26 Participants Needed

Weighted Blankets for Pediatric Cancer Anxiety

BS
Overseen ByBarbara Shepperd
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

JO

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.
See 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
See 5 more

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
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

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+
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