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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Postoperative Complications, Child, Anesthesia, Family

Intervention / Treatment
-----------------
* Other: family-focused anesthesia strategies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged 2-6 years undergoing elective surgery, the estimated operation time is not more than 2 hours; First inhalation general anesthesia, American Society of Anesthesiology physical status I-II; unwilling to accept intravenous access (refers to the child does not actively reach out for venipuncture); Father or mother signed the informed consent form. Exclusion Criteria: Important organ diseases; History of developmental retardation, neuropsychiatric diseases, psychological or cognitive impairment; History of severe hearing or visual impairment; Children who are considered by the investigator not to be suitable for inhalation anesthesia; The parent participating in this trial spent less than three months with the child in a year; The parent is not competent for companionship considered by the researchers. Neither father nor mother was able to participate in the interviews or trial.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family-Centered group (F group)<br>Both children and parents received family-focused anesthesia strategies. | Other: family-focused anesthesia strategies<br>* 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.<br>|
| No Intervention: Routine group (R group)<br>The child received clinical standard preoperative education and anesthesia induction. It is recommended to give sedatives (such as oral midazolam or dexmedetomidine nasal drops, etc.) before surgery. 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) 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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 | 
| 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 | 
| 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. | 
| 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). | 
| 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 -Ⅳ (WPPSI-IV). | Within 2 weeks before the surgery and at 7±2 days and 3 months ±5 days after surgery | 
| 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 -Ⅳ (WPPSI-IV). | Within 2 weeks before the surgery and at 7±2 days and 3 months ±5 days after surgery |