Effect of Family-centered Perioperative Care for Anesthesia (FPCA) on Incidence of Emergency Delirium and Postoperative Maladaptive Behaviors in Children After Surgery

Anesthesia Clinical Trial

Official title:

Effect of Family-centered Perioperative Care for Anesthesia (FPCA) on Incidence of Emergency Delirium and Postoperative Maladaptive Behaviors in Children After Surgery: a Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06092671
• Other study ID #: SAHoWMU-CR2023-03-110
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2023
• Est. completion date: December 2026

Study information

• Verified date: September 2023
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Ting Li, MD. PhD
• Phone: 13587876896
• Email: liting1021[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Emergency delirium (ED) is one of the most common postoperative complications in pediatric patients and is associated with an increase of hospitalization time, healthcare costs, and increased incidence of postoperative maladaptive behaviors (POMBs). There is no clear pharmacological or non-pharmacological interventions that are effective in reducing the incidence of ED or POMBs. Therefore, the investigators aimed to assess whether family-centered perioperative care for anesthesia (FPCA) reduce the incidence of ED or POMBs in children compared with conventional preoperative pharmacological interventions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

1. Children aged 2-6 years undergoing elective surgery, the estimated operation time is not more than 2 hours;

2. First inhalation general anesthesia, American Society of Anesthesiology physical status I-II;

3. unwilling to accept intravenous access (refers to the child does not actively reach out for venipuncture);

4. Father or mother signed the informed consent form.

Exclusion Criteria:

1. Important organ diseases;

2. History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment;

3. History of severe hearing or visual impairment;

4. Children who are considered by the investigator not to be suitable for inhalation anesthesia;

5. The parent participating in this trial spent less than three months with the child in a year;

6. The parent is not competent for companionship considered by the researchers.

7. Neither father nor mother was able to participate in the interviews or trial.

Related Conditions & MeSH terms

• Anesthesia
• Child
• Delirium
• Emergencies
• Family
• Postoperative Complications

Intervention

Other:
• family-focused anesthesia strategies
Including video education; mask exercises; e-manuals; distraction strategies; parental companionship. The child does not receive sedatives before surgery; During the anesthesia induction period, it is recommended that the parent be instructed by the anesthesiologist to complete the induction of inhalation of the anesthesia mask, and the parent is accompanied during the awakening period.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Temperament of children	Temperament of children will be evaluated by Chinese Children's Temperament Problem Screening System (CCTS).	Within 2 weeks before the surgery
Other	Preoperative anxiety of children	Preoperative anxiety of children will be evaluated by the modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF). The scores ranged from 23 to 100, and higher total scores indicating more severe preoperative anxiety in child.	Within 2 weeks before the surgery
Other	Temperament of parents	Temperament of parents will be evaluated by Eysenck Personality Questionnaire (EPQ).	Within 2 weeks before the surgery
Other	Preoperative anxiety of parents	Parents' preoperative anxiety will be evaluated by State Trait Anxiety Inventory (STAI).The higher the total score, the higher the anxiety level of the participants.	Within 2 weeks before the surgery; within 20 minutes after parents enter the waiting area; during procedure (at the time the child begins anesthesia induction).
Other	Compliance of anesthesia induction in children	Compliance of anesthesia induction in children will be evaluated by Induction Compliance Checklist (ICC).The scale contains 10 items. Each positive item is scored 1 point, and the higher the total score, the lower the cooperation of anesthesia induction in the child.	during procedure (at the time the child begins anesthesia induction)
Other	Postoperative pain score in children	Postoperative pain score in children will be evaluated by The Face, Legs, Activity, Cry, Consolability scale (FLACC). The highest score is 10 points, with 1-3 points indicating mild pain, 4-6 points indicating moderate pain, and 7-10 points indicating moderate to severe pain. The higher the score,the more obvious the pain of the child.	At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake; once a day after surgery until patient discharge (up to day 3)
Primary	The incidence of emergency delirium	The incidence of emergency delirium will be evaluated by the Pediatric Anesthesia Emergency Delirium scale (PAED) or the Cornell Assessment of Pediatric Delirium scale (CAPD). 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). If the child returns to the ward during this period (within 25min after awakening), CAPD will be used to evaluate.	At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;
Secondary	The incidence of postoperative delirium	The incidence of postoperative delirium (POD) will be evaluated by CAPD on the postoperative day 1 to 3. If the patient is discharged during this period, it will be assessed until the day of discharge.	once a day after surgery until patient discharge (up to day 3)
Secondary	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; once a day after surgery until patient discharge (up to day 3)
Secondary	Postoperative maladaptive behavioral	Using Post Hospitalization Behavior Questionnaire (PHBQ) to assess whether there is Postoperative maladaptive behavioral. When total score greater than 0 was considered as postoperative maladaptive behavior.	at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery
Secondary	Sleep quality	Sleep quality will be evaluated by the Children's Sleep Habits Questionnaire (CSHQ).; The scale contains 33 questions. Parents need to review the sleep behaviors that children have experienced in the past week. If the behavior described in the problem occurs 5 to 7 times a week, it is considered "normal" and is counted as 3 points; If it occurs 2-4 times a week, it is considered 'sometimes' and is counted as 2 points; If the sleep behavior ranges from 0 to 1, it is considered 'rare' and is counted as 1 point. A total score greater than 54 indicates poor sleep quality.	Within 2 weeks before the surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery
Secondary	Life quality evaluation	The quality of life will be evaluated by the Pediatric Quality of Life Inventory4.0 (PedsQL4.0).	Within 2 weeks before the surgery and at 14±3 days and 3 months ±5 days after surgery.
Secondary	Actigraphy	Actigraphy will be evaluated by actigraphy device. Patients will be asked to wear the actigraphy device from 1 day before surgery to the night before discharge.	every night from 1 day before surgery until discharge (up to day 3).
Secondary	the Working Memory	The cognitive function of children will be evaluated by the Working Memory Index of The Wechsler Preschool and Primary Scale of Intelligence -? (WPPSI-IV).	Within 2 weeks before the surgery and at 7±2 days and 3 months ±5 days after surgery
Secondary	the Processing Speed	The cognitive function of children will be evaluated by the Processing Speed Index of The Wechsler Preschool and Primary Scale of Intelligence -? (WPPSI-IV).	Within 2 weeks before the surgery and at 7±2 days and 3 months ±5 days after surgery