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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Other: Expert committee; Other: Pre test

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

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Aline DECHANET; Phone Number: +33 01 71 19 61 69; Email: aline.dechanet@aphp.fr
• Study Contact Backup: Name: Louise CHARRIE; Phone Number: +33 01 44 38 18 65; Email: louise.charrie@aphp.fr

Study Locations

• France
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75015
      • Centre d'Evaluation et de Traitement de la Douleur, Médecine Palliative (CETD-MP)
      • Contact: Louise CHARRIE; Phone Number: +33 01.44.38.18.65; Email: louise.charrie@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cohort of healthcare professionals working in neonatal care units.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Professionals	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.
Multidisciplinary expert committee	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Content Validity and Linguistic Equivalence of the French COMFORTneo Scale	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.	Within 1 month after the completion of the expert committee review and statistical CVI calculation.
Comprehensibility Assessment (Pre-testing phase)	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	Within 3 months after the completion of the pretesting phase at all clinical site

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 11, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Newborns; Pain Assessment Scales; COMFORTNeo; Cross-cultural Adaptation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Health Care Quality, Access, and Evaluation; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Evaluation Studies as Topic
• Other Study ID Numbers: APHP251490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No