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:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT06591195
Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients between the age of 5 and 12 years old with burn injuries requiring dressing changes in the outpatient clinic, who in regular practice (non-research setting) would not receive any analgesics other than paracetamol or a non-steroidal anti-inflammatory drug (NSAID);
* Superficial partial thickness burns \< 5% TBSA (total body surface area) at the time of injury
* Only the first change of dressing is included
Exclusion Criteria:
* Patients who underwent split skin grafts for their burns;
* Patients on sedatives or anti-epileptics;
* The use of pain-relieving medication other than paracetamol or NSAIDs;
* If it is the patient's second presentation to Ngwelezana hospital's outpatient burns department
* Painful additional injuries other than the burn injury;
* Physical or mental impairments which make it impossible to adequately comply with the trial protocol. For example, visual impairments, impaired ability to communicate, psychological comorbidities, and burns that limit the use of a kaleidoscope (facial burns or burns to both hands)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
12 Years
Study:
NCT06591195
Study Brief:
Protocol Section:
NCT06591195