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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT02832050
Eligibility Criteria:
Inclusion Criteria:
* Child or young person aged 5 to 17 years of age.
* Child under the care of the paediatric rheumatology team at Alder Hey Children's NHS Foundation Trust.
* Child must be expected to require at least 2 blood tests during the study period of 16 weeks as part of their routine care. All decisions regarding requirement for blood tests and/or procedures will be made solely on clinical grounds and not determined in any way by the study team.
* Sufficient time for assessment visit and preparation prior to first procedure.
* The parent or child if aged above 16 years of age has provided written, informed consent to participate in the study.
* The child aged less than 16 years has provided assent appropriate to their age.
Exclusion Criteria:
* Child unable to understand and complete Visual Analogue Scale (VAS) with support.
* Family unwilling to take part in study.
* Patient has previously received regular play therapy.
* Patient receiving psychology input for procedure-related anxiety or anxiety disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
17 Years
Study:
NCT02832050
Study Brief:
Protocol Section:
NCT02832050