Clinical Observation and Risk Factor Analysis of the Incidence of Postoperative PTSD in Children
1 other identifier
observational
400
1 country
1
Brief Summary
Preoperative anxiety, pain, and repeated exposure to general anesthesia may increase the risk of post-traumatic stress disorder (PTSD) in children. This study aims to establish a clinical database by collecting the incidence and risk factors of PTSD in children aged 6 to 12 undergoing elective surgery under general anesthesia, with a primary focus on evaluating the overall postoperative PTSD incidence, its incidence at different time points, and identifying potential risk factors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2025
CompletedFirst Posted
Study publicly available on registry
July 28, 2025
CompletedStudy Start
First participant enrolled
August 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2026
ExpectedJuly 28, 2025
July 1, 2025
3 months
July 20, 2025
July 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall incidence of PTSD at different time points
Morbidity of enrolled children during follow-up assessed by CPSS questionnaire
6 months
Study Arms (1)
Those who developed PTSD during the follow-up period after enrollment were categorized in the exposu
Those who did not develop PTSD during the follow-up period after enrollment were categorized as control group
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- JianHao Zhanglead
- Beijing Children's Hospitalcollaborator
- Capital Institute of Pediatrics, Chinacollaborator
Study Sites (1)
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- postgraduate student
Study Record Dates
First Submitted
July 20, 2025
First Posted
July 28, 2025
Study Start
August 20, 2025
Primary Completion
November 20, 2025
Study Completion (Estimated)
May 20, 2026
Last Updated
July 28, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share