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

NCT ID: NCT07088692

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-20

Study Completion Date

2026-05-20

Brief Summary

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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.

Detailed Description

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Conditions

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PTSD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Children's Hospital

OTHER

Sponsor Role collaborator

Capital Institute of Pediatrics, China

OTHER

Sponsor Role collaborator

JianHao Zhang

OTHER

Sponsor Role lead

Responsible Party

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JianHao Zhang

postgraduate student

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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

Beijing, , China

Site Status

Countries

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China

Central Contacts

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LingXin Wei

Role: CONTACT

+8613621159500

Facility Contacts

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LingXin Wei

Role: primary

+8613621159500

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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YS2024CG022

Identifier Type: -

Identifier Source: org_study_id

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