Title: The impact of Clown Therapy in a Palliative Care Unit (PCU); a pilot studyBackground: Although several studies on clown therapy have demonstrated benefits for children and the elderly, few studies exist on its impact on quality of life in adult terminal patients.We devised this monocentric, prospective, descriptive pilot study, covering both quantitative and qualitative aspects, to test the hypothesis that “clowning” in the PCU would help to improve the quality of life of patients, and benefit those accompanying them and their carers.Methods: 30 terminal patients [age range 63-79, 19 women, 11 men] from the palliative care unit at Nîmes University Hospital were included in the study from 31/03/2016 to 08/11/2016. All had given written informed consent. 2 clowns visited the patients and their companions, inviting them to take part in 15 to 30-minute improvised role-plays to prepare them for the inevitable separation. Primary outcome measures for the impact of the clowns’ interventions were: The Edmonton Symptom Assessment System evaluating patients’ physical symptoms and the McGill Quality of Life Questionnaire assessing patients’ quality of life. The secondary outcome measure was Alceste textual data analysis software to analyse semi-structured interviews held with patients, their companions and carers. Results: However long the clown’s intervention, the ESAS scores indicated a significant improvement in nausea (p=0.0248) and dyspnea (p=0.0476). Scores for depression (p=0.0160) also showed an improvement. A slight difference in the scores for anxiety (p=0.0900) and drowsiness (p=0.0812) was also observed. 2 days after the clowns’ intervention, the Mc Gill scores revealed a significantly greater physical quality of life (p=0.0044) and a very slight increase in the patients’ overall quality of life (p=0.0807). Results of the lexical analysis with Alceste revealed benefits for all those involved and gave an indication for better patient management at the PCU. Conclusions: This pilot study demonstrating the impact of “clowning” on various physical and mental symptoms in adult patients indicates the benefits of such interventions for patients, their companions and carers. Although the usefulness of clowns for children with life-threatening diseases is clear, the results obtained with our study clearly indicate the benefits of these interventions in adult, end-of-life patients. Further studies would be required to confirm these findings.Date of first registration : 20/11/2015Trial registration: ClinicalTrials.gov ID: NCT02610452This research was registered under the following reference : IDRCB 2015-A00719-40 and approved by the local committee for the protection of persons, CPP Sud-Méditerranée III-Nîmes on November 6th, 2015 under the reference 2015.06.03.

Background: Although several studies on clown therapy have demonstrated benefits for children and the elderly, few studies exist on its impact on quality of life in adult end-of-life patients. We devised this monocentric, prospective, descriptive pilot study, covering quantitative and qualitative aspects, to test the hypothesis that “clowning” in the PCU would improve the quality of life of patients, and benefit their companions and caregivers. Methods: 30 end-of-life patients [age range 63-79, 19 women, 11 men] from the palliative care unit at Nîmes University Hospital were included in the study from 31/03/2016 to 08/11/2016. All had given written informed consent. 2 clowns visited patients and their companions, inviting them to participate in 15 to 30-minute improvised role-plays to prepare them for the inevitable separation. Primary outcome measures for the impact of the clowns’ interventions were: the ESAS questionnaire to evaluate patients’ physical symptoms and a Quality of Life Questionnaire assessing patients’ quality of life. Semi-structured interviews held with patients, their companions and caregivers were then analysed using textual data analysis software. Results: Statistical analyses were performed using SAS© version 9.4. qualitative variables were expressed as frequency with percentages and endpoints tested using the Wilcoxon signed rank test. However long the clown’s intervention, the ESAS scores indicated significant improvements in nausea (p=0.0248) and dyspnea (p=0.0476). Scores for depression (p=0.0160) also improved. A slight difference in the scores for anxiety (p=0.0900) and drowsiness (p=0.0812) was also observed. 2 days after the clowns’ intervention, the Mc Gill scores revealed a significantly greater physical quality of life (p=0.0044) and a very slight increase in the patients’ overall quality of life (p=0.0807). The lexical analysis revealed benefits for all involved and gave an indication for better patient management at the PCU. Conclusions: This pilot study evaluating the impact of “clowning” on various physical and mental symptoms and Quality of Life in adult patients indicates the benefits of such interventions. Indeed, benefits for all involved were also revealed by the lexical analysis. Although clowns are clearly useful for children with life-threatening diseases, our results also indicate the advantage of such interventions in adult, end-of-life patients. Further studies would be required to confirm these findings. Date of first registration : 20/11/2015 Trial registration: ClinicalTrials.gov ID: NCT02610452 This research was registered under the following reference : IDRCB 2015-A00719-40 and approved by the local committee for the protection of persons, CPP Sud-Méditerranée III-Nîmes on November 6th, 2015 under the reference 2015.06.03.