Clinical Observation and Risk Factor Analysis of the Incidence of Postoperative PTSD in Children

NCT07088692 — Not yet recruiting, 400 participants, JianHao Zhang
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RegistryNCT07088692
StatusNot yet recruiting
Study typeObservational
Enrollment400 (Estimated)
SponsorJianHao Zhang (Other); collaborators: Beijing Children's Hospital, Capital Institute of Pediatrics, China
ConditionsPTSD
Datesstart 2025-08-20 (estimated), primary completion 2025-11-20 (estimated), completion 2026-05-20 (estimated), first posted 2025-07-28, last updated 2025-07-28
Locations1 site in China

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Those who developed PTSD during the follow-up period after enrollment were categorized in the exposuThose who did not develop PTSD during the follow-up period after enrollment were categorized as control group

+Outcome measures

Primary outcomes

  • Overall incidence of PTSD at different time points [6 months]: Morbidity of enrolled children during follow-up assessed by CPSS questionnaire

+Eligibility

Sex: All, ages: 6 Years to 12 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijingChina

+Study documents