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.

项目摘要 非常需要改善癌症儿童心理健康的策略。儿科肿瘤 病人是一个特殊的群体，因为他们往往长期和频繁的住院，因为他们的 免疫系统受损试点数据表明，治疗犬的访问可以减少这种痛苦， 人口然而，对感染风险的担忧是实施动物辅助活动的障碍 (AAA)在儿科肿瘤学设置的程序。没有疗效研究，更不用说严格的随机对照研究了。 试验，已发表在AAA上的儿科肿瘤住院患者。没有前瞻性研究 在任何情况下，测量与AAA相关的病原体传播。这项研究将严格测试 治疗狗的访问是否减少了痛苦，降低了治疗相关的焦虑，增加了幸福感， 癌症住院儿童对医院护理的满意度（目标1）。这项研究还将有助于 通过确定治疗犬访视是否会增加微生物水平，了解治疗犬访视的安全性 在患者手上（目标2），这可能会增加感染风险。一项40名儿童的随机对照试验 肿瘤患者（6-17岁）将在西雅图儿童医院进行，这是一家大型的四级护理中心。 位于太平洋西北部的医疗中心，服务于华盛顿、阿拉斯加、蒙大拿和爱达荷州。患者将 以1：1的比例随机分配至常规护理组或干预组，其中包括每周两次的治疗犬访视。 每次访视后、出院时和出院后2周的痛苦和其他心理健康结局 将使用标准化、经验证的工具进行患者调查。微生物水平将是 用标准方法培养病人的手来评估。严格的临床试验方法（例如， 分配隐藏，意向治疗分析），以确保高质量的结果。本研究将 为医院和护理提供者提供所需的信息，以做出基于证据的决策， 治疗犬访问儿科肿瘤住院患者。如果这项研究表明治疗狗访问可以改善 儿科肿瘤住院患者心理健康无传播病原体，循证 这些项目可以改善全国儿童的癌症护理体验。如果治疗狗的访问改善 心理健康，但传播留在儿童手上的病原体，进一步的研究可以评估 降低这种风险的策略。如果治疗犬的访问不能减少儿科肿瘤住院患者的痛苦， 未来的研究可以从其他AAA干预措施中调整和调整“活性成分”。因此，在本发明中， 预计拟议研究的结果将对临床实践和未来AAA产生重大影响 research.这项研究直接响应了国家儿童健康和人类研究所的建议。 发展的目标是激励对特殊人群的动物辅助干预进行严格的研究。