Actively Recruiting
Led by Second Affiliated Hospital of Wenzhou Medical University · Updated on 2025-12-29
444
Participants Needed
1
Research Sites
13 weeks
Total Duration
S
Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor
J
Jinhua Municipal Central Hospital
Collaborating Sponsor
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
Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
T
Ting Li, MD. PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Jiaying Chen, Jintao Hu, Chanfan Zheng...
https://pubmed.ncbi.nlm.nih.gov/40623754