Family-centered care to reduce emergency delirium in children after surgery
Effect of Family-centred Perioperative Care for Anaesthesia on Incidence of Emergency Delirium in Children After Surgery: a Protocol for a Randomised Controlled Trial
This study tests if having family members involved during surgery can help young children aged 2-6 experience less confusion and distress when waking up from anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 444 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Wenzhou Medical University Academic / other |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT06092671 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2-6 years who are undergoing elective surgery with a surgical duration of no longer than 2 hours and are receiving their first general anesthesia.
Not a fit: Patients with significant organ diseases, developmental delays, or those unsuitable for inhalation anesthesia will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of emergency delirium in children after surgery, leading to improved recovery experiences and reduced healthcare costs.
How similar studies have performed: While there is limited evidence on the specific approach of FPCA, similar studies focusing on family involvement in pediatric care have shown promising results in improving postoperative outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Wenzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.