Effect of Weighted Blankets on Anxiety for Pediatric Oncology Patients

NCT05041075 | Completed

• 1 other identifier: 21-3150.cc
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• Children's Anxiety Meter-State (CAM-S) assessment

  The CAM-S is completed by showing the child a picture of a mercury thermometer and asking the child to "Pretend that all of your worried or nervous feelings are in the very bottom down here (point to scale). If you are a little bit worried or nervous, the feelings might come up just a little bit (move finger up). If you are very, very worried, or nervous, the feelings might come up just a little bit (move finger up to the top). Put a line showing how much worry or nervousness you feel right now." This scale is from measured from 1-10. Higher values indicate higher anxiety. The CAM-S will be administered during the following times: prior to infusion start, thirty minutes into the treatment or end of the treatment if \<30 minutes and end of the treatment (see Figure 1).

  12 months

Secondary Outcomes (1)

• Pediatric Quality of Life Inventory Generic Core Scales (Peds QL 4.0)

  12 months

Other Outcomes (1)

• Weighted Blanket Use

  12 months

Study Arms (2)

WB:UC

ACTIVE COMPARATOR

Weighted Blanket 2nd infusion Usual Care 3rd infusion

Device: Weighted Blanket

UC:WB

ACTIVE COMPARATOR

Usual Care 2nd infusion Weighted Blanket 3rd infusion

Device: Weighted Blanket

Interventions

Weighted Blanket DEVICE

Weighted blankets provide Deep Pressure Stimulation (DPS) or Deep Touch Pressure (DTP) which has advantages in both physical and psychological domains.

UC:WB; WB:UC

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newly diagnosed pediatric oncology patients between the ages of 4 and 17 receiving outpatient chemotherapy infusions in one of the two designated out patient locations (Anschutz Campus and Colorado Springs Hospital)
• Patients who have a "liquid tumor" (leukemia or lymphoma), "solid tumor", or a neuro-oncologic diagnosis
• Patients who can complete the CAM-S and CAM-T as proven by seriation screening.
• Patients who are great than 13.5kg in weight, due to weighted blanket size options
• Patients whose second and third outpatient chemotherapy occur within 30 days of each other.
• English and Spanish speaking

You may not qualify if:

• Patients who are younger than 4 years of age, or older than 17 years of age
• Relapsed patients
• Patients who are undergoing bone marrow transplant or had a previous bone marrow transplant
• Patients receiving chemotherapy infusions at North Campus and South Campus locations
• Patients in the inpatient setting
• Patients who utilize a weighted blanket at home currently or previously
• Patients who fail seriation screening during enrollment
• Patients who start initial chemotherapy infusions in the outpatient setting

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jennifer Olson

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 10, 2021
• Study Start: January 10, 2022
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)