Postoperative Chronic PainNCT07120399
Postoperative Chronic Pain in Children Aged 8 to 17
An observational study of Postoperative Chronic Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study is to assess the incidence of chronic postoperative pain in pediatric patients aged 8 to 17 years following surgical procedures. Furthermore, it seeks to identify potential risk factors contributing to the development of such pain and to evaluate its long-term implications. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Postoperative Chronic Pain
- How many people
- 323 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 15 Aug 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients aged 8 to 17 years who underwent surgical procedures at Kocaeli University
Who may be able to join
- Voluntary participation
- Undergoing a surgical procedure under anesthesia at our hospital
- Availability of complete patient data for a 6-month postoperative follow-up period
Who cannot join
- Presence of speech or communication disorders
- Development of postoperative complications
- Undergoing any additional surgical procedure for any reason during the 6 months follow-up period
- Having diagnosed psychiatric or neurological disorders
- Having a pre-existing history of chronic or long-term pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kocaeli University Faculty of Medicine
Kocaeli, Izmit, 41100
Onur ERDEM, Medical Doctor, +905526904115, mdonurerdem@gmail.com
About this study
Official title: Investigation of the Incidence of Postoperative Chronic Pain in Children Aged 8 to 17 Years
The objective of this study is to assess the incidence of chronic postoperative pain in pediatric patients aged 8 to 17 years following surgical procedures. Furthermore, it seeks to identify potential risk factors contributing to the development of such pain and to evaluate its long-term implications.
Read the detailed description
Children aged 8 to 17 years who have undergone surgery at Kocaeli University Faculty of Medicine and voluntarily agree to participate in the study for a duration of six months will be included.
Children with speech or communication disorders, those who experience postoperative complications, those with psychiatric or neurological conditions, or those with a history of chronic or long-term pain will be excluded from the study.
The participants and their families will be informed about the purpose of the study, the procedures to be followed, the duration of the study, and any potential risks. Written informed consent will be obtained from the parents of all participants. In addition, participants will be asked to complete the informed consent form.
Each participant will be asked to allocate approximately 15 minutes to complete the questionnaires and assessment tools used in the study.
Data such as age, gender, weight, height, ASA score, medical and surgical history, type of surgery, incision size, surgical site, duration of surgery, type of anesthesia and analgesia used, medication doses, intraoperative anesthesia records, length of hospital stay, and any surgical complications will be recorded.
To assess pain intensity, the Numeric Rating Scale (NRS) will be used, and to evaluate quality of life, the Pediatric Quality of Life Inventory 4.0 (PedsQL), which has a validated Turkish version, will be utilized.
These assessment tools will be administered at the following time points: preoperative period, at discharge, and on postoperative day 7, as well as at 1 month, 3 months, and 6 months after surgery.
- Conditions
- Postoperative Chronic Pain
- Keywords
- Pain, Postoperative Chronic Pain, Quality of Life
- Medical subject headings
- Pain, Postoperative, Pain
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 |
|---|---|---|
| Postoperative pediatric patients aged 8-17 | Children aged 8 to 17 years who have undergone surgery and voluntarily agree to participate in the study for a period of six months will be included. To evaluate pain intensity, the Numeric Rating Scale (NRS) will be utilized, while the Pediatric Quality of Life Inventory 4.0 (PedsQL) will be used to assess quality of life. The assessment parameters will be administered at multiple time points: in the preoperative period, at discharge, and on postoperative day 7, as well as at 1 month, 3 months, and 6 months following surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) is a commonly used pain assessment tool that consists of a numerical scale ranging from 0 to 10. On this scale, 0 indicates no pain, 1 to 3 represents mild pain, 4 to 6 indicates moderate pain, 7 to 9 reflects severe pain, and 10 corresponds to unbearable pain. Patients are asked to select the number that best describes the intensity of pain they are experiencing.
Measured: Six months
Secondary outcomes (1)
The Pediatric Quality of Life Inventory (PedsQL)
The Pediatric Quality of Life Inventory (PedsQL) is a tool designed to measure the quality of life in children and adolescents by assessing their physical, emotional, social, and school functioning. It can be used in both healthy individuals and children with chronic health conditions.
The PedsQL 4.0 consists of a total of 23 items grouped into four subscales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). The inventory includes two parallel forms: one for the child and one for the parent.
The items are rated using a 5-point Likert scale, where:
0 = Never a problem
- = Almost never a problem
- = Sometimes a problem
- = Often a problem
- = Almost always a problem
Scores are transformed so that higher scores indicate better quality of life. Score ranges are interpreted as follows:
80-100: Very good quality of life 60-79: Moderate quality of life 40-59: Low quality of life 0-39: Very low quality
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Chronic PainStudies 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
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur ERDEM, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07120399
- Sponsor's protocol ID
- GOKAEK-2025/06/39
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 14 Aug 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 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Incidence of Postoperative Chronic Pain in Children Aged 8 to 17 Years
- ClinicalTrials.gov ID
- NCT07120399
- Acronym / sponsor ID
- GOKAEK-2025/06/39
- Conditions
- Postoperative Chronic Pain
- Keywords
- Pain, Postoperative Chronic Pain, Quality of Life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 13 Aug 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.
The objective of this study is to assess the incidence of chronic postoperative pain in pediatric patients aged 8 to 17 years following surgical procedures. Furthermore, it seeks to identify potential risk factors contributing to the development of such pain and to evaluate its long-term implications.
Detailed description
Children aged 8 to 17 years who have undergone surgery at Kocaeli University Faculty of Medicine and voluntarily agree to participate in the study for a duration of six months will be included.
Children with speech or communication disorders, those who experience postoperative complications, those with psychiatric or neurological conditions, or those with a history of chronic or long-term pain will be excluded from the study.
The participants and their families will be informed about the purpose of the study, the procedures to be followed, the duration of the study, and any potential risks. Written informed consent will be obtained from the parents of all participants. In addition, participants will be asked to complete the informed consent form.
Each participant will be asked to allocate approximately 15 minutes to complete the questionnaires and assessment tools used in the study.
Data such as age, gender, weight, height, ASA score, medical and surgical history, type of surgery, incision size, surgical site, duration of surgery, type of anesthesia and analgesia used, medication doses, intraoperative anesthesia records, length of hospital stay, and any surgical complications will be recorded.
To assess pain intensity, the Numeric Rating Scale (NRS) will be used, and to evaluate quality of life, the Pediatric Quality of Life Inventory 4.0 (PedsQL), which has a validated Turkish version, will be utilized.
These assessment tools will be administered at the following time points: preoperative period, at discharge, and on postoperative day 7, as well as at 1 month, 3 months, and 6 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative pediatric patients aged 8-17 | – | –Children aged 8 to 17 years who have undergone surgery and voluntarily agree to participate in the study for a period of six months will be included. To evaluate pain intensity, the Numeric Rating Scale (NRS) will be utilized, while the Pediatric Quality of Life Inventory 4.0 (PedsQL) will be used to assess quality of life. The assessment parameters will be administered at multiple time points: in the preoperative period, at discharge, and on postoperative day 7, as well as at 1 month, 3 months, and 6 months following surgery. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 8 to 17 years who underwent surgical procedures at Kocaeli University
Key inclusion criteria (3 listed)
- Voluntary participation
- Undergoing a surgical procedure under anesthesia at our hospital
- Availability of complete patient data for a 6-month postoperative follow-up period
Key exclusion criteria (5 listed)
- Presence of speech or communication disorders
- Development of postoperative complications
- Undergoing any additional surgical procedure for any reason during the 6 months follow-up period
- Having diagnosed psychiatric or neurological disorders
- Having a pre-existing history of chronic or long-term pain
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
The Numeric Rating Scale (NRS)
Time frame: Six months
The Numeric Rating Scale (NRS) is a commonly used pain assessment tool that consists of a numerical scale ranging from 0 to 10. On this scale, 0 indicates no pain, 1 to 3 represents mild pain, 4 to 6 indicates moderate pain, 7 to 9 reflects severe pain, and 10 corresponds to unbearable pain. Patients are asked to select the number that best describes the intensity of pain they are experiencing.
1 secondary outcome
The Pediatric Quality of Life Inventory (PedsQL)
Time frame: Six months
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 14 Aug 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 Postoperative Chronic Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 14 Aug 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 Turkey (Türkiye). 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 Onur ERDEM, Medical Doctor (+905526904115, mdonurerdem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numeric Rating Scale (NRS) (time frame: Six 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 14 Aug 2025.