Family-centered care to reduce emergency delirium in children after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of family-centered perioperative care for anesthesia (FPCA) in reducing the incidence of emergence delirium (ED) in children aged 2-6 years undergoing elective surgery. The trial compares FPCA with routine anesthesia practices to determine if involving family members during the perioperative period can lead to better outcomes. Emergence delirium is a common complication that can result in longer hospital stays and increased healthcare costs, making this intervention potentially significant for pediatric care.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Children aged 2-6 years undergoing elective surgery with an estimated surgical duration of no longer than 2 hours;
2. Receiving first general anaesthesia by inhalation, and American Society of Anaesthesiology (ASA) physical status I to II;
3. A parent signed the informed consent form.

Exclusion criteria:

1. Suffering important organ diseases;
2. History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment;
3. History of severe hearing or visual impairment;
4. Children are not suitable for inhalation anaesthesia considered by the researchers;
5. The parent involving in this trial spends less than three months a year with the child;
6. The parent is not competent for companionship considered by the researchers;
7. Neither father nor mother is able to participate in the screening interview and the trial.

Where it's running

• The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Ting Li, MD. PhD — Department of Anaesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
• Study coordinator: Ting Li, MD. PhD
• Email: liting1021@aliyun.com
• Phone: +86-135-8787-6896

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.