Parent/Health Care Provider Behaviors & Child's Anxiety

描述（由申请人提供）：美国每年约有400万儿童接受手术，其中高达65%的儿童在手术前经历了严重的焦虑和痛苦。术前高度焦虑不仅会造成情感创伤，还会导致术后不良结局，如疼痛和镇痛需求增加、延迟出院和适应不良的行为变化。在耶鲁大学完成的一项研究中，我们的小组确定了医疗保健提供者和父母的特定行为，这些行为可以很容易地融入忙碌的实践环境，并对儿童手术前的痛苦和应对行为产生积极影响。基于这些数据，我们开发了一种针对围手术期压力的供应商定制干预（P-TIPS），旨在通过改变成人的行为来减少儿童手术前的焦虑和痛苦。在加州洛杉矶大学和加州尔湾大学进行的一项试点试验成功地证明了P-TIPS的可行性和初步疗效，并检查了剂量有效性。拟议的四个加州儿童医院的随机分组试验，每个医院共有约20名麻醉和护理卫生保健提供者（HCP），将检查P-TIPS在预防高度焦虑和改善手术儿童恢复过程中的有效性。将收集儿童术前焦虑和术后恢复的客观指标。该研究的主要目的是确定P-TIPS是否比标准护理更有效地预防接受麻醉和手术的儿童的术前焦虑。本研究的次要目的是：1。研究P-TIPS对术后疼痛、恢复期住院时间、恶心呕吐、苏醒期谵妄和适应不良行为改变等手术恢复参数的影响。确定是否使用P-TIPS的结果在更高的满意度和更低的焦虑得分的父母和3。确定与对照组相比，P-TIPS组中的HCP是否表现出更多的期望行为和更少的非期望行为。我们希望这个项目在本质上是变革性的，因为在过去，所有术前焦虑的治疗方式都集中在一个单独的孩子-父母二人组上。相比之下，这种干预措施的目标是医疗保健提供者，他们可能在其职业生涯中治疗数千对儿童-父母。一旦测试有效性，P-TIPS将在全国各地的医院实施。 公共卫生相关性：拟议的研究将检查修改医疗保健提供者和父母在手术环境中的行为的有效性。如果我们发现这种干预措施能有效降低手术患儿的术前焦虑和改善术后恢复，那么它就可以作为美国的标准治疗纳入治疗计划。与美国麻醉医师协会、美国麻醉学委员会和儿科麻醉学会的初步讨论表明，这些组织愿意将P-TIPS纳入住院医师、奖学金和继续医学教育计划。

DESCRIPTION (provided by applicant): About 4 million children undergo surgery in the US each year and up to 65% of these children experience significant anxiety and distress before surgery. Not only is high preoperative anxiety emotionally traumatic, but it also leads to postoperative adverse outcomes such as increased pain and analgesic requirements, delayed hospital discharge, and maladaptive behavioral changes. In a study completed at Yale, our group identified specific behaviors by health care providers and parents that can easily be incorporated into a busy practice environment and positively impact children's distress and coping behaviors prior to surgery. Based on these data we developed a Provider Tailored Intervention for Perioperative Stress (P-TIPS) that is aimed at reducing anxiety and distress in children prior to surgery by modifying adults' behavior. A pilot trial conducted at University of California Los Angeles and University of California Irvine successfully demonstrated the feasibility and initial efficacy of P-TIPS and examined dose-effectiveness. The proposed clustered randomized trial of four California children's hospitals, each with a total of approximately 20 anesthesia and nursing health care providers (HCP) will examine the effectiveness of P-TIPS in preventing high anxiety and improving the recovery process in children undergoing surgery. Objective measures of children's preoperative anxiety and postoperative recovery will be collected. The primary aim of the study is to determine if P-TIPS is more effective than standard care for preventing high preoperative anxiety among children undergoing anesthesia and surgery. Secondary aims of the study are to: 1. Examine the impact of P-TIPS on surgical recovery parameters such as postoperative pain, recovery room stay, nausea and vomiting, emergence delirium and maladaptive behavioral changes; 2. Determine if the use of P-TIPS results in higher satisfaction and lower anxiety scores in parents and 3. Determine if HCP in the P-TIPS group display more desired behaviors and less undesired behaviors as compared to the control group. We expect this project to be transformative in nature as in the past all treatment modalities for preoperative anxiety have focused on an individual child- parent dyad. In contrast, this intervention is aimed at health care providers who are likely to treat thousands of child-parent dyads in their career. Once tested for effectiveness P-TIPS will be implemented in hospitals across the country. PUBLIC HEALTH RELEVANCE: The proposed study will examine the efficacy of modifying health care providers and parents' behavior in surgical settings. If we find that this intervention is effective in decreasing preoperative anxiety and improving the postoperative recovery in children undergoing surgery, then it can be incorporated into a treatment plan as the standard of care in the US. Preliminary discussions with the American Society of Anesthesiologists, the American Board of Anesthesiology and the Society of Pediatric Anesthesia have indicated the willingness of these organizations to include P-TIPS in residency, fellowship and CME programs.