Clinical trial · Interventional
Effect of Weighted Blankets on Anxiety for Pediatric Oncology Patients
Effects of Weighted Blankets on Anxiety for Pediatric Oncology Patients During Outpatient Chemotherapy Infusion
NCT05041075CI-TRIAL-00091041completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Weighted Blanket | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- WB:UC
- description
- Weighted Blanket 2nd infusion Usual Care 3rd infusion
- interventionNames
- Device: Weighted Blanket
- type
- ACTIVE_COMPARATOR
- label
- UC:WB
- description
- Usual Care 2nd infusion Weighted Blanket 3rd infusion
- interventionNames
- Device: Weighted Blanket
Primary outcomes (1)
- measure
- Children's Anxiety Meter-State (CAM-S) assessment
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.