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RECRUITING
NCT06879431
NA

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

Sponsor: Yan Fuxia

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

544

Start Date

2025-04-28

Completion Date

2026-12-31

Last Updated

2025-05-31

Healthy Volunteers

No

Interventions

BEHAVIORAL

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

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, China