Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07313735
Eligibility Criteria:
Inclusion Criteria:
* Children aged 6 to 11 years at the time of enrollment.
* Hospitalized children diagnosed with superficial partial-thickness or deep partial-thickness burns (second-degree burns).
* Total Burned Body Surface Area (TBSA) ≤ 10%, calculated using the Rule of Nines or Lund-Browder chart.
* Burn location limited to upper extremities, lower extremities, or trunk.
* Scheduled to undergo routine burn dressing procedures in the pediatric ward.
* Ability of the child to communicate pain and anxiety verbally.
* Written informed consent obtained from parent or legal guardian, and assent from the child when appropriate.
Exclusion Criteria:
* Children with full-thickness (third-degree) or fourth-degree burns.
* Burns involving the face, scalp, neck, or genital region.
* TBSA \> 10%.
* Presence of cognitive impairment, developmental delay, or neurological disorder that may interfere with outcome assessment.
* Presence of chronic pain conditions or regular use of analgesics unrelated to burn treatment.
* Initial burn dressing performed in an intensive care unit (ICU).
* Refusal of the child or parent/legal guardian to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
11 Years
Study:
NCT07313735
Study Brief:
Protocol Section:
NCT07313735