Effect of FPCA on Incidence of 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

Emergence delirium (ED) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalization periods, escalated healthcare expenses, and increased incidence of postoperative maladaptive behaviours (POMBs). There is a lack of well-established pharmacological or non-pharmacological interventions demonstrating efficacy in reducing the occurrence of ED. Therefore, our objective is to assess the potential of family-centred perioperative care for anaesthesia (FPCA) in mitigating the incidence of ED in children, compared with routine anaesthesia.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Child; Emergence Delirium; Perioperative Care; General Anaesthesia; Family
• Intervention / Treatment: Other: Family-centred perioperative care for anaesthesia

• Study Type: Interventional
• Enrollment (Estimated): 444
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Li, MD. PhD; Phone Number: +86-135-8787-6896; Email: liting1021@aliyun.com

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
      • Contact: Ting Li, MD. PhD; Phone Number: +86-135-8787-6896; Email: liting1021@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Family-Centered group (F group); Both children and parents received family-centred perioperative care for anaesthesia including video education, anaesthesia mask practice, e-manual learning,etc. It is also recommended that a parent accompany the child during both anesthesia induction and recovery.	Other: Family-centred perioperative care for anaesthesia; The patient in intervention group and parent will receive the Family-centred perioperative care for anaesthesia, including video education, anaesthesia mask practice, electronic pamphlet,etc. It is recommended that parents accompany the children during the induction of anesthesia and the recovery from anesthesia.
No Intervention: Routine group (R group); The child received clinical standard preoperative education and anesthesia induction. The child was not accompanied by the parents during the anesthesia induction period and the awakening period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of emergency delirium	The incidence of emergency delirium will be evaluated by the Pediatric Anesthesia Emergency Delirium scale (PAED). When the child wakes up in the PACU (the child can stay awake for more than 10 seconds), and 5min, 15min, 25min after waking up, a trained researcher will evaluate the PAED score (the maximum scores ≥10 will be diagnosed as ED).	At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The severity of emergency delirium	The severity of emergency delirium was assessed according to PAED scores in those patients who suffered emergency delirium. A total score ≥12 is considered moderate emergency delirium, ≥15 is considered severe emergency delirium, and the total score of the scale is 20.	At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;
The incidence of postoperative maladaptive behaviours	Postoperative maladaptive behavioural changes at the 1, 2, 3, 7±2, 14±3 days and 3 months±5 days after surgery will be assessed with Post Hospitalization Behaviour Questionnaire (PHBQ). When total score greater than 0 will be considered as postoperative maladaptive behaviours.	at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery
Sleep quality	Sleep quality before surgery and at 7±2, 14±3 days and 3 months ±5 days after surgery, assessed with Children's Sleep Habits Questionnaire (CSHQ).	Baseline before surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery
Compliance of anaesthesia induction	Compliance of anaesthesia induction in children will be assessed with Induction Compliance Checklist (ICC).	The period anaesthesia induction.
Postoperative pain score	Postoperative pain score in children will be assessed with Face, Legs, Activity, Cry, Consolability scale (FLACC).	At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake.
Preoperative anxiety of children	Preoperative anxiety of children will be assessed with the modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF).	Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.
Preoperative anxiety of parents	Preoperative anxiety of parents will be assessed with State Trait Anxiety Inventory (STAI).	Baseline before surgery, in the preoperative holding area and during induction of anaesthesia.
Quality of life score	Quality of life score will be assessed with Pediatric Quality of Life Inventory 4.0 (PedsQL4.0).	Baseline before the surgery and at 14±3 days and 3 months ±5 days after surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperament of children	Temperament of children will be evaluated by Chinese Children's Temperament Problem Screening System (CCTS).	Within 2 weeks before the surgery
Temperament of parents	Temperament of parents will be evaluated by Eysenck Personality Questionnaire (EPQ).	Within 2 weeks before the surgery

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Collaborators: Jinhua Municipal Central Hospital; The Central Hospital of Lishui City; Ningbo No.2 Hospital; Lishui Country People's Hospital
• Investigators: 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

Publications and helpful links

General Publications

• Chen J, Hu J, Zheng C, Song S, Yang C, Ye F, Li T. 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. BMJ Open. 2025 Jul 6;15(7):e089863. doi: 10.1136/bmjopen-2024-089863.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 24, 2023
• First Submitted That Met QC Criteria: October 15, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: general anaesthesia; perioperative care; paediatric; emergency delirium; postoperative maladaptive behaviours
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Postoperative Complications; Anesthesia and Analgesia; Anesthesia
• Other Study ID Numbers: SAHoWMU-CR2023-03-110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol and statistical analysis plan.
• IPD Sharing Time Frame: Beginning 6 months after publication with no end date
• IPD Sharing Access Criteria: De-identified participant data underlying the findings will be made available upon reasonable request. Proposals for data access should be directed to the corresponding author (liting1021@aliyun.com).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No