跳至主要内容
临床试验/NCT07463170
NCT07463170招募中不适用

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

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年6月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Content Validity and Linguistic Equivalence of the French COMFORTneo Scale

研究概览

简要总结

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.

详细描述

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]).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

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

研究组 & 干预措施

Multidisciplinary expert committee

干预措施: Expert committee (Other)

Professionals

干预措施: Pre test (Other)

结局指标

主要结局

Content Validity and Linguistic Equivalence of the French COMFORTneo Scale

时间窗: 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)

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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