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 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT06299358
Eligibility Criteria:
Inclusion criteria:
* Babies crying more than three hours a day, three days a week, according to the Wessel technique,
* Babies are between 2 and 16 weeks postpartum,
* The baby does not have any other illness that may cause restlessness and crying,
* The baby does not have a chronic disease,
* Absence of any anomaly in the foot area that would prevent massage,
* Babies have passed the hearing test,
* Babies do not have a problem that prevents hearing,
* Infants are not receiving pharmacologic treatment for infantile colic,
* Infants are not receiving non-pharmacologic treatment for infantile colic,
* Babies are not receiving any pharmacologic (analgesic/sedative) treatment that may affect pain and comfort.
Exclusion and exclusion criteria:
* Initiation of any pharmacologic treatment that may affect colic, comfort, sleep and crying times in infants included in the study,
* Initiation of any non-pharmacologic treatment that may affect colic, comfort, sleep and crying times in infants included in the study,
* Incomplete data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Weeks
Maximum Age:
16 Weeks
Study:
NCT06299358
Study Brief:
Protocol Section:
NCT06299358