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

J

JianHao Zhang

Status

Not yet enrolling

Conditions

PTSD

Study type

Observational

Funder types

Other

Identifiers

NCT07088692
YS2024CG022

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

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.

Trial design

400 participants in 1 patient group

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

Trial documents
1

Trial contacts and locations

1

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Central trial contact

LingXin Wei

Data sourced from clinicaltrials.gov

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