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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Content Validity and Linguistic Equivalence of the French COMFORTneo Scale — Within 1 month after the completion of the expert committee review and statistical CVI calculation.
  Evaluation of the relevance and fidelity of the translated items through a multidisciplinary expert committee. Experts will compare the back-translated English version with the original COMFORTneo items. Using a 4-point Likert scale, each item will be rated for its linguistic accuracy and clinical relevance. This process includes the calculation of the Content Validity Index (CVI). Items with low validity will be adjusted or modified to obtain the final experimental French version.
• Comprehensibility Assessment (Pre-testing phase) — Within 3 months after the completion of the pretesting phase at all clinical site
  A 4-point Likert scale will be used for each translated item, asking healthcare professionals to evaluate its comprehensibility. For any item receiving a low score (1 or 2), qualitative feedback and suggestions for improvement will be collected to ensure the final version is clear and unambiguous

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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