Psychomotor Rehabilitation for Pediatric Delirium: A Study Protocol for a Randomized Controlled Trial Investigating Efficacy and Brain Electrophysiological Mechanisms

Xiao Zhang,1, Yu-Qian Ren,2, Yi-Jun Shan,2 Yi-Ping Zhou,2 Jia-Ying Dou,2 Ye Lu,2 Yun Cui,2, Li-Juan Ao1, 1Department of Pediatric Rehabilitation, Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), School of Medicine, Tongji University, Shanghai, 201619, People’s Republic of China; 2Pediatric Intensive Care Unit, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200062, People’s Republic of ChinaThese authors contributed equally to this workCorrespondence: Li-Juan Ao, Department of Pediatric Rehabilitation, Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), School of Medicine, Tongji University, No. 2208 Guangxing Road, Songjiang District, Shanghai, 201619, People’s Republic of China, Tel +86 13508710081, Email aolijuan9069@163.com Yun Cui, Pediatric Intensive Care Unit, Shanghai Children’s Hospital, School of Medicine, Shanghai Jiao Tong University, No. 355 Luding Road, Putuo District, Shanghai, 200062, People’s Republic of China, Tel +86 18016488651, Email cuiyun0815@163.comPurpose: Pediatric delirium is a serious complication in critically ill children with limited effective treatments. This study aims to evaluate the efficacy and safety of Psychomotor Therapy (PMT)—a comprehensive rehabilitation system integrating motor, cognitive, emotional, and psychological domains—in treating pediatric delirium, and to characterize its underlying mechanisms through electroencephalographic (EEG) and brain network analyses.Patients and Methods: This is a single-center, assessor-blinded, randomized controlled trial. A total of 34 participants (22 children with delirium aged 2 months to 14 years, meeting Richmond Agitation-Sedation Scale RASS and Cornell Assessment of Pediatric Delirium CAPD criteria, plus 6 children without any neurological disorders, managed within the same clinical environment) will be enrolled. Participants will be randomized to receive either PMT plus routine care or routine care alone. The PMT intervention will be administered once daily for 3 days. Primary outcome is the change in CAPD score. Secondary outcomes include delirium duration, EEG parameters, length of PICU stay, and safety. Assessments will be conducted at multiple time points before and after intervention.Results: This is a study protocol; as data collection is currently ongoing (January 2023–July 2026), final results are not yet available for analysis or reporting.Conclusion: The study has been approved by the ethics boards of Shanghai Yangzhi Rehabilitation Hospital and Shanghai Children’s Hospital and will adhere to the Declaration of Helsinki. Findings will be disseminated via scientific conferences and publications. Key strengths include the first investigation of brain functional networks in pediatric delirium, incorporation of an environmental control group to mitigate confounding, and pioneering application of PMT. Limitations include single-center design and geographical restriction to Shanghai, necessitating future multi-center studies with larger samples.Keywords: randomized controlled trial, PICU, electroencephalography, brain networks, neurophysiological mechanisms, non-pharmacological intervention