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Clinical Trials in China / NCT06879431
Recruiting Not applicable

Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery

NCT06879431 · tracked via the Priya Life Science China tracker
Sponsor
Yan Fuxia
Phase
Not applicable
Started
2025-04-28
Last updated
2025-05-31

Condition(s) studied

Delirium - PostoperativeSleep ProblemsCongenital Heart Disease (CHD)

Investigational drug(s) / intervention(s)

cognitive-behavioral intervention

cognitive-behavioral intervention: After enrollment in the experimental group, the guardians were asked to fill out a sleep diary every day before surgery to self-report the children's sleep, and to wear a somatic movement recorder to monitor sleep (non-dominant arm) (wGT3x-BT accelerometer, ActiGraph) during the preoperative hospitalization period, except during surgery, and then to wear it to record the sleep-related parameters until 7 days after surgery or before discharge from the hospital.Preoperative daily cognitive-behavioral interventions (developmental trials were guided with WeChat applets), including cognitive change, sleep hygiene, sleep restriction, stimulus control, and relaxation training

Study summary

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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 0-36 months 2. Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass. 3. Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score \>48) Exclusion Criteria: 1. Preoperative use of sleep therapy-related medications 2. The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4 3. History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue 4. Emergency surgery or preoperative ICU admission 5. History of neurodevelopmental disorders such as autism spectrum disorder, attention deficit hyperactivity disorder, or psychiatric disorders such as depression 6. Combined severe hepatic and renal dysfunction 7. 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) 8. History of preoperative cerebral ischemia and hypoxia 9. Concurrent participation in other clinical trials 10. Refusal of the family to sign the informed consent form or poor compliance by the child

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fuwai Hospital, Chinese Academy of Medical Sciences Beijing China Recruiting

More Yan Fuxia trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06879431 on ClinicalTrials.gov ↗ ← All trials in China