in AP-HP who are authorized to assess neonatal pain.
✕Probably not a fit
The study does not involve direct patient interventions, so individual patient benefit is not expected.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational effort focuses on translating and culturally adapting the COMFORTneo pain scale for use in French neonatal care settings. It involves an expert committee review and pre-testing to ensure the tool is appropriate for newborns across varying clinical conditions and ventilation statuses. The study targets healthcare professionals who assess pain in neonates within AP-HP facilities, to determine usability and consistency with existing French pain scales. No patient-level intervention is performed; the emphasis is on measurement validity and practical adoption in routine care.
Why it matters
Potential benefit: If successful, the French version of COMFORTneo could improve the accuracy and consistency of neonatal pain assessment in French-speaking units.
How similar studies have gone: Prior translations of neonatal pain scales exist in French, supporting the feasibility of cross-cultural adaptation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: \- Refusal to participate, indicated by non-response to the questionnaire.
Where it's running
-
Centre d'Evaluation et de Traitement de la Douleur, Médecine Palliative (CETD-MP)
Paris, Île-de-France Region, France Recruiting
Study contacts
- Study coordinator: Louise CHARRIE
- Email: louise.charrie@aphp.fr
- Phone: 01 44 38 18 65
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.