Clinical Observation and Risk Factor Analysis of the Incidence of Postoperative PTSD in Children
Conditions: PTSD
Sponsor: JianHao Zhang

Clinical observation and risk factor analysis of 
the incidence of postoperative PTSD in children 
2025-05-21 
Center：Plastic Surgery Hospital, CAMS & PUMC 
Beijing Children′s Hospital, Capital Medical University 
Capital Children's Medical Center Affiliated to Capital Medical 
University 
 
 
 

1. Research Background 
Child mental health has become a key concern for society. According to data from 
UNICEF and the World Health Organization, about 20% of the 1.2 billion adolescents 
aged 10 to 19 worldwide experience mental health problems. In China, approximately 
17.6% of children and adolescents suffer from various levels of psychological issues. 
Adverse psychological experiences during childhood often continue to affect their 
emotions, behaviors, and social adaptability as they grow older. 
Preoperative anxiety, pain, unfamiliar hospital environments, and uncertainty about 
surgery may lead to the development of Post-Traumatic Stress Disorder (PTSD) in 
children undergoing general anesthesia. Severe anxiety not only increases the risk of 
PTSD but also raises the likelihood of postoperative bleeding and hematoma. Repeated 
exposure to general anesthesia may further negatively impact a child's mental health. 
Studies have shown that 10.2% of children aged 6 to 13 who undergo surgery under 
general anesthesia develop PTSD postoperatively, and 26.4% exhibit at least one PTSD-
related symptom. These children often present with behavioral withdrawal, separation 
anxiety, and sleep disturbances. Half of them may experience additional issues such as 
substance abuse, anxiety, depression, or even suicidal ideation. 
Although perioperative psychological health in children is receiving increased attention, 
there is still a lack of data on the incidence of PTSD after general anesthesia in children 
and a systematic analysis of the associated risk factors. 
References: 
1. Potemra HMK, Lin J, Bertrand AA, et al. Long-Term Effect of Multiple Operations 
on Psychosocial Function in Teenage Cleft Lip and Palate Patients. Plast Reconstr 
Surg. 2020;146(1):61e–68e. 
2. Ben Ari A, Margalit D, Udassin R, Benarroch F. Traumatic Stress among School-
Aged Pediatric Surgery Patients and Their Parents. Eur J Pediatr Surg. 
2019;29(5):437–442. doi:10.1055/s-0038-1660449 
2. Research Objective 
This study aims to investigate the incidence and associated risk 
factors of postoperative PTSD in children undergoing general 
anesthesia through a prospective, multicenter cohort design. 
3. Study Design 
3.1 Study Sites and Population 

From August 10, 2025, to November 20, 2025, this study will recruit participants from 
three centers: Plastic Surgery Hospital, Chinese Academy of Medical Sciences 
(hereinafter referred to as “Plastic Surgery Hospital”), Beijing Children’s Hospital 
affiliated with Capital Medical University (hereinafter “Children’s Hospital”), and Capital 
Institute of Pediatrics affiliated with Capital Medical University (hereinafter “Pediatrics 
Center”). 
The study will enroll children aged 6 to 12 years scheduled for elective surgery under 
general anesthesia. Exclusion criteria include: a history of psychiatric disorders or 
significant cognitive impairment, recent upper respiratory tract infection or severe 
pulmonary disease (within the past two weeks), undergoing emergency surgery or 
trauma-related surgery under general anesthesia, or preoperative chronic pain. 
All perioperative data potentially related to the development of PTSD will be collected. 
Each patient will be followed up by email at one month and six months after surgery. 
3.2 Inclusion and Exclusion Criteria 
Inclusion Criteria: 
• 
Children aged 6–12 years scheduled for elective surgery under general 
anesthesia. 
• 
Parent or legal guardian provides informed consent and agrees to complete a 
1-year follow-up. 
Exclusion Criteria: 
• 
History of psychiatric disorders (e.g., PTSD, anxiety disorders), substance abuse, 
long-term use of steroids or hormonal medications. 
• 
Significant cognitive impairment that hinders understanding of study 
procedures. 
• 
Emergency surgery or trauma-related procedures requiring urgent general 
anesthesia. 
• 
Recent (within two weeks) upper respiratory tract infection or severe pulmonary 
disease. 
Withdrawal Criteria: 
• 
Serious adverse events: including but not limited to intraoperative anaphylactic 
shock, severe respiratory depression, cardiac arrest, etc. 
• 
Voluntary withdrawal: participants can withdraw from the study at any time 

without providing a reason. 
• 
Non-compliance: inability or unwillingness to adhere to the study protocol and 
procedures. 
• 
Investigator judgment: based on clinical assessment, the investigator may 
determine that continued participation poses a risk or is not appropriate. 
3.3 Assessment Schedule 
Step 
Screening 
Surgery 
Day (Day 
0) 
Postoperative 
Days 
Day 
30 
Day 
180 
Informed Consent 
✓ 
 
 
 
 
Basic Clinical 
Information 
✓ 
 
 
 
 
Clinical Diagnosis 
 
✓ 
 
 
 
Medical History 
✓ 
 
 
 
 
Laboratory Tests 
✓ 
 
 
 
 
Child Trait Anxiety 
(STAI) 
✓ 
 
 
 
 
Child Anxiety Level 
(VAS) 
 
 
✓ (Day 1–3) 
 
 
Child Depression (CDI, 
pre-op) 
✓ 
 
 
 
 
Child Depression 
(SMFQ) 
 
 
 
✓ 
 
Child PTSD Symptoms 
(CPSS) 
✓ 
 
 
✓ 
✓ 
Parent State Anxiety 
(STAI) 
✓ 
✓ 
✓ 
 
 
Parent Trait Anxiety 
(STAI) 
✓ 
 
 
 
 
Social Support (SSRS) ✓ 
 
 
 
 
Inclusion/Exclusion 
Criteria 
✓ 
 
 
 
 

Step 
Screening 
Surgery 
Day (Day 
0) 
Postoperative 
Days 
Day 
30 
Day 
180 
Surgery and Anesthesia 
Data 
 
✓ 
 
 
 
Preoperative 
Anxiolytics 
 
✓ 
 
 
 
Parental Satisfaction 
(Likert) 
 
 
 
✓ 
 
Post-op Pain (FPS-R) 
 
 
✓ (Day 1–3) 
 
 
Anesthesia 
Complications 
 
✓ 
✓ 
 
 
Surgical Complications  
 
✓ 
✓ 
 
Safety Assessment 
✓ 
 
 
 
 
Adverse Event 
Monitoring 
 
 
✓ 
 
 
CRF Completion 
 
✓ 
 
 
 
 
3.4 Observational Indicators 
1) Surgery and Anesthesia-related Factors: 
• 
Surgical type: The specific name of the surgery will be recorded in detail and 
classified into four levels (I–IV) based on complexity, technical difficulty, and risk 
level. 
• 
Duration of anesthesia: Measured in minutes. 
• 
Recovery time (PACU/ICU): Time from entering PACU/ICU postoperatively to 
full recovery, measured in minutes. 
• 
Length of hospital stay: Number of hospitalization days. 
• 
Preoperative anxiolytic medication/intervention: Whether anxiolytic 
medication or psychological measures were used before surgery, and the type 
used. 
• 
Overall surgical satisfaction: Measured using the Likert scale. Scores ≥4 are 

considered satisfactory, <4 are unsatisfactory. 
• 
Postoperative pain: Evaluated using the Faces Pain Scale-Revised (FPS-R). 
Score 4 indicates mild pain, 6 moderate, 8 severe, 10 extreme. Pain scores on 
postoperative days 1, 2, and 3, as well as frequency, will be recorded. Pain is 
defined as clinically significant if the score is ≥6 and lasts ≥2 hours. 
• 
Anesthesia-related complications: Evaluated using Clavien-Dindo 
classification. Grade ≥II is considered moderate or higher. 
• 
Surgery-related complications: Evaluated using Clavien-Dindo classification. 
Grade ≥II is considered moderate or higher. 
2) Child-related Factors: 
• 
Age and Gender: Recorded in years and categorized as male/female. 
• 
Height and Weight: Measured using standard protocol (cm and kg). 
• 
Anxiety level: Preoperatively assessed by State-Trait Anxiety Inventory (STAI); 
postoperatively by Visual Analogue Scale (VAS). 
• 
Depression level: Preoperatively measured with Children’s Depression 
Inventory (CDI); postoperatively with Short Mood and Feelings Questionnaire 
(SMFQ). 
• 
Baseline PTSD screening score: Assessed using the Child PTSD Symptom Scale 
(CPSS). 
• 
Number of previous surgeries under general anesthesia: As reported by 
parents. 
• 
History of psychological trauma: Based on parent or child report (e.g., history 
of abuse, accidents). 
• 
Preoperative psychological preparation: Whether psychological counseling or 
education was provided before surgery. 
3) Family-related Factors: 
• 
Parental anxiety levels: Measured with STAI at preoperative, intraoperative, 
and postoperative stages. 
• 
Single-parent status: Recorded as 0 = non-single-parent, 1 = single-parent. 
• 
Only child status: 0 = has siblings, 1 = only child. 
• 
Parental educational level: Assessed via questionnaire (junior high, vocational 

school, high school, college, bachelor’s, graduate). 
• 
Household income: Recorded in 10,000 yuan increments annually. 
• 
Social support level: Measured with the Social Support Rating Scale (SSRS). 
• 
Parent–child relationship type: Categorized as 1. Democratic; 2. Indulgent; 3. 
Authoritarian; 4. Neglectful. 
 
4. Data Management and Statistical Analysis Plan 
Data Management: 
All data will be managed via an electronic data capture (EDC) system operated by a 
third-party provider. This system is a standard tool in modern clinical research, ensuring 
data security, integrity, and traceability through role-based access control and audit 
trails. 
Personally identifiable information such as name, ID number, or address will not be 
collected. All data will be de-identified (e.g., “Subject 001, a child from region X, age Y”), 
ensuring participant confidentiality even in the event of a data breach. 
In case of a data breach: 
• 
Timely reporting to data governance bodies and the ethics committee. 
• 
Investigation into the cause, scope, and participant impact. 
• 
Corrective actions such as system upgrades or enhanced encryption. 
• 
Policy revision for better future protection. 
• 
Legal compliance and assumption of any resulting responsibilities by the 
research institution. 
Statistical Analysis: 
• 
Descriptive statistics: Mean ± SD for normally distributed continuous variables; 
median (IQR) for skewed data; frequency (%) for categorical data. 
• 
Primary outcome: Overall incidence of PTSD and 95% confidence interval (CI). 
• 
Secondary outcomes: PTSD incidence at 1 month and 6 months post-op and 
95% CI. Compare time-point differences using Chi-square or Fisher’s exact test. 
• 
Risk factor analysis: 

o 
Univariate analysis: t-tests for normal continuous variables, Mann-
Whitney U test for skewed data, and Chi-square/Fisher’s exact test for 
categorical variables. 
o 
Multivariate analysis: Variables with P<0.1 from univariate analysis will 
enter binary logistic regression to identify independent risk factors. 
• 
Subgroup analysis: Based on clinical or demographic characteristics (e.g., age, 
sex, surgery type) to evaluate effect modifications. 
5. Bias Control 
• 
Selection bias: Minimized through clearly defined inclusion and exclusion 
criteria and data collection from multiple centers to enhance external validity. 
• 
Information bias: Standardized data collection procedures, use of validated 
scales, and repeated assessments at multiple time points to minimize 
measurement errors. 
• 
Measurement bias: Multiple instruments are used to assess not only children’s 
psychological health but also environmental and family factors. All evaluators, 
particularly those assessing psychological outcomes, will be professionally 
trained and subject to regular quality control. 
• 
Confounding bias: Multivariable regression models will adjust for potential 
confounders. At the design stage, confounders such as age and gender can be 
balanced using matching methods like Propensity Score Matching (PSM). 
• 
Attrition bias: Strategies will include long-term follow-up and maintaining 
contact with participants. Appropriate methods for handling missing data will be 
applied to reduce bias. 
• 
Time bias: Standardized follow-up time points are set to ensure data 
comparability. 
 
6. Quality Control 
• 
All research staff will strictly follow SOPs and the approved study protocol. 
• 
Data must be recorded promptly, directly, accurately, and clearly, with 
signatures and dates. 
• 
Regular internal audits will be conducted to ensure data accuracy and 
completeness. Corrections must follow standardized procedures. 

• 
Validated statistical software will be used for data analysis, and double data 
entry will be adopted for input accuracy. 
7. Safety Assessment 
• 
The study protocol adheres to clinical practice standards and is not expected to 
pose any serious risk to participant life or safety. 
8. Adverse Event Reporting 
• 
Definition of Adverse Events (AEs): 
AEs refer to negative outcomes during diagnosis or treatment caused by factors 
other than the natural course of the disease. In this study, common AEs may 
include emotional distress during follow-up (e.g., emotional fluctuations caused 
by recalling traumatic events, or repeated psychological assessments increasing 
psychological burden) and inconvenience from remote interviews affecting the 
accuracy or effectiveness of assessments. 
• 
Documentation and Reporting of AEs: 
If an AE occurs during the study, the time of occurrence and handling details 
must be recorded in the original medical record. A serious AE form must be 
completed and submitted to the clinical research center within 24 hours for 
events that pose a significant threat to participant health or safety. 
• 
Prevention and Handling of AEs: 
Before participation, children and their guardians will receive a detailed 
explanation of the study's purpose, procedures, potential risks, and benefits to 
ensure informed consent. Evaluations will be conducted by trained personnel 
using appropriate interview techniques to minimize psychological burden. A 
stable and reliable telemedicine platform with technical support will be used to 
ensure smooth remote assessments. Participants will be compensated for travel 
or time lost. A detailed AE reporting and handling protocol will be implemented 
for timely and appropriate responses. 
9. Ethical Review and Informed Consent 
• 
9.1 Ethical Approval: 
The study protocol, informed consent forms, and participant-related materials 
were submitted to the Ethics Committee of the Plastic Surgery Hospital, Chinese 
Academy of Medical Sciences, and received approval on June 3, 2025 (Approval 
No. [2025] Registration No. 178). Researchers are required to submit an annual 
report to the ethics committee (if applicable). In case of study termination or 
completion, a written notification must be submitted. Any changes to the 
protocol or informed consent documents must be approved by the ethics 
committee prior to implementation, unless immediate changes are needed to 

protect participants from direct risk, in which case the ethics committee will be 
informed afterward. 
• 
9.2 Informed Consent: 
Investigators must provide participants or their guardians with an easy-to-
understand and ethics-approved informed consent form, allowing sufficient 
time for consideration. Written informed consent must be obtained before 
enrollment. Updated versions of consent forms and related information will be 
shared with participants during the study. All signed consent forms will be 
retained as essential clinical trial documents. 
10. Publication Plan 
• 
The results of this study may be published in medical journals. However, in 
accordance with legal requirements, all patient information will remain 
confidential. Personal data will not be disclosed unless required by law. If 
necessary, government regulatory authorities, the hospital ethics committee, 
and relevant personnel may access patient records as per regulations.