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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT07463170
Status
Not Yet Recruiting

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Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Expert committee — OTHER
    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 — OTHER
    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 Details

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 Dates

First listed
Mar 11, 2026
Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Multidisciplinary expert committee
  • Arm: Professionals

Primary Outcome Measure

Content Validity and Linguistic Equivalence of the French COMFORTneo Scale [ Time Frame: Within 1 month after the completion of the expert committee review and statistical CVI calculation. ]

Central Contacts

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