Trial Summary
What is the purpose of this trial?The use of weighted blankets has been studied in the adult population but there is a lack of evidence to determine their benefit among a pediatric population, specifically oncology pediatric patients. Pediatric oncology patients routinely experience anxiety during therapy and as cure rates increase, attention has progressively turned to treating psychosocial aspects of care.
Eligibility Criteria
This trial is for pediatric oncology patients aged 4-17, who weigh over 13.5kg and are receiving outpatient chemotherapy at specific locations. It's for those with leukemia, lymphoma, solid tumors or neuro-oncologic diagnoses who haven't used weighted blankets before and can complete certain assessments in English or Spanish.Inclusion Criteria
Patients who can complete the CAM-S and CAM-T as proven by seriation screening
I can speak English and Spanish.
I weigh more than 13.5kg.
+3 more
Exclusion Criteria
I am undergoing or have had a bone marrow transplant.
I started my chemotherapy as an outpatient.
Patients who fail seriation screening during enrollment
+5 more
Participant Groups
The study is testing if using weighted blankets reduces anxiety in children with cancer during their therapy sessions. The focus is on kids getting outpatient chemo treatments to see how these blankets might improve their mental well-being.
2Treatment groups
Active Control
Group I: WB:UCActive Control1 Intervention
Weighted Blanket 2nd infusion Usual Care 3rd infusion
Group II: UC:WBActive Control1 Intervention
Usual Care 2nd infusion Weighted Blanket 3rd infusion
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital ColoradoAurora, CO
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
Children's Hospital ColoradoCollaborator