An interventional study of Message-based bedtime routine and sleep hygiene education in Delirium - Postoperative, Sleep Problems and Congenital Heart Disease (CHD), sponsored by Yan Fuxia. Recruiting at 1 site in China. Open to participants aged 1 Day to 3 Years. Per ClinicalTrials.gov, last updated 2025-05-28.
Sponsored by Yan Fuxia · Not applicable, Interventional, and Treatment
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Among 185 studies in Emergence Delirium with a site in China — 64 open to participants now, 65 under way, 1 of them phase 3. Emergence Delirium · China.
Among the 185 studies in Emergence Delirium with a site in China, this one is the 28th largest by planned enrollment of the 111 interventional ones that give a count, is one of 21 that started in 2025, is one of 70 with no phase, reaches primary completion later than 17 of the 64 other live ones, and was the 133rd registered.
752 studies on the registry are indexed under Emergence Delirium; 262 are open to participants now.
Browse Emergence Delirium studies →64 of the 185 studies in Emergence Delirium with a site in China are open now. Recruiting first, the newest first:
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 65–85
Nanjing First Hospital, Nanjing Medical University · Sites in China
Ages 65–90 · Healthy volunteers
Peking University First Hospital · Sites in China
Ages 65+ · Healthy volunteers
Peking University People's Hospital · Sites in China
Ages 65+ · Healthy volunteers
Fujian Medical University Union Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 143 Emergence Delirium studies recruiting now, 79 (55%) set no upper age limit and 44 (31%) stop at 75 or younger; 34 take children under 18; 24 take healthy volunteers.
This study: 1 Day to 3 Years · all sexes · no healthy volunteers.
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185 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 21 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 452 is above the median of 120 across 466 interventional studies indexed under Emergence Delirium.
Median enrollment 225 across the 111 interventional studies, 300 across the 74 observational. Of the 74 that completed or were terminated, 2 (3%) have results posted.
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1 of 185 have an industry lead sponsor. The 10 most frequent:
Yan Fuxia is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Yan Fuxia has 5 studies filed under Emergence Delirium — fewer than ten, so there is no comparison to draw.
21 of the studies in Emergence Delirium with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06361238Phase 3The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolLiraglutide in Preventing Delirium in Diabetic Elderly After Cardiac Surgery | 2027-03-31 |
| NCT07880938The First Hospital of Jilin UniversityIntranasal Dexmedetomidine Combined With Esketamine for Emergence Quality After Suspension Laryngoscopy | 2026-12 |
| NCT07523334Peking University First HospitalImpact of Esketamine on Delayed Neurocognitive Recovery in Older Patients | 2026-12 |
| NCT07351474The First Affiliated Hospital with Nanjing Medical UniversityRemimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy | 2026-12-25 |
| NCT07394647The First Affiliated Hospital of Zhejiang Chinese Medical UniversityTranscutaneous Auricular Vagus Nerve Stimulation for Prevention of Emergence Agitation and Delirium in Children Undergoing Tonsillectomy and Adenoidectomy | 2026-12-30 |
Add all 21 to your calendar (.ics) → With an account.
Among the 185 studies in Emergence Delirium with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message.
Behavioral: Message-based bedtime routine
The control group received only sleep hygiene education.
Behavioral: sleep hygiene education
The intervention group implemented sleep hygiene education and the Message-based bedtime routine, including nutritional activities-hygiene-communication-message.
Sleep hygiene education includes sleep environment, sleeping location, regular sleep schedule, bedtime routines, sleeping methods, and sleeping posture.
The incidence of postoperative delirium
Time frame: Postoperative 7 days
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 surgery
Postoperative sleep quality
Postoperative sleep quality was assessed using the Actigraph model wGT3X-BT body movement recorder. The Actigraph model wGT3X-BT was worn from the time of admission to 7 days after surgery in order to assess the sleep quality of the subjects.
Time frame: Postoperative 7 days or before discharge
Pain defined by the Face, Legs, Activity, Cry, and Consolability scale
The FLACC scale is a simple and effective tool used to assess pain in infants and non-verbal patients. It stands for Face, Legs, Activity, Cry, and Consolability. Each of these five items is scored on a scale of 0 to 2, with a higher score indicating a greater degree of pain. The total FLACC score, ranging from 0 to 10, provides a quick and reliable assessment of the patient's pain level.
Time frame: Postoperative 7 days
The incidence of postoperative Acute kidney injury
Time frame: Within postoperative 7 days
The incidence of Pulmonary complication
Time frame: Postoperative 7 days
The incidence of postoperative Liver dysfunction
Time frame: Postoperative 7 days
Concentration of intestinal fatty acid binding protein (I-FABP)
one of markers of intestinal injury
Time frame: Before surgery, at the end of surgery and 24 hours after surgery
Concentration of zonulin
One of markers of intestinal injury
Time frame: Before surgery, at the end of surgery and 24 hours after surgery
Concentration of lipopolysaccharide (LPS)
One of markers of intestinal injury
Time frame: Before surgery, at the end of surgery and 24 hours after surgery
Concentration of lipopolysaccharide binding protein (LBP)
One of markers of intestinal injury
Time frame: Before surgery, at the end of surgery and 24 hours after surgery
Types and dosages of drugs used for postoperative sedation and analgesia
Time frame: Postoperative 7 days or before discharge
Levels of inflammatory cytokines
The inflammatory cytokines include IL-6，TNF-α，IL-1β，IFN-γ，IL-17, C-reactive protein.
Time frame: Before surgery, at the end of surgery and 24 hours after surgery
Neutrophil-to-lymphocyte ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR)
Neutrophil-to-lymphocyte ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR) are two blood biomarkers based on blood cell counts, which reflect the inflammatory and immune status of the body; they were obtained based on preoperative and postoperative blood routine tests.
Time frame: Before surgery, 24 hours after surgery
The duration of postoperative mechanical ventilation
The total hours needing mechanical ventilation support
Time frame: From the end of the surgery to discharge from the hospital,up to 30 days
The length of intensive care unit stay
The time spent in the intensive care unit.
Time frame: From the end of the surgery to discharge from the hospital,up to 30 days
The length of postoperative hospital stay
Time frame: From the end of the surgery to the day of discharge from the hospital,up to 30 days
Average daily cost
total hospitalization cost divided by total length of stay
Time frame: admission to discharge, up to 30days
Long-term Sleep quality score
guardians scored sleep quality 1-5 using a sleep diary
Time frame: 30 days, 6 months, 1 year after discharge
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 discharge
1-Year Mortality and Survival
The rate at which patients die and survive within 1 year of discharge from the hospital.
Time frame: 1 year after discharge
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Dec 2025, 8 months after the start.
Of 186 non-industry interventional studies with no phase under Emergence Delirium, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 8 months is below that.
Counting every sponsor, half of 186 studies reached it within 19 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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Yan Fuxia