Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery
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Source: NCT06879431, who can take part
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- Who runs it
- Yan Fuxia
- Trial code
- NCT06879431
- Record updated
- 31 May 2025
- Original description
This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered school-aged children undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Children's Sleep Habits Questionnaire (CSHQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received a short intensive cognitive-behavioral intervention 7-14 days before surgery, and no intervention was imposed on the control group. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.Read full original descriptionShow less
The Impact of Cognitive Behavioral Intervention On Postoperative Delirium In School-aged Children With Sleep Disorder Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial
This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered school-aged children undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Children's Sleep Habits Questionnaire (CSHQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received a short intensive cognitive-behavioral intervention 7-14 days before surgery, and no intervention was imposed on the control group. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.
Inclusion: Age 0-36 months; Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass; Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score >48).
Exclusion: Preoperative use of sleep therapy-related medications; Emergency surgery or preoperative ICU admission; Concurrent participation in other clinical trials; The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4; History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue; History of neurodevelopmental disorders such as autism spectrum disorder, attention deficit hyperactivity disorder, or psychiatric disorders such as depression; Combination of non-cardiac malformations (adenoid hypertrophy, tracheobronchial stenosis, polysplenism, anaplastic syndrome, Down syndrome, DiGeoge syndrome, diabetes mellitus, reproductive system abnormalities, anal atresia and Williams syndrome, eye disorders); History of preoperative cerebral ischemia and hypoxia; Combined severe hepatic and renal dysfunction; Refusal of the family to sign the informed consent form or poor compliance by the child.