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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether weighted blankets can ease anxiety in children undergoing cancer treatment. Many young patients experience anxiety during chemotherapy, and weighted blankets might offer comfort. The trial will compare two groups: one using a weighted blanket during their third infusion and the other during their second infusion. Children newly diagnosed with cancer and receiving outpatient chemotherapy might be suitable if they do not already use weighted blankets at home. As an unphased trial, this study provides a unique opportunity for patients to contribute to research that could enhance comfort during treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using weighted blankets to help with anxiety, so it's unlikely to require changes to your medication.

What prior data suggests that weighted blankets are safe for pediatric oncology patients?

Research has shown that weighted blankets can help reduce anxiety in children with cancer after chemotherapy. These blankets are considered safe and effective for managing anxiety. Although more research is needed on their use with children, studies suggest that kids generally tolerate them well. No reports of serious side effects have emerged from using these blankets, making them a promising option for easing anxiety in young patients.12345

Why are researchers excited about this trial?

Researchers are excited about using weighted blankets for pediatric cancer anxiety because they offer a non-pharmacological approach to managing anxiety. Unlike standard treatments involving medication, which can have side effects, weighted blankets provide a gentle, calming pressure that can help soothe anxiety without additional drugs. This method may be particularly appealing for children, as it is simple, non-invasive, and can be easily integrated into their usual care routines. The potential for a comforting, side-effect-free option is what makes this approach stand out.

What evidence suggests that weighted blankets are effective for pediatric cancer anxiety?

Research has shown that weighted blankets can help reduce anxiety in children with cancer. In this trial, participants will receive either usual care followed by a weighted blanket during the third infusion or a weighted blanket during the second infusion followed by usual care. One study found that anxiety levels dropped by an average of 0.71 points when using weighted blankets, especially after chemotherapy treatments. Another study found that these blankets significantly eased sudden anxiety in young patients. While more research exists on adults, early results for children are encouraging.12345

Who Is on the Research Team?

JO

Jennifer Olson

Principal Investigator

Children's Hospital Colorado

Are You a Good Fit for This Trial?

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.
I am either younger than 4 or older than 17 years old.
See 5 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: WB:UCActive Control1 Intervention
Group II: UC:WBActive Control1 Intervention

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+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40662270/
Effects of Weighted Blankets on Anxiety for Pediatric ...The goal of this work is to assess the effectiveness of weighted blankets in reducing anxiety for pediatric oncology patients. ... data. A ...
Effect of Weighted Blankets on Anxiety for Pediatric ...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.
Effects of Weighted Blankets on Anxiety for Pediatric ...This study indicates that anxiety was reduced during chemotherapy infusions. Multitudes of interventions, such as art therapy and virtual ...
Weighted Blankets Significantly Reduce Anxiety in ...Weighted blankets significantly reduced acute anxiety among pediatric oncology patients following chemotherapy infusion, according to a ...
Effects of Weighted Blankets on Anxiety for Pediatric ...Results: There were 26 participants who were enrolled in the data. Regression models revealed that anxiety scores reduced by -0.71 (95% CI = -1.25 to -0.19 ...
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