数据来源： Medline, ISI of Knowledge, Cochrane Central Register of Controlled Trials, Science Direct, Scopus, American Psychological Association PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and Latin American and Caribbean Health Sciences Literature
数据提取和综合： 两名研究人员独立筛选研究，提取数据并评估偏倚风险。两名研究者分别使用Jadad量表、经修订的Cochrane偏倚风险工具进行随机对照试验（RoB 2）和非随机对照试验研究偏倚风险（ROBINS-I）和方法学评估。
结果： 24项研究（n = 1612）符合数据提取和分析的纳入标准。多数研究是随机对照试验（n = 13）。焦虑是最经常分析的症状（n = 13），其次是疼痛（n = 9）、心理和情绪反应以及感知的幸福感（n = 4）、压力（n = 4）、癌症相关的疲劳（n = 3）以及哭泣（n = 2）。五项研究使用生物标志物（主要是皮质醇）来评估小丑干预后的压力或疲劳结果。大多数随机对照试验（n = 11；85％）被评为显示出一定的偏倚风险，而两项试验被认为具有较高的偏倚风险。根据ROBINS-I工具，大多数非随机对照试验（n = 6; 55％）的偏倚风险中等。研究表明，在有医疗小丑的情况下，儿童和青少年无论有无父母陪伴，在一系列医疗过程中的焦虑情绪均明显降低，并且心理适应性得到改善（P <0.05）。评估慢性病的三项研究显示，小丑干预组的压力，疲劳，疼痛和痛苦显著减少（P <0.05）。
Objective: To evaluate evidence from randomised controlled trials and non-randomised controlled trials on the effectiveness of hospital clowns for a range of symptom clusters in children and adolescents admitted to hospital with acute and chronic conditions.
Design: Systematic review of randomised and non-randomised controlled trials.
Data sources: Medline, ISI of Knowledge, Cochrane Central Register of Controlled Trials, Science Direct, Scopus, American Psychological Association PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and Latin American and Caribbean Health Sciences Literature.
Study selection: Randomised and non-randomised controlled trials were peer reviewed using the following eligibility criteria: children and adolescents who were admitted to hospital for acute conditions or chronic disorders, studies comparing use of hospital clowns with standard care, and studies evaluating the effect of hospital clowns on symptom management of inpatient children and adolescents as a primary outcome.
Data extraction and synthesis: Two investigators independently screened studies, extracted data, and appraised the risk of bias. Methodological appraisal was assessed by two investigators independently using the Jadad scale, the revised Cochrane risk-of-bias tool for randomised controlled trials (RoB 2), and the risk of bias in non-randomised studies (ROBINS-I) tool for non-randomised controlled trials.
Results: 24 studies (n=1612) met the inclusion criteria for data extraction and analysis. Most studies were randomised controlled trials (n=13). Anxiety was the most frequently analysed symptom (n=13), followed by pain (n=9), psychological and emotional responses and perceived wellbeing (n=4), stress (n=4), cancer related fatigue (n=3), and crying (n=2). Five studies used biomarkers, mainly cortisol, to assess stress or fatigue outcome following hospital clowns. Most of the randomised controlled trials (n=11; 85%) were rated as showing some concerns, and two trials were rated with a high risk of bias. Most non-randomised controlled trials (n=6; 55%) were rated with a moderate risk of bias according to ROBINS-I tool. Studies showed that children and adolescents who were in the presence of hospital clowns, either with or without a parent present, reported significantly less anxiety during a range of medical procedures, as well as improved psychological adjustment (P<0.05). Three studies that evaluated chronic conditions showed favourable results for the intervention of hospital clowns with significant reduction in stress, fatigue, pain, and distress (P<0.05).
Conclusions: These findings suggest that the presence of hospital clowns during medical procedures, induction of anaesthesia in the preoperative room, and as part of routine care for chronic conditions might be a beneficial strategy to manage some symptom clusters. Furthermore, hospital clowns might help improve psychological wellbeing in admitted children and adolescents with acute and chronic disorders, compared with those who received only standard care.
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