Effectiveness of clown intervention for pain relief in children: A systematic review and meta-analysis.

BACKGROUND: Pain is common in children receiving medical procedures, and there is a lack of adequate awareness and management. In addition, children who undergo medical procedures involving pain may also experience stress, crying and prolonged hospitalisation. Clown intervention is a promising nonpharmacological intervention. However, studies on the effectiveness of clown intervention in pain management have reported conflicting findings. OBJECTIVE: To evaluate the effectiveness of clown intervention in relieving pain in children, as well as its effects on cortisol levels, crying duration and length of hospital stay. DESIGN: Systematic review and meta-analysis of randomised controlled studies. DATA SOURCES: PubMed, Web of Science (SCI), Embase, PsycINFO, the Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), Weipu (VIP), Wanfang Data and SinoMed were systematically searched from inception date to December 31, 2020. REVIEW METHODS: Two reviewers independently used the Cochrane risk of bias tool to assess the risk of bias of the included studies. Meta-analysis was conducted when data were available, otherwise, a narrative description was provided. Data were analysed using Review Manager 5.3. The review process is reported according to PRISMA. RESULTS: Nine studies including 852 children met the inclusion criteria. The results showed that compared with standard care, clown intervention was beneficial for relieving pain. Further subgroup analysis showed that it was more effective with children aged 2-7 years. The duration of crying after the procedure and the length of stay were shortened, but there was no significant difference in cortisol levels. CONCLUSION: Clown intervention may be a promising way to relieve acute pain in children, especially those aged 2-7 years. It also seems to shorten the duration of crying and the length of hospital stays, but the effect on cortisol levels is still uncertain. More high-quality randomised controlled trials are needed to confirm these results and take into account different age groups, cultural backgrounds and specific populations.

Systematic review protocol examining the effectiveness of hospital clowns for symptom cluster management in paediatrics.

INTRODUCTION: Clown intervention may playing an important complementary role in paediatric care and recovery. However, data on its utility for symptom cluster management of hospitalised children and adolescents in acute and chronic disorders are yet to be critically evaluated. As clinicians strive to minimise the psychological burden during hospitalisation, it is important that they are aware of the scientific evidences available regarding clown intervention for symptom management. We aim to provide quality evidence for the effectiveness of clown intervention on symptom cluster management in paediatric inpatients, both in acute and chronic conditions. METHODS AND ANALYSIS: A systematic review of randomised controlled trials (RCTs) and non-randomised controlled trials (NRCTs) will be conducted. MEDLINE, Web of Science, Cochrane Library, Science Direct, PsycINFO, CINAHL, LILACS and SciELO databases will be searched from January 2000 to December 2018. Primary outcomes will include measures related with the effect of clown intervention on symptom cluster of paediatric inpatients (anxiety, depression, pain, fatigue, stress and psychological, emotional responses and perceived well-being). Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and the methodological appraisal of the studies will be assessed by the Jadad Scale as well as Cochrane Risk-of-Bias Tool for RCTs, and Risk-of-Bias In Non-Randomized Studies Tool for NRCTs. A narrative synthesis will be conducted for all included studies. Also, if sufficient data are available, a meta-analysis will be conducted. The effect sizes will be generated using Hedges' g score for both fixed and random effect models. I 2 statistics will be used to assess heterogeneity and identify their potential sources. ETHICS AND DISSEMINATION: As it will be a systematic review, without human beings involvement, there will be no requirement for ethical approval. Findings will be disseminated widely through peer-reviewed publication and in various media, for example, conferences, congresses or symposia. TRIAL REGISTRATION NUMBER: CRD42018107099.

Confirmatory factor analysis of the Questionnaire on the Health Staff's Perceptions Regarding Doutores da Alegria's Interventions.

A confirmatory analysis was performed to validate the Questionnaire on the Health Staff's Perceptions Regarding Doutores da Alegria's Intervention, a 40-item instrument designed to assess pediatric staff's perceptions regarding the effects of Doutores da Alegria, a Brazilian hospital clowning professional organization. Eight dimensions were evaluated: the permanence of Doutores da Alegria's interventions; Doutores da Alegria's intrapersonal and interpersonal effects on their relation to health staff; themselves; staff-children; and staff-family relationships; as well as their effect on staff's cultural development; children's relation to their own disease; and families' attitude regarding their child's condition. In all, 567 health professionals from 13 Brazilian hospitals participated. The instrument's good psychometric features are acknowledged.

The Effect of Clown Intervention on Self-Report and Biomarker Measures of Stress and Fatigue in Pediatric Osteosarcoma Inpatients: A Pilot Study.

BACKGROUND: Pediatric cancer patients experience different psychological processes during hospitalization that may regulate the immune response and affect recovery and response to cancer treatment. In this study, we aimed to examine the feasibility of longitudinal testing of psychophysiological parameters of stress and fatigue in pediatric osteosarcoma patients hospitalized for chemotherapy submitted to clown intervention; and to investigate whether changes in the levels of biomarkers are associated with psychological stress and fatigue levels in these patients after the clown intervention. METHODS: A pretest-posttest quasi-experimental pilot study was conducted at the pediatric oncology inpatient unit in a comprehensive cancer care center in Brazil including children and adolescents with osteosarcoma hospitalized for chemotherapy. Eight saliva samples were collected, comprising 4 at baseline (pre-intervention) and 4 after the clown intervention (+1, +4, +9, and +13 hours post-awakening). Salivary cortisol, α-amylase (sAA), cytokines, and matrix metalloproteinase-9 (MMP-9) levels were determined using high-sensitivity enzyme-linked immunosorbent assay (ELISA) kits. Stress and fatigue were measured by Child Stress Scale-ESI and PedsQL Multidimensional Fatigue Scale respectively. Bivariate association analysis between stress and fatigue scores and biomarker levels were investigated using nonparametric statistics. Effect sizes were calculated for each outcome variable. RESULTS: Six pediatric osteosarcoma patients were enrolled with no missing data. No significant effects sizes were observed for psychophysiological outcomes. Effect sizes ranged from 0.54 (cortisol) to 0 (interleukin-1ß [IL-1ß]). Decreasing overall trends were observed for cortisol levels for all 6 pediatric osteosarcoma patients over time. In addition, a similar pattern of tumor necrosis factor-α (TNF-α) levels over time was found for all 6 patients. Patients with metastatic osteosarcoma showed a linear trend for a decrease in MMP-9 levels between 1 and 9 hours after the clown intervention and restoration to basal levels after 13 hours. CONCLUSIONS: The results of this pilot study suggest that it is feasible longitudinally measure psychophysiological outcomes in the pediatric osteosarcoma inpatients for chemotherapy. Clown intervention merits further study as a way to reduce stress as well as fatigue, since that the stress and cytokines measurements are feasible based on our work.

Effectiveness of pre-operative clown intervention on psychological distress: A systematic review and meta-analysis.

AIM: This study aims to provide an overview of the current knowledge available on the effectiveness of pre-operative clown intervention on psychological distress in children and parents. METHODS: PubMed, MEDLINE, Embase and PsycINFO databases were searched to identify relevant studies. Systematic review procedures were followed including a quality assessment. Meta-analysis of suitable studies was conducted. RESULTS: Eight studies were included; six reported that clown intervention reduced children's pre-operative anxiety, while one found that children's pre-operative distress levels were unchanged. Two studies suggested that clown therapy decreased parents' state anxiety, while three others found inconsistent results. No differences were found on parents' trait anxiety score. Meta-analysis of the available data confirmed that clown intervention has a great effect to reduce children's pre-operative distress (six articles, 341 children, Hedges' g = 0.867, 95% confidence intervals: 0.374-1.360, P = 0.001), and also had a small-to-medium effect on reducing parents' state anxiety (five articles, 329 parents, Hedges' g = 0.338, 95% confidence intervals: 0.112-0.564, P = 0.003). CONCLUSIONS: While significant variability existed between studies, the meta-analysis confirmed the effectiveness of pre-operative clown therapy on reducing psychological distress in children and parents. Larger randomised controlled trails and cross-cultural studies should be conducted to investigate the effectiveness of clown therapy in greater detail.

Neuroimmunoendocrine trajectories and the response to stress and fatigue in pediatric cancer patients under chemotherapy submitted to clown intervention / Trajetórias neuroimunoendócrinas e resposta ao estresse e à fadiga em pacientes oncológicos pediátricos em tratamento quimioterápico submetidos à intervenção do palhaço

Cancer and the hospitalization process often have a psychological impact on the children and adolescents, usually leading to intense stress as well as fatigue. This especially applies to children and adolescents who have been submitted to chemotherapy, since it still constitutes a stressful and threatening experience for them and may exacerbate cancer symptom burden clusters, leading to a decrease in their health related quality of life (QoL). In addition, stress associated with cancer development leads to disturbances/disruption in the hypothalamicpituitary-adrenal (HPA) axis and suppresses important neuroimmunoendocrine pathways. Hence, interventions aimed at attenuating the physiological changes related to stress favor the recovery of the immune system and, consequently, induce alterations in neuroimmunoendocrine factors that increase immunological surveillance during cancer treatment. With the increase in cancer rates, it is crucial that healthcare professionals develop effective interventions to support pediatric cancer patients during the hospitalization process in order to relieve the burden of cancer treatment, which may contribute to a better prognosis of the disease. In an attempt to alleviate some of the cancer-related symptoms, pediatric oncology patients can take advantage of non-pharmacological interventions, including clown intervention, which can be a very advantageous approach to reduce unpleasant symptoms in pediatric cancer patients. However, few studies have investigated the molecular mechanisms that mediate health outcomes of clown intervention. The main purpose of this study was to investigate the effects of the clown intervention on psychological stress and cancer-related fatigue (CRF) in pediatric cancer inpatients undergoing chemotherapy. Also, we aimed to investigate whether changes in the levels of biomarkers, including cortisol, ?-amylase (sAA), cytokines, and matrix metalloproteinase-9 (MMP-9) are associated with psychological stress and CRF levels in pediatric osteosarcoma inpatients following clown intervention. A pretestposttest quasi-experimental study was undertaken with pediatric cancer inpatients. Eight nonfasting saliva samples were collected at identical times upon clown intervention, i.e., at baseline (pre-intervention) and post-intervention (+ 1h, + 4h, + 9h, and + 13h post awakening). Salivary cortisol, sAA, cytokines and MMP-9 concentrations were measured using high sensitivity Enzyme-Linked Immuno Sorbent Assay. Sociodemographic and clinical data, and Child Stress Scale-ESI(TM) and PedsQL(TM) Multidimensional Fatigue Scale were applied and the results were compared at baseline and after the clown intervention, and also correlated with biomarker trajectories. Data analysis was performed using nonparametric statistical tests. In comparison with baseline measurements, the overall psychological stress for pediatric cancer inpatients as well as their perception of fatigue improved upon clown intervention (p= 0.003; p= 0.049, respectively). There were no significant correlations between sAA and cortisol for both Areas Under Curve (AUC) at baseline or at post-intervention. Also, clown intervention reduced IL1? and salivary cortisol levels in pediatric osteosarcoma inpatients. Additionally, AUC for IL1? positively correlated with AUC for cortisol as well as with AUC for sAA at postintervention. In contrast, levels of IL-6, TNF-?, IL-12p70, IL-10, TGF-? and MMP-9 did not show significant differences upon clown intervention. Overall, our results suggest that clown intervention is a good non-pharmacological intervention to reduce psychological stress and CRF in pediatric cancer inpatients undergoing chemotherapy

O câncer e o processo de hospitalização comumente cursam com forte impacto psicológico sobre as crianças e adolescentes, gerando estresse e fadiga. Isto aplica-se especialmente, para àqueles sob quimioterapia, pois esta, constitui-se em uma das experiências mais estressantes e ameaçadoras que pode exacerbar os sintomas relacionados ao câncer e levar a uma diminuição da qualidade de vida (QV). O estresse associado ao desenvolvimento do câncer pode causar disrupturas no eixo hipotálamo-hipófise-adrenal, e suprimir importantes vias neuroimunoendócrinas. Assim, intervenções destinadas a atenuar as alterações fisiológicas relacionadas ao estresse podem favorecer a recuperação do sistema imune e induzir alterações neuroimunoendócrinas para potencializar a vigilância imunológica durante o tratamento oncológico. Com o aumento da incidência de câncer, é crucial que os profissionais de saúde desenvolvam intervenções eficazes para o manejo dos sintomas oncológicos, de modo a aliviar a sobrecarga do tratamento nesses pacientes durante o processo de hospitalização, de modo a contribuir para um melhor prognóstico da doença. Ademais, pacientes pediátricos oncológicos podem se beneficiar de intervenções não-farmacológicas, por exemplo, a intervenção dos clowns, para aliviar os sintomas relacionados ao câncer. Contudo, poucos estudos têm investigado os mecanismos moleculares envolvendo a intervenção dos clowns. Nosso objetivo principal foi investigar os efeitos da intervenção dos clowns sobre o estresse psicológico e a fadiga-relacionada ao câncer (FRC) em pacientes pediátricos oncológicos sob quimioterapia. Além disso, nós investigamos se alterações nos níveis de cortisol, ?-amilase (sAA), citocinas e metaloproteinases de matriz (MMP-9) estão associadas com estresse psicológico e com FRC de pacientes pediátricos com osteossarcoma submetidos à intervenção dos clowns. Trata-se de um estudo quase-experimental pré-teste/pós-teste. Foram colhidas oito amostras de saliva em momentos idênticos, isto é, no baseline (pré-intervenção) e no pós-intervenção (+ 1h, + 4h, + 9h e + 13h após o despertar). As concentrações de cortisol salivar, sAA, citocinas e MMP-9 foram mensuradas por ELISA. Dados sociodemográficos e clínicos foram coletados via prontuários médicos, além disso, foram aplicadas a Escala de Estresse Infantil-ESI(TM) e a Escala Multidimensional de Fadiga-PedsQL(TM). Os escores das escalas foram comparados entre o baseline e o pós-intervenção, e também, foram correlacionados com os níveis dos biomarcadores. Para análise dos dados, utilizou-se da estatística descritiva e estatística não paramétrica. Em comparação com as medidas do baseline, observamos que os níveis de estresse psicológico total, bem como os de fadiga geral dos pacientes pediátricos oncológicos, melhoraram significativamente após a intervenção dos clowns ( p= 0.003; p= 0.049, respectivamente). Não houve correlações significativas entre as Áreas sob Curva (AUC) da sAA e do cortisol no baseline e nem no pós-intervenção. Além disso, a intervenção dos clowns reduziu os níveis de IL-1? e de cortisol nos pacientes pediátricos com osteossarcoma. A AUC da IL-1? correlacionou-se positivamente com AUC do cortisol e com a AUC da sAA no pósintervenção. Inversamente, os níveis de IL-6, TNF-?, IL-12p70, IL-10, TGF-? e MMP-9 não mostraram diferenças significativas no pós-intervenção. Em síntese, nossos resultados sugerem que a intervenção dos clowns é uma boa intervenção não-farmacológica para reduzir o estresse psicológico e a FRC em pacientes pediátricos oncológicos sob quimioterapia

Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial.

This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety.

Parental anxiety and stress before pediatric anesthesia: a pilot study on the effectiveness of preoperative clown intervention.

As induction of pediatric anesthesia can elicit anxiety in children and parents alike, this study was aimed at evaluating the effectiveness of clown intervention in decreasing maternal anxiety and stress in the preoperative phase. Before anesthesia induction, 25 children were randomly assigned to clown intervention and 25 to a control group with a routine procedure. In the waiting room and after separation from the child, maternal anxiety and stress were measured. The results showed that after separation, only in the clown group, maternal state anxiety significantly decreased and the tendency to somatization did not increase. Moreover, after clown intervention, older children's mothers significantly reduced the level of perceived stress. As clown intervention can positively influence maternal anxiety and stress in the preoperative period, its promotion in clinical-hospital environments is recommended.