Psychological benefits and potential pathogen transmission in hospitalized pediatric oncology patients receiving therapy dog visits: a randomized controlled trial

接受治疗犬就诊的住院儿科肿瘤患者的心理益处和潜在病原体传播：一项随机对照试验

• 批准号: 9322093
• 负责人: Jessica Chubak
• 金额: $ 21.07万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9322093
• 关键词: Adverse event; Alaska; Americas; Animals; Anxiety; Biometry; Cancer Patient; Canis familiaris; Caring; Child; Child Psychology; Clinical Trials; Controlled Study; Data; Distress; Emotional; Ensure; Epidemiology; Evidence based program; Future; Goals; Hand; Hand functions; Happiness; Health; Healthcare; Hospitalized Child; Hospitals; Idaho; Immune system; Infection; Infection prevention; Inpatients; Intervention; Knowledge; Length of Stay; Malignant Childhood Neoplasm; Malignant Neoplasms; Measures; Medical; Medical center; Mental Health; Methods; Microbiology; Montana; National Institute of Child Health and Human Development; Nosocomial Infections; Outcome; Pacific Northwest; Pain; Patient Outcomes Assessments; Patient risk; Patients; Pediatric Hospitals; Pediatric Oncology; Pilot Projects; Population; Populations at Risk; Prospective Studies; Provider; Publishing; Randomized; Randomized Controlled Trials; Research; Research Activity; Risk; Safety; Societies; Standardization; Stress; Surveys; Testing; Therapeutic Intervention; United States; Veterinary Medicine; Visit; Washington; Work; aged; arm; cancer care; clinical practice; coping; design; effective intervention; efficacy study; evidence base; experience; high risk; improved; instrument; microbial; named group; pathogen; primary outcome; programs; prospective; psychologic; psychosocial; satisfaction; secondary outcome; transmission process; treatment as usual

PROJECT SUMMARY Strategies to improve the psychological health of children with cancer are greatly needed. Pediatric oncology patients are a special population because of their often long and frequent hospital stays and because of their compromised immune systems. Pilot data suggest that therapy dog visits can reduce distress in this population. However, concerns about risk of infection are barriers to implementing animal-assisted activities (AAA) programs in pediatric oncology settings. No efficacy studies, let alone rigorous randomized controlled trials, have been published on AAA for pediatric oncology inpatients. And no prospective studies have measured pathogen transmission associated with AAA in any setting. The proposed study will rigorously test whether therapy dog visits reduce distress, lower treatment-related anxiety, increase happiness, and improve satisfaction with hospital care in hospitalized children with cancer (Aim 1). This study will also contribute to knowledge about the safety of therapy dog visits by determining whether these visits increase microbial levels on patients’ hands (Aim 2), which could increase infection risk. A randomized controlled trial of 40 pediatric oncology patients (aged 6-17) will be conducted at Seattle Children’s Hospital, a large, quaternary-care medical center in the Pacific Northwest that serves Washington, Alaska, Montana, and Idaho. Patients will be randomized 1:1 to usual care or to the intervention, which will consist of twice-weekly therapy dog visits. Distress and other psychological health outcomes after each visit, at discharge, and 2 weeks post discharge will be assessed using patient surveys with standardized, validated instruments. Microbial levels will be assessed by culturing patients’ hands using a standard method. Rigorous methods for clinical trials (e.g., allocation concealment, intent-to-treat analyses) will be employed to ensure high quality results. This study will provide hospitals and care providers with information needed to make evidence-based decisions about offering therapy dog visits to pediatric oncology inpatients. If this study demonstrates therapy dog visits can improve the psychological health of pediatric oncology inpatients without transmitting pathogens, evidence-based programs could improve cancer-care experiences for children nationwide. If therapy dog visits improve psychological health but transmit pathogens that remain on children’s hands, further research can evaluate strategies to reduce this risk. If therapy dog visits do not reduce distress for pediatric oncology inpatients, future studies can adapt and tailor “active ingredients” from other AAA interventions in other settings. Thus, findings from the proposed study are expected to have a large impact on clinical practice and future AAA research. The proposed study directly responds to the National Institute of Child Health and Human Development’s goal of stimulating rigorous research on animal-assisted interventions for special populations.

项目概要 非常需要改善癌症儿童心理健康的策略。 患者是一个特殊人群，因为他们通常住院时间长且频繁，而且他们的病情也很严重。 试点数据表明，治疗犬的拜访可以减少这种痛苦。 然而，对感染风险的担忧是实施动物辅助活动的障碍。 (AAA) 儿科肿瘤学项目没有疗效研究，更不用说严格的随机对照。 AAA 上已发表针对儿科肿瘤住院患者的试验，但尚无前瞻性研究。 所提议的研究将在任何环境下测量与 AAA 相关的病原体传播。 治疗犬的来访是否可以减轻痛苦、降低与治疗相关的焦虑、增加幸福感并改善 癌症住院儿童对医院护理的满意度（目标 1）。 通过确定治疗犬拜访是否会增加微生物水平来了解治疗犬拜访的安全性 一项针对 40 名儿科患者的随机对照试验。 肿瘤患者（6-17 岁）将在西雅图儿童医院接受治疗，该医院是一家大型四级护理机构 太平洋西北地区的医疗中心将为华盛顿、阿拉斯加州、蒙大拿州和爱达荷州的患者提供服务。 按 1:1 的比例随机分配至常规护理或干预组，其中包括每周两次的治疗犬探访。 每次就诊后、出院时和出院后 2 周后的痛苦和其他心理健康结果 将使用标准化、经过验证的仪器进行患者调查来评估。 使用严格的临床试验方法（例如， 本研究将采用分配隐藏、意向治疗分析等方法来确保高质量的结果。 为医院和护理提供者提供做出基于证据的医疗服务决策所需的信息 如果这项研究表明治疗犬探视可以改善儿科肿瘤住院患者的情况。 不传播病原体的儿科肿瘤住院患者的心理健康，基于证据 如果治疗犬的探访有所改善，这些计划可以改善全国儿童的癌症护理体验。 心理健康，但会传播儿童手上残留的病原体，进一步研究可以评估 如果治疗犬的来访不能减少儿科肿瘤住院患者的痛苦， 未来的研究可以适应和定制其他环境中其他 AAA 干预措施的“活性成分”。 拟议研究的结果预计将对临床实践和未来 AAA 产生重大影响 拟议的研究直接响应国家儿童健康和人类研究所。 发展的目标是刺激针对特殊人群的动物辅助干预措施的严格研究。