Study of Family-Centered Perioperative Care to Reduce Emergency Delirium in Children Aged 2 to 6 After Surgery
Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2025-12-29
444
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Emergence delirium ED is a common complication after surgery in young children, linked to longer hospital stays, higher healthcare costs, and increased risk of problematic behaviors after surgery. There are currently no well-established treatments to reduce ED effectively. This trial aims to evaluate whether family-centred perioperative care for anaesthesia FPCA can lower the rate of ED in children compared to standard anaesthesia care.
Children in the study are randomly assigned to one of two groups. In the family-centred care group, both children and their parents receive education through videos, practice with the anaesthesia mask, and electronic manuals. Parents are also encouraged to stay with their child during anaesthesia induction and recovery. The comparison group receives standard preoperative education and anaesthesia care without parental presence during induction and awakening.
Participants will be monitored for signs of emergency delirium immediately after waking from anaesthesia and at intervals up to 25 minutes. Researchers will also assess the severity of delirium, postoperative behavioral changes, sleep quality, quality of life, pain levels, and anxiety in both children and parents before and after surgery. The study tracks compliance during anaesthesia induction and follows participants for up to three months to evaluate longer-term outcomes.
CONDITIONS
Brief Title
Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery
Research Team
T
Ting Li, MD. PhD
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Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor
Jinhua Municipal Central Hospital
Collaborating Sponsor
Who Can Participate
Age: 2Years - 6Years
All Genders
Eligibility Criteria
You may qualify if you...
Children aged 2 to 6 years undergoing elective surgery lasting no more than 2 hours
Receiving first general anaesthesia by inhalation
Physical status classified as American Society of Anaesthesiology I or II
Parent has signed the informed consent form
You will not qualify if you...
Having important organ diseases
History of developmental delay, neuropsychiatric disease, psychological or cognitive impairment
History of severe hearing or visual impairment
Not suitable for inhalation anaesthesia as judged by researchers
Parent spends less than three months per year with the child
Parent judged not competent to provide companionship
Neither parent able to participate in screening interview and trial
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Day of surgery
Participants receive either family-centred perioperative care for anaesthesia or routine preoperative education and anesthesia induction. Parents are recommended to accompany children during anesthesia induction and recovery in the family-centred care group.
1 surgery day visit including anesthesia induction and recovery
Post-operative Follow-up
Duration - Up to 3 months after surgery
Participants are monitored for emergency delirium, postoperative maladaptive behaviours, sleep quality, quality of life, anxiety, and pain through scheduled assessments after surgery.
Multiple visits at 5, 15, and 25 minutes after awakening; postoperative days 1, 2, 3, 7±2, 14±3, and 3 months ±5 days; baseline visits before surgery
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Effect of family-centred perioperative care for anaesthesia on the incidence of emergence delirium in children after surgery: a protocol for a randomised controlled trial in China.