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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• Age 0-36 months

• Scheduled to undergo elective corrective surgery for congenital heart disease under cardiopulmonary bypass.

• Sleep disorder assessed by Children's Sleep Habits Questionnaire (CSHQ) (CSHQ score \>48)

Locations
Other Locations
China
Fuwai Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Fuxia Yan
yanfuxia@sina.com
010 88396628
Time Frame
Start Date: 2025-04-28
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 544
Treatments
Experimental: CBT group
The intervention group received a short intensive cognitive-behavioral therapy (CBT) intervention 7-14 days before surgery
No_intervention: control group
no intervention was imposed on the control group
Related Therapeutic Areas
Sponsors
Leads: Yan Fuxia

This content was sourced from clinicaltrials.gov