Kawabe-Ishibashi Chika, Funahashi Keiichi, Amano Kanae, Takeuchi Ayako, Kojima Taiki, Amano Kojiro, Suzuki Yasuko, Aoyama Kazuyoshi, Kuratani Norifumi
Department of Anesthesia, Saitama Children's Medical Center, Saitama, Japan.
Department of Anesthesiology and Pain Medicine, Juntendo University School of Medicine, Tokyo, Japan.
Paediatr Anaesth. 2025 Aug 2. doi: 10.1111/pan.70020.
Preoperative anxiety in children can lead to enduring psychological effects, highlighting the need for validated assessment tools. Although the modified Yale Preoperative Anxiety Scale is internationally recognized for evaluating pediatric anxiety, no validated Japanese version is available.
We aimed to develop a Japanese version of the modified Yale Preoperative Anxiety Scale per internationally recognized translation guidelines, and conduct a pilot study to assess its feasibility, psychometric properties, and sample size requirements for future formal psychometric evaluations.
After obtaining approval from the original authors, a translation team followed the International Society for Pharmacoeconomics and Outcomes Research Task Force Guidelines, including forward and back translations, cultural adaptation, and cognitive debriefing. This pilot study involved 15 children (aged 5-12 years) undergoing elective surgery under general anesthesia. Reliability (internal consistency, inter-rater, and intra-rater) and validity (concurrent validity against the State-Trait Anxiety Inventory for Children) were assessed. The Walter's formula was used to calculate the sample size needed for formal reliability studies.
Following a successful translation and cultural adaptation process, the Japanese version of the scale demonstrated high internal consistency (Cronbach's α = 0.954) and moderate-to-very-good inter-rater reliability (weighted Kappa = 0.42-0.92). Intra-rater reliability was excellent (intraclass correlation coefficient = 0.86-0.97). However, correlations with the STAIC-State were poor (r = -0.20 to -0.01), likely reflecting cultural norms of emotional restraint and differences in assessment timings. Sample size calculations indicated that 99 patients would be required for future reliability studies.
The Japanese version of the scale was successfully developed, and pilot findings indicated its feasibility in Japanese clinical settings; a large multicenter validation is now required to confirm its psychometric properties. Incorporating the developed version of the scale into clinical practice may facilitate earlier identification and management of pediatric preoperative anxiety in Japan.
UMIN Clinical Trials Registry: UMIN000047537.
儿童术前焦虑可导致持久的心理影响，这凸显了对经过验证的评估工具的需求。尽管改良耶鲁术前焦虑量表在国际上被认可用于评估儿科焦虑，但尚无经过验证的日语版本。
我们旨在按照国际认可的翻译指南开发改良耶鲁术前焦虑量表的日语版本，并进行一项试点研究，以评估其可行性、心理测量特性以及未来正式心理测量评估所需的样本量。
在获得原作者批准后，一个翻译团队遵循国际药物经济学与结果研究协会工作组指南，包括正向和反向翻译、文化调适以及认知反馈。这项试点研究纳入了15名接受全身麻醉下择期手术的儿童（年龄5 - 12岁）。评估了信度（内部一致性、评分者间信度和评分者内信度）和效度（与儿童状态 - 特质焦虑量表的同时效度）。使用沃尔特公式计算正式信度研究所需的样本量。
经过成功的翻译和文化调适过程，该量表的日语版本显示出高内部一致性（克朗巴哈α系数 = 0.954）以及中等至非常好的评分者间信度（加权卡帕系数 = 0.42 - 0.92）。评分者内信度极佳（组内相关系数 = 0.86 - 0.97）。然而，与儿童状态 - 特质焦虑量表状态分量表的相关性较差（r = -0.20至 -0.01），这可能反映了情绪克制的文化规范以及评估时间的差异。样本量计算表明未来的信度研究需要99名患者。
该量表的日语版本已成功开发，试点结果表明其在日本临床环境中的可行性；现在需要进行大规模多中心验证以确认其心理测量特性。将开发的量表版本纳入临床实践可能有助于在日本更早地识别和管理儿科术前焦虑。
UMIN临床试验注册中心：UMIN000047537。
