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:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT07164820
Eligibility Criteria:
Inclusion Criteria:
* Term newborns (≥37 gestational weeks)
* Without neurological disorders
* Who have not undergone any painful procedure (e.g., injection, venipuncture) in the previous 24 hours
* For whom heel lance for routine screening tests is planned
* Whose parents provided written informed consent
* Who have not received analgesic or sedative medications
Exclusion Criteria:
* Clinically unstable infants before or during the procedure (e.g., respiratory distress, cardiac instability)
* Infants whose position was changed, intervention was interrupted, or procedure repeated in a way that could affect pain perception
* Parental withdrawal of consent during the procedure
* Severe restlessness or sudden physiological changes preventing pain assessment
* Infants for whom standardized data could not be collected due to protocol violations
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
1 Week
Study:
NCT07164820
Study Brief:
Protocol Section:
NCT07164820