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Behavioral Sleep Intervention to Reduce Postoperative Delirium in Infants and Toddlers with Sleep Disorders Undergoing Congenital Heart Surgery
Led by Yan Fuxia · Updated on 2025-05-28
452
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying infants and toddlers with sleep disorders who are undergoing elective congenital heart surgery to see if preoperative sleep interventions can reduce negative outcomes like postoperative delirium. This randomized controlled trial compares sleep hygiene education alone to sleep hygiene education combined with a bedtime routine involving massage. The study aims to provide insights for preventing delirium after heart surgery in young children. Participants will be randomly assigned to one of two groups an intervention group receiving sleep hygiene education plus a massage-based bedtime routine, and a control group receiving only sleep hygiene education. The intervention involves daily behavioral routines carried out before surgery, with guardians supported through phone or face-to-face contacts and tracking via a WeChat mini-program. Sleep diaries and actigraph devices will be used to monitor sleep before and after surgery. During the study, guardians will complete sleep questionnaires and record sleep patterns, while children will wear actigraphs to track sleep automatically. Researchers will supervise intervention adherence daily until surgery. After surgery, participants will be monitored for seven days or until discharge for outcomes including delirium incidence, sleep quality, pain, organ injury, and recovery. Various blood markers and clinical data will also be collected to assess effects and prognosis.
CONDITIONS
Brief Title
Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery
Research Team
F
Fuxia Yan
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