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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT06933303
Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients between the age of 7 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;
* Type of burn injury: partial thickness burns with a burned area not greater than 10% at the moment of the first dressing change measurement as part of this research
Exclusion Criteria:
* Patients who received split skin grafts for their burns;
* Patients on sedatives or anti-epileptics;
* The use of pain-relieving medication other than paracetamol or ibuprofen;
* Painful additional injuries other than the burn injury;
* Patients who are nursed in isolation;
* 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);
* Retrospective exclusion if the patient in the intervention group did not look through the kaleidoscope for more than 50% of the procedure time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT06933303
Study Brief:
Protocol Section:
NCT06933303