An interventional study of Weighted Blanket in Pediatric Cancer, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-06-15.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
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.
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.
1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.
This study's enrollment of 26 is below the median of 64 across 947 interventional studies indexed under Body Weight.
Browse Body Weight studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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Exclusion Criteria:
Weighted Blanket 2nd infusion Usual Care 3rd infusion
Device: Weighted Blanket
Usual Care 2nd infusion Weighted Blanket 3rd infusion
Device: Weighted Blanket
Weighted blankets provide Deep Pressure Stimulation (DPS) or Deep Touch Pressure (DTP) which has advantages in both physical and psychological domains.
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).
Time frame: 12 months
Pediatric Quality of Life Inventory Generic Core Scales (Peds QL 4.0)
The Peds QL 4.0 is a 23-item questionnaire and is broken up into four sections: physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). These questions are aimed to measure health-related quality of life in children and adolescents who are healthy and those with acute or chronic health conditions (Varni, Burwinkle, Seid \& Skarr, 2003). We will utilize the parent-proxy questionnaires with responses measured on a 5-point response scale: 0 = never a problem; 1= almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. The scale is recoded and summarized to have a score ranging from 0 to 100 where higher values indicate higher quality of life.
Time frame: 12 months
Weighted Blanket Use
Prior to discharge, a trained infusion nurse or a member of the weighed blanket research team will ask participants/families to classify if the participant used the blanket 0-20%, 20-40%, 40-60%, 60-80%, or 80-100% of their total infusion time.
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver