Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorYan Fuxia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Preoperative use of sleep therapy-related medications
The risk adjustment in congenital heart surgery-1 (RACHS-1 classification) ≥4
History of preoperative cardiac assist device, mechanical ventilation support, or asphyxia rescue
Emergency surgery or preoperative ICU admission
Trial design
Design model
Parallel
Treatments tested in this trial
cognitive-behavioral intervention
BehavioralAfter 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
Treatment groups
544 Participants
are divided into 2 treatment groupsGroup A: CBT groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The incidence of postoperative delirium
Time frame
Postoperative 7 daysSecondary outcomes
1
Mechanistic endpoint: Concentration of plasma S-100β protein
S-100β protein was used as a surrogate biomarker for the disruption of the blood-brain barrier.
Time frame
Before surgery, at the end of surgery and 24 hours after surgery2
Pain defined by the Wong-Baker faces pain scale (revision)
The Faces Pain Scale-Revised (FPS-R) requires patients to rate their overall pain intensity on a scale from 0 (no pain) to 10 (worst possible pain). Simultaneously, the FPS-R provides six cartoon illustrations of facial expressions (ranging from smiling, sad, to agonized crying) to visually represent the pain levels corresponding to different score ranges. This design aligns with children's concrete thinking characteristics. During assessment, the child simply points to the numerical rating or cartoon face that best matches their perceived pain intensity, making it particularly suitable for children aged 4 to 12 years.
Time frame
Postoperative 7 days3
The incidence of postoperative Acute kidney injury
Time frame
Within postoperative 7 days4
The incidence of Pulmonary complication
Time frame
Postoperative 7 daysOther outcomes
1
Long-term Sleep quality score
guardians scored sleep quality 1-5 using a sleep diary
Time frame
30 days, six months, 1 year postoperatively2
Strengths and Difficulties Questionnaire Score
The Strengths and Difficulties Questionnaire (SDQ) consists of 25 items (0-50 scores) assessing five main domains: emotional symptoms, behavioral problems, oppositional behaviors, peer relationship problems, and social competence. These dimensions allow researchers to get a comprehensive picture of a child's emotional and behavioral status, with higher scores being more severe. Guardians will be required to complete the electronic SDQ Parent Version Questionnaire at 6 months postoperatively and 1 year postoperatively
Time frame
6 months and 1 year after surgery3
Readmission rate
the rate at which a patient is readmitted to the hospital for the same or a different health problem within 30 days/six months/1 year after discharge
Time frame
30 days,6 months,1 year after discharge4
1-year mortality
the death rate of 1 year after surgery
Time frame
1 year after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Yan Fuxia
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor institution
Source ClinicalTrials.gov