NCT06861998

Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery

The Impact of Behavioral Intervention On Postoperative Delirium In Sleep-Disordered Infants and Toddlers Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 452 (estimated)
• Sponsor: Yan Fuxia · Academic / Other
• Sex: All
• Age: 1 Day – 3 Years
• Healthy volunteers: Not accepted

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 infants and toddlers undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Brief Infant Sleep Questionnaire (BISQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received sleep hygiene education and a bedtime routine based on touch, the control group received only sleep hygiene education. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, 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. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.

Detailed description

The study will be carried out in Fuwai Hospital, Chinese Academy of Medical Sciences, Anzhen Hospital Affiliated to Capital Medical University, Fuwai Central China Cardiovascular Hospital, Fuwai Cardiovascular Hospital of Yunnan Province, and Children's Hospital Affiliated to Capital Institute of Pediatrics. The research process is as follows: Perform routine sleep disorder assessments on pediatric patients visiting the outpatient clinic. Fully inform the guardians of pediatric patients with sleep disorders of all the contents and procedures of this trial. After obtaining informed consent comprehensively and having the informed consent forms signed, conduct further assessments on the pediatric patients to determine whether they meet the inclusion and exclusion criteria. All enrolled children's guardians will receive sleep hygine education 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 children in the experimental group receive behavioral interventions every day before surgery, specifically a bedtime routine based on massage/stroking. Guardians need to strictly implement it and cooperate with the researchers through phone calls (during the waiting period for admission) or face-to-face communication (during the preoperative hospitalization period). In the control group, parents are provided with sleep hygiene education for infants and toddlers, and no additional intervention measures are applied. To better control the quality of interventions for children aged 0 - 3 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, they fill out the Brief Infant Sleep Questionnaire (BISQ) again and compare it with the baseline situation. 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

• Delirium - Postoperative
• Sleep Problems
• Congenital Heart Disease (CHD)

Interventions

Type	Name	Description
BEHAVIORAL	Message-based bedtime routine	The intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message.
BEHAVIORAL	sleep hygiene education	Sleep hygiene education includes sleep environment, sleeping location, regular sleep schedule, bedtime routines, sleeping methods, and sleeping posture.

Timeline

• Start date: 2025-04-30
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-03-06
• Last updated: 2025-05-28

Locations

1 site across 1 country: China