Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery
NCT ID: NCT06879431
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
544 participants
INTERVENTIONAL
2025-04-28
2026-12-31
Brief Summary
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Detailed Description
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The research process is as follows: Conduct a routine assessment of sleep disorders for the children visiting the outpatient clinic. The guardians fill out the online Children's Sleep Habits Questionnaire. Fully inform the children with sleep disorders and their guardians of all the contents and procedures of this trial. After obtaining informed consent and signing the informed consent form, conduct a further assessment on the children to determine whether they meet the inclusion and exclusion criteria. All enrolled children and their guardians will receive preoperative education for congenital heart disease in the outpatient clinic. After stratification by research center, the random block is set to 4 - 6, the R will be used to randomly assign subjects to the experimental group and the control group at a 1:1 ratio. After randomization, the parents of children in the experimental group register for a WeChat mini-program, and the children receive cognitive-behavioral interventions every day before surgery. Guardians need to strictly implement and cooperate with researchers through phone calls (during the waiting period for admission) or face-to-face communication (during the preoperative hospitalization period). The control group does not receive any intervention and follows routine clinical practice. To better control the quality of interventions for children aged 6 - 12 in the experimental group, the daily implementation status of parents is counted for the degree of implementation (0 - 100%) in the WeChat mini-program. Guardians record the children's daily sleep diaries (online questionnaires) before surgery. The day before surgery, parents fill out the online Children's Sleep Habits Questionnaire again and compare the scores with the baseline scores. After admission, children wear actigraphs until the day of surgery and until discharge after surgery to automatically record sleep-related information. After the children are enrolled in the study, relevant researchers will supervise the implementation of cognitive-behavioral interventions for the children once a day before surgery to ensure that the actigraph device functions properly during hospitalization and remind guardians to record electronic sleep diaries until the night before surgery. Follow-up will be conducted within 7 days after surgery or before discharge to evaluate outcomes such as delirium and pain. The primary outcome is the incidence of postoperative delirium, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CBT group
The intervention group received a short intensive cognitive-behavioral therapy (CBT) intervention 7-14 days before surgery
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
control group
no intervention was imposed on the control group
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
6 Years
12 Years
ALL
No
Sponsors
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Yan Fuxia
OTHER
Responsible Party
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Yan Fuxia
principal investigator
Principal Investigators
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Fuxia Yan
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-2602
Identifier Type: -
Identifier Source: org_study_id
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