BACKGROUND Preoperative anxiety is common and most patients experiencing preoperative anxiety would welcome support to cope with their anxiety. Studies examining the effectiveness of information to reduce anxiety have been inconsistent. In addition, it is unclear whether results reported to be statistically significant are also clinically relevant. This study's primary objective was to test the hypothesis that a personalized and information-based intervention would reduce anesthesia-related anxiety. METHODS In this single-center, prospective, randomized, controlled trial, 122 adults awaiting elective surgery under general anesthesia were randomized (1:1) to receive a personalized and information-based intervention in addition to standard preanesthetic consultation (intervention group) or standard preanesthetic consultation (control group) the day before surgery. Anxiety was assessed at two time points before and at four time points after randomization until induction of anesthesia to state their anxiety level using the Amsterdam Preoperative Anxiety and Information Scale (two items each for anesthesia- and surgery-related anxiety, each item's score range: 1-5). Constrained linear mixed models were used to analyze the intervention effects. Patients' subjective changes in anxiety (reduced vs. not reduced) and associated numeric scores were used to determine the minimal clinically important difference. RESULTS The intervention led to reduced anesthesia- and surgery-related anxiety in the intervention group compared to the control group after randomization (indicated by significant two-way interactions for anesthesia-related anxiety (F(5, 96.291) = 7.449, p<.001) and surgery-related anxiety (F(5, 112.486) = 5.466, p<.001)). The minimal clinically important difference in Amsterdam Preoperative Anxiety and Information Scale anxiety scores was 1.03 and 1.13 points for anesthesia- and surgery-related anxiety, respectively. CONCLUSIONS A personalized and information-based intervention can reduce anesthesia- and surgery-related anxiety to a statistically significant and clinically relevant degree. Future studies should include an active control group to evaluate this intervention's specific effects which may be helpful only in patients seeking anxiety-reducing interventions.

中文翻译：

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个性化干预对术前焦虑的影响和焦虑水平最小临床重要差异的确定 - 一项随机临床试验。


背景 术前焦虑很常见，大多数经历术前焦虑的患者都希望得到支持来应对他们的焦虑。检查信息对减轻焦虑的有效性的研究一直不一致。此外，目前尚不清楚报告具有统计学意义的结果是否也具有临床相关性。本研究的主要目的是检验个性化和基于信息的干预会减少与麻醉相关的焦虑的假设。方法 在这项单中心、前瞻性、随机、对照试验中，122 名在全身麻醉下等待择期手术的成年人被随机分配 （1：1） 接受个性化和基于信息的干预，除了标准麻醉前咨询 （干预组） 或标准麻醉前咨询 （对照组） 手术前一天。在随机分组前的两个时间点和随机分组后的四个时间点评估焦虑，直至麻醉诱导，以使用阿姆斯特丹术前焦虑和信息量表（麻醉和手术相关焦虑各两个项目，每个项目的评分范围：1-5）说明他们的焦虑水平。采用约束线性混合模型分析干预效果。患者焦虑的主观变化 （减少 vs. 未减少） 和相关数字评分用于确定最小的临床重要差异。结果与对照组相比，随机分组后干预组的麻醉和手术相关焦虑减少（表现为麻醉相关焦虑 （F（5， 96.291） = 7.449， p<.001） 和手术相关焦虑 （F（5， 112.486） = 5.466， p<.001））。 阿姆斯特丹术前焦虑和信息量表焦虑评分的最小临床重要差异分别为麻醉和手术相关焦虑 1.03 分和 1.13 分。结论 个性化和基于信息的干预可以将麻醉和手术相关的焦虑降低到具有统计学意义和临床相关性的程度。未来的研究应包括一个积极对照组来评估这种干预的具体效果，这可能只对寻求减轻焦虑干预的患者有用。