Actively Recruiting
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
Led by Yan Fuxia · Updated on 2025-05-31
544
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether preoperative sleep interventions can reduce the occurrence of postoperative delirium in school-aged children with sleep disorders undergoing congenital heart surgery. This multicenter, randomized, controlled clinical trial includes children aged 6 to 12 years with sleep disorders confirmed by the Children's Sleep Habits Questionnaire. The study aims to provide guidance on preventing delirium after cardiac surgery by comparing an intervention group receiving a cognitive-behavioral therapy (CBT) with a control group receiving standard care. Participants in the intervention group receive a short, intensive cognitive-behavioral intervention 7 to 14 days before surgery, delivered daily through a WeChat mini-program. Guardians help implement the therapy and record daily sleep diaries. Children wear actigraph devices before and after surgery to monitor sleep. The control group follows routine clinical practice without intervention. Researchers monitor sleep quality, pain, organ injury, and recovery outcomes during the hospital stay. Children are assessed through questionnaires, actigraphy, and sleep diaries before surgery and followed up within seven days post-surgery to evaluate delirium incidence and other health outcomes. Sleep habits are reassessed the day before surgery. Researchers also measure blood markers related to inflammation and organ function at specific perioperative times. The total study participation includes preoperative intervention, hospitalization monitoring, and postoperative follow-up until discharge or seven days after surgery.
CONDITIONS
Brief Title
Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 0 to 36 months
- Scheduled to undergo elective corrective surgery for congenital heart disease using cardiopulmonary bypass
- Sleep disorder confirmed by a Children's Sleep Habits Questionnaire score above 48
You will not qualify if you...
- Preoperative use of sleep therapy-related medications
- High surgical risk classified as RACHS-1 category 4 or above
- History of cardiac assist device use, mechanical ventilation support, or asphyxia rescue before surgery
- Emergency surgery or admission to intensive care before surgery
- Neurodevelopmental disorders such as autism spectrum disorder, ADHD, or psychiatric disorders like depression
- Severe liver and kidney dysfunction
- Presence of certain non-cardiac malformations including adenoid hypertrophy, tracheobronchial stenosis, Down syndrome, and others
- History of brain ischemia or lack of oxygen before surgery
- Participation in other clinical trials
- Family refuses consent or poor compliance by the child
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (outpatient clinic)
Duration - 7 to 14 days before surgery
Participants in the experimental group receive daily cognitive-behavioral interventions before surgery, including cognitive change, sleep hygiene, sleep restriction, stimulus control, and relaxation training. Guardians record daily sleep diaries and cooperate with researchers through phone calls or face-to-face communication.
Daily remote and in-person contacts before surgery
Duration - Surgery day and hospital stay until discharge
Participants undergo congenital heart surgery followed by immediate postoperative care including wearing actigraph devices to monitor sleep until discharge.
Continuous monitoring during hospitalization
Duration - Up to 7 days post surgery or until discharge
Participants are followed for up to 7 days after surgery or until discharge to assess outcomes such as delirium, pain, and organ function.
Daily assessments during hospital stay
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100037
Actively Recruiting
Research Team
F
Fuxia Yan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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