Eligibility Module

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 @ 1:27 AM
Ignite Modification Date: 2025-12-25 @ 1:27 AM
NCT ID: NCT04631094
Eligibility Criteria: Inclusion Criteria: * \- The volunteerism of the child and the parent to participate in the research, * The child is between the ages of 5-12, * The child and the parent speaks Turkish, Taking blood from the cephalic vein, * Turnstile not being tied for more than 30 seconds, * Not taking any analgesic (systemic or topical), antipyretic, anti-inflammatory drugs in the last 12 hours, * Body temperature between 36.5-37.2 ⁰C, * Not having a disease that can cause chronic pain, * No acute pain or anxiety during the procedure, * Absence of skin integrity problems, * No obstacle to grip the balls in hand, * Children who do not have regular invasive interventions (no chronic diseases that require blood control such as cancer, diabetes), * Blood collection was performed at the first attempt, * The child does not have any auditory, mental or neurological disability that will affect his participation in the research. Exclusion Criteria: * \- The child and the parents are not willing to participate in the research, * The child is not between the ages of 5-12, * The child and the parent do not speak Turkish, Inability to take blood from the cephalic vein, * Turnstile remaining tied for more than 30 seconds, * Taking any medication with analgesic (systemic or topical), antipyretic or anti-inflammatory effects in the last 12 hours, * Body temperature lower than 36.5 C-37.2 ⁰C, * Having a disease that can cause chronic pain, * Children who undergo regular invasive interventions (having chronic diseases that require blood control such as cancer, diabetes), Failure to take blood at the first attempt, * Any acute pain or anxiety during the procedure, * Problems with skin integrity, * It has an obstacle to grip the balls, * Having an auditory, mental or neurological disability that will affect the child's participation in the research, * Children in the control group want or involuntarily hold their parent's hand or something else during the procedure.
Healthy Volunteers: True
Sex: ALL
Minimum Age: 6 Years
Maximum Age: 12 Years
Study: NCT04631094
Study Brief:
Protocol Section: NCT04631094