Back to resultsEffect of Family-centered Perioperative Care for Anesthesia (FPCA) on Incidence of Emergency Delirium and Postoperative Maladaptive Behaviors in Children After Surgery
Primary Purpose
Postoperative Complications, Child, Anesthesia
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
family-focused anesthesia strategies
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Complications
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.
Sites / Locations
- The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Family-Centered group (F group)
Routine group (R group)
Arm Description
Both children and parents received family-focused anesthesia strategies.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Life quality evaluation
The quality of life will be evaluated by the Pediatric Quality of Life Inventory4.0 (PedsQL4.0).
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.
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).
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).
Full Information
NCT ID
NCT06092671
First Posted
September 24, 2023
Last Updated
October 15, 2023
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT06092671
Brief Title
Effect of Family-centered Perioperative Care for Anesthesia (FPCA) on Incidence of Emergency Delirium and Postoperative Maladaptive Behaviors in Children After Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications, Child, Anesthesia, Family
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Family-Centered group (F group)
Arm Type
Experimental
Arm Description
Both children and parents received family-focused anesthesia strategies.
Arm Title
Routine group (R group)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
family-focused anesthesia strategies
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of emergency delirium
Description
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.
Time Frame
At the time patient awake from anesthesia after the sugery; 5min after awake; 15min after awake; 25min after awake;
Secondary Outcome Measure Information:
Title
The incidence of postoperative delirium
Description
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.
Time Frame
once a day after surgery until patient discharge (up to day 3)
Title
The severity of emergency delirium
Description
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.
Time Frame
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)
Title
Postoperative maladaptive behavioral
Description
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.
Time Frame
at postoperative days 1, 2, 3, 7±2, 14±3 days and 3 months ±5 days after surgery
Title
Sleep quality
Description
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.
Time Frame
Within 2 weeks before the surgery; at 7±2, 14±3 days and 3 months ±5 days after surgery
Title
Life quality evaluation
Description
The quality of life will be evaluated by the Pediatric Quality of Life Inventory4.0 (PedsQL4.0).
Time Frame
Within 2 weeks before the surgery and at 14±3 days and 3 months ±5 days after surgery.
Title
Actigraphy
Description
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.
Time Frame
every night from 1 day before surgery until discharge (up to day 3).
Title
the Working Memory
Description
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).
Time Frame
Within 2 weeks before the surgery and at 7±2 days and 3 months ±5 days after surgery
Title
the Processing Speed
Description
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).
Time Frame
Within 2 weeks before the surgery and at 7±2 days and 3 months ±5 days after surgery
Other Pre-specified Outcome Measures:
Title
Temperament of children
Description
Temperament of children will be evaluated by Chinese Children's Temperament Problem Screening System (CCTS).
Time Frame
Within 2 weeks before the surgery
Title
Preoperative anxiety of children
Description
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.
Time Frame
Within 2 weeks before the surgery
Title
Temperament of parents
Description
Temperament of parents will be evaluated by Eysenck Personality Questionnaire (EPQ).
Time Frame
Within 2 weeks before the surgery
Title
Preoperative anxiety of parents
Description
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.
Time Frame
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).
Title
Compliance of anesthesia induction in children
Description
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.
Time Frame
during procedure (at the time the child begins anesthesia induction)
Title
Postoperative pain score in children
Description
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.
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Li, MD. PhD
Phone
13587876896
Email
liting1021@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Person(s) responsible for the overall scientific leadership of Li, MD. PhD
Organizational Affiliation
Second Affiliated Hospital of Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Family-centered Perioperative Care for Anesthesia (FPCA) on Incidence of Emergency Delirium and Postoperative Maladaptive Behaviors in Children After Surgery
We'll reach out to this number within 24 hrs