NCT07463170

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

To treat pain, it is first necessary to recognize and assess it. Pain assessment is the responsibility of all healthcare professionals. It is framed both by patients' rights and by healthcare professionals' duties, as defined by their codes of ethics and professional competency regulations. The identification and measurement of pain through an "assessment adapted to the patient's clinical condition" were notably specified in the latest French healthcare facility certification standards as a mandatory criterion. In neonatal care units, the patient population is highly heterogeneous, and levels of care vary depending on the hospitalization setting (Maternity, Mother-Baby Unit, Neonatology, Intermediate Care, or NICU). A newborn hospitalized in a neonatal unit is exposed to an average of 16 painful procedures per day of hospitalization. The long-term negative impact of pain on these newborns-on their responses to re-exposure to painful procedures, on their development, and on their future health - is now widely described in the literature. There is no formal objective measure of pain; therefore, pain can only be approached through subjective assessment. Pain assessment in young children, particularly in newborns and infants who cannot express themselves verbally, is even more complex and must distinguish between pain-related manifestations and those related to other sensations or needs. Several research studies have contributed to a better understanding of pain manifestations in this population and have supported the development of pain assessment scales. By "measuring" certain behavioral, physiological, or contextual indicators, these scales aim to estimate the pain experienced by the child. This mode of assessment is referred to as observational assessment (proxy assessment), meaning that the evaluation is performed by someone other than the person experiencing pain. Several pain assessment scales have been extensively studied, and their psychometric properties as well as their clinical relevance have been validated through high-quality studies. Numerous tools are therefore currently available for use in young children. However, these instruments are sometimes validated for very specific populations, and there is no international or national consensus regarding the choice of tool, which is often left to the discretion of each clinical unit. For example, in a neonatal unit in mainland France, it is currently possible to find up to three different pain assessment scales used to evaluate all hospitalized patients within the same unit, depending on gestational age, level of ventilation, and level of sedation (EDIN, DAN, EVENDOL, and COMFORT-B are the pain scales validated for neonatology in France by the French National Authority for Health \[HAS\]). The primary objectives of pain assessment are to identify pain, characterize it, and monitor its evolution, particularly after the initiation of analgesic treatment, as well as to establish a common language among healthcare professionals. It therefore appears important and relevant, in order to minimize measurement bias, that pain assessment relies on a single tool, especially within the same clinical unit. This study is a prospective observational study for the translation and cross-cultural adaptation of the COMFORTneo neonatal pain assessment scale, involving a multidisciplinary expert committee of medical, paramedical, and translation professional

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	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).
OTHER	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: France