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

NCT07463170 | Not Yet Recruiting

• 1 other identifier: APHP251490
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Keywords

Pain; Newborns; Pain Assessment Scales; COMFORTNeo; Cross-cultural Adaptation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Multidisciplinary expert committee

Other: Expert committee

Professionals

Other: Pre test

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).

Multidisciplinary expert committee

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.

Professionals

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort of healthcare professionals working in neonatal care units.

You may qualify if:

• 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).

You may not qualify if:

• \- Refusal to participate, indicated by non-response to the questionnaire.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Centre d'Evaluation et de Traitement de la Douleur, Médecine Palliative (CETD-MP)

Paris, Île-de-France Region, 75015, France

Location

MeSH Terms

Conditions

Pain

Interventions

Evaluation Studies as Topic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Louise CHARRIE

CONTACT

01 44 38 18 65; louise.charrie@aphp.fr

Aline DECHANET

CONTACT

01 71 19 61 69; aline.dechanet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 11, 2026
• Study Start: April 1, 2026
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)