PTSDNCT07088692
Clinical Observation and Risk Factor Analysis of the Incidence of Postoperative PTSD in Children
An observational study of PTSD, run by JianHao Zhang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2025to 20 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
LingXin Wei, +8613621159500, weilx3934@sina.com
About this study
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.
- Conditions
- PTSD
- Keywords
- PTSD, PMTS
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of PTSD at different time points
Morbidity of enrolled children during follow-up assessed by CPSS questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start20 Aug 2025 (estimated)
- Primary completion20 Nov 2025 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JianHao Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Children's Hospital, Capital Institute of Pediatrics, China
- Responsible party
- Sponsor-investigator, JianHao Zhang, The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088692
- Sponsor's protocol ID
- YS2024CG022
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation and Risk Factor Analysis of the Incidence of Postoperative PTSD in Children
- ClinicalTrials.gov ID
- NCT07088692
- Acronym / sponsor ID
- YS2024CG022
- Conditions
- PTSD
- Keywords
- PTSD, PMTS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- JianHao ZhangUniversity, hospital or other
- Collaborators
- Beijing Children's Hospital, Capital Institute of Pediatrics, China
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall incidence of PTSD at different time points
Time frame: 6 months
Morbidity of enrolled children during follow-up assessed by CPSS questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD, run by JianHao Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LingXin Wei (+8613621159500, weilx3934@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of PTSD at different time points (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.