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

Abstract

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-1β [IL-1β]). 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 hospital clowns for symptom management in paediatrics: systematic review of randomised and non-randomised controlled trials

“…49 All the studies were single centre trials, and most included male and female patients (n=23). 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 63 64 65 66 67 68 69 Only one study exclusively included male patients 62 because the study population included children undergoing outpatient penile surgery. Fourteen studies exclusively involved children in hospital (age 2-12), 46 47 48 49 50 52 57 59 60 61 62 63 64 67 and the 10 remaining studies included both children and adolescents in hospital (age 13-18).…”

“…Fourteen studies exclusively involved children in hospital (age 2-12), 46 47 48 49 50 52 57 59 60 61 62 63 64 67 and the 10 remaining studies included both children and adolescents in hospital (age 13-18). 51 53 54 55 56 58 65 66 68 69 The mean sample size among studies was 67.16 (standard deviation 57.22, range 6-306). 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 …”

“…Of 11 non-randomised controlled trials, only one was rated with a low risk of bias in all domains, 66 six 50 59 64 65 68 69 showed moderate risk of bias according to ROBINS-I, and four 49 54 55 63 showed serious risk according to ROBINS-I classification owing to the presence of serious risk of bias in at least one domain (although they were at low or moderate risk of bias for most domains; table 1 ). In general, regarding the risk of bias assessment for non-randomised controlled trials, the main causes of serious overall bias risk according to ROBINS-I were weaknesses in the confounding bias domains, selection of participants, and outcome measurement biases.…”

The Effects of Hospital Clowning on Physical and Emotional States of Pediatric Patients During Chemotherapy Treatment

“…Although this study has not assessed the cost-effectiveness of the HC practice, their intervention may reduce the costs often associated with cancer treatment, by lowering the patient's negative emotions and physical symptoms and increasing their well-being while they undertake the chemotherapy treatment prescribed for their condition. Nevertheless, because the research with HCs is still scarce (Lopes-Júnior et al 2018;Petrangeli et al 2012;Gorfinkle et al 1998), the benefits associated with their work merits further investigation.…”

“…Despite the favorable results of HC's intervention with pediatric populations, less research has been conducted with other procedures such as cancer treatment. To our knowledge, there are only three studies in this area: two reported in conference proceedings (Petrangeli et al 2012;Gorfinkle et al 1998) and one pilot study (Lopes-Júnior et al 2018). Petrangeli et al (2012) indicated that HCs reduced fatigue in patients aged 7-18 years undergoing chemotherapy, whereas Gorfinkle et al (1998) found no effects from HC presence on distress among 3-18 years old patients.…”