Abstract:

Objective To test the reliability and validity of the COMFORTneo Scale for postoperative pain assessment in Chinese neonates. Methods Through translation，back translation，expert review and pretest，the Chinese version of the COMFORTneo Scale was formed. 52 neonates at the Neonatal Intensive Care Unit in a tertiary general hospital of Guangzhou were recruited from September 2021 to June 2022. Neonates were observed 7 times（preoperatively and 48 hours postoperatively），and recorded for 2 minutes at each encounter including facial expressions and body movements. 2 researchers scored the Chinese COMFORTneo Scale and the Numeric Rating Scale independently while viewing the video clips. 2 weeks later，one of the researchers randomly selected 10 of the neonates’ video clips，viewed and scored them again. The reliability and validity of the scale were evaluated. Results 48 neonates were included，with 4 dropouts. The Chinese COMFORTneo Scale was composed of alertness，calmness/agitation，respiratory response（only in mechanically ventilated neonates），crying（only in spontaneously breathing neonates），body movement，facial tension，and muscle tone（observation only）. In mechanically ventilated and spontaneously breathing neonates，exploratory factor analysis extracted one factor of each，and the factor cumulative variance contribution rates were 57.042% and 66.378%，respectively. The Cronbach’s α coefficients of the scale were 0.819 and 0.885；test-retest reliability was 0.977 and 0.968，respectively. The scores of the Chinese COMFORTneo Scale were significantly positively correlated with the Numeric Rating Scale（r=0.920）. The cut-off value of the Chinese COMFORTneo Scale was 15 and 20 for moderate and severe pain，respectively. Conclusion The Chinese COMFORTneo Scale had good validity and reliability when used to assess postoperative pain in neonates.

Key words: Neonates, Pain, Postoperative, Nursing Assessment, Scale, Reliability, Validity

摘要：

目的 翻译新生儿舒适量表，并检验其在新生儿术后疼痛评估中的信度和效度。 方法 经翻译、回译、专家评议及预测试，形成中文版新生儿舒适量表。选取2021年9月—2022年6月广州市某三级甲等医院NICU收治的52例新生儿作为调查对象，于术前及术后48 h内录制包含新生儿面部表情和肢体动作的视频，每例录制7次，每次2 min。2名研究人员回放视频，独立使用中文版新生儿舒适量表和数字评定量表评估新生儿疼痛程度，其中1名研究人员2周后抽取10例新生儿的视频再次进行疼痛评估，评价量表的信度和效度。 结果 脱落4例，最终纳入48例新生儿。中文版新生儿舒适量表包括警觉性、平静或激惹、呼吸反应（仅用于机械通气新生儿）、哭闹（仅用于自主呼吸新生儿）、肢体活动、面部紧张度和肌张力（仅观察）7个条目。机械通气和自主呼吸新生儿中，探索性因子分析各提取出1个公因子，累计方差贡献率分别为57.042%、66.378%；量表的Cronbach’s α系数分别为0.819、0.885，重测信度分别为0.977、0.968；量表得分与数字评定量表得分呈显著正相关（r=0.920）；量表评估中度和重度疼痛的临界值分别为15、20分。 结论 在新生儿术后疼痛评估中，中文版新生儿舒适量表具有良好的信度和效度。

关键词: 新生儿, 疼痛, 手术后, 护理评估, 量表, 信度, 效度