Suguru Kawazu ¹ Marie Amitani ^2,3* Hajime Suzuki ⁴ Haruka Amitani ¹ Takako Monuki ⁵ Midori Wada ¹ Satomi Toyohira ³ Kazumasa Hamada ¹ Takako Yamamoto ¹ Takuya Yoshimura ⁴ Kimiko Mizuma ⁶ Yuko Nishida ¹ Hiroko Watanabe ⁷ Masayuki Hirose ⁷ Koshiro Tagawa ⁷ Keiko Ota ⁸ Akihiro Asakawa ¹ Tetsuhiro Owaki ^3,6

• ¹ Division of Psychosomatic Internal Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan
• ² Education Center for Doctor in Remote Islands and Rural Areas, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Kagoshima, Japan
• ³ Division of Community-Based Medicine, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Kagoshima, Japan
• ⁴ Division of Oral and Maxillofacial Surgery, Kagoshima University Graduate School of Medical and Dental Sciences,, Kagoshima, Kagoshima, Japan
• ⁵ Multidisciplinary Pain Center, Kyushu University Hospital, Fukuoka, Japan
• ⁶ Education Center for Doctors in Remote Islands and Rural Areas, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Kagoshima, Japan
• ⁷ Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Fukuoka, Japan
• ⁸ Center for Clinical Research and Innovation, Osaka Metropolitan University Hospital, Osaka, Japan

School refusal is one of the serious problems with children's mental health, and various studies have examined its prevalence and factors among students. Although many studies suggested that anxiety and depression are deeply associated with school refusal, there is little agreement as to effective interventions. The purpose of this paper is to evaluate the efficacy and safety of mindfulness yoga intervention in children with school refusal.This study is a multicenter, exploratory, open cluster-randomized controlled trial. 43 participants aged 10-15 years with school refusal were randomly assigned to a non-yoga group with treatment as usual (TAU) which includes cognitive behavioral therapy based on self-monitoring, or a yoga group (4-week mindfulness yoga program provided by video sessions + TAU). The primary outcome was symptoms of anxiety evaluated by Spence Children's Anxiety Scale-Children (SCAS-C). Participants were assessed in four time periods: a 2-week baseline (Day -14), a baseline (Day 1), a post-test after 4 weeks of treatment (Day 29), and an 8-week follow-up (Day 85). Statistical analysis was conducted by a linear mixed effect model using SAS version 9.4.43 participants were included in the Full-analysis set (FAS) (21 in the mindfulness yoga group and 22 in the non-yoga group. The estimates of SCAS-C at post-test adjusted for baseline values in each treatment group were 39.9 in the mindfulness yoga group and 39.4 in the non-yoga group. The between-group difference for the estimates was 0.4 (80%CI -4.8 to -5.6, p=0.54), which indicated mindfulness yoga program has no significant effect on anxiety compared with TAU. However, on an exploratory analysis of the subscale of SCAS-C, significant improvement was observed on the Physical Injury Fears subscale. The pulse rate was significantly lower in the yoga group compared to the nonyoga group.This study indicated the safety of a mindfulness yoga intervention for children with school refusal, but the effectiveness of the intervention for anxiety was limited. Further research is needed to determine the long-term effects of yoga and how it can best be integrated with other therapies.