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 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT05203159
Eligibility Criteria:
Inclusion Criteria:
* Gestational age ≤32 weeks
* Birth Weight ≤2000 grams
* Receiving babies that the clinician following the baby deems at risk for the development of ROP
* Receiving babies who will have their first ROP examination
* No sedative, opioid and anticonvulsant medication given before/during the examination
* Parents do not have diagnosed mental or mental problems and agree to participate in the research.
Exclusion Criteria:
* Presence of a condition that interferes with pain assessment (intracranial hemorrhage, neuro-motor developmental delay, etc.)
* Diagnosed hearing loss
* Performing a different painful procedure before the ROP (one hour)
* Being connected to a mechanical ventilator
* Congenital hearing problems in family members
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
28 Weeks
Maximum Age:
32 Weeks
Study:
NCT05203159
Study Brief:
Protocol Section:
NCT05203159