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。高度的术前焦虑不仅会造成情绪上的创伤，而且还会导致术后的不良后果，如增加疼痛和止痛药需求，延迟出院，以及不适应行为的改变。在耶鲁大学完成的一项研究中，我们的团队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纳入繁忙的练习环境，并在手术前对儿童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提供者定制干预(P-TIPS)，旨在通过改变成年人的行为来减少儿童手术前的焦虑和痛苦。在加州大学洛杉矶分校和加州大学欧文分校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-效果。这项拟议的针对4家加州儿童医院的随机分组试验，每家医院总共有大约20名麻醉和护理保健提供者(HCP)，将检验P-TIPS在预防高度焦虑和改善接受手术的儿童的康复过程方面的有效性。收集儿童术前焦虑和术后康复的客观测量。这项研究的主要目的是确定P-TIPS是否比标准护理在预防麻醉和手术儿童的术前高度焦虑方面更有效。本研究的次要目的是：1.检查P-TIPS对手术后疼痛、恢复室停留时间、恶心和呕吐、出现精神错乱和适应不良行为改变等手术恢复参数的影响；2.确定P-TIPS的使用是否导致父母更高的满意度和更低的焦虑得分；3.确定与对照组相比，P-TIPS组的HCP是否表现出更多的期望行为和更少的不良行为。我们期望这个项目在本质上具有变革性，因为在过去，所有术前焦虑的治疗方式都集中在个别的孩子-父母二元组上。相比之下，这种干预针对的是那些在职业生涯中可能治疗数以千计的亲子双方的卫生保健提供者。一旦测试有效，P-TIPS将在全国各地的医院实施。 公共卫生相关性：这项拟议的研究将检查改变医疗保健提供者和父母在手术环境中行为的效果。如果我们发现这种干预措施在降低接受手术的儿童的术前焦虑和改善术后恢复方面是有效的，那么它可以被纳入治疗计划，作为美国的护理标准。与美国麻醉学家协会、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.