NCT05041075

Effect of Weighted Blankets on Anxiety for Pediatric Oncology Patients

Effects of Weighted Blankets on Anxiety for Pediatric Oncology Patients During Outpatient Chemotherapy Infusion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A randomized 2x2 cross-over design will be utilized for this study. The study team will randomize participants to one of two sequences: 1) weighted blanket first then usual care or 2) usual care first then weighted blanket. The cross-over design allows the researchers to compare both within and between group differences. The advantages of the cross-over design allow minimize potential confounding bias as patients will serve as their own controls as well as potential for adequate power with smaller patient enrollment. As this study is conducted during chemotherapy treatments, the 30-day period in between patient treatments will be considered the washout period. This timeframe between chemotherapy infusions was chosen to try to capture patients in a similar state of baseline anxiety. This helps to provide adjustments to variability but should not limit accrual based on the number of patients that get chemotherapy within a 30-day period.

Conditions

• Pediatric Cancer

Interventions

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

Timeline

• Start date: 2022-01-10
• Primary completion: 2023-07-25
• Completion: 2023-07-25
• First posted: 2021-09-10
• Last updated: 2025-06-15

Locations

1 site across 1 country: United States