Weighted Blankets for Pediatric Cancer Anxiety

Overseen By Barbara Shepperd

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Relapsed, Bone marrow transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

26 Participants Needed

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.

Research Team

Jennifer Olson

Principal Investigator

Children's Hospital Colorado

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo chemotherapy infusions with or without weighted blankets in a cross-over design

12 months

Multiple visits for chemotherapy infusions

Washout

30-day period between treatments to minimize confounding bias

30 days

Follow-up

Participants are monitored for anxiety and quality of life using CAM-S and Peds QL 4.0 assessments

12 months

Treatment Details

Interventions

• Weighted Blanket

Trial Overview 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.

Participant Groups

Group I: WB:UC Active Control 1 Intervention

Weighted Blanket 2nd infusion Usual Care 3rd infusion

Group II: UC:WB Active Control 1 Intervention

Usual Care 2nd infusion Weighted Blanket 3rd infusion

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Children's Hospital Colorado

Collaborator

Trials

121

Recruited

5,135,000+