Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05041075
Study type Interventional
Source University of Colorado, Denver
Contact Barbara Shepperd
Phone 7207776819
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date December 2021
Completion date May 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Enrolling by invitation NCT04719416 - Relaxation Therapy in Pediatric Oncology N/A
Recruiting NCT04257058 - Education Tools to Support Pediatric Survivor Care N/A
Not yet recruiting NCT04614662 - Symptom Screening Linked to Care Pathways Phase 3
Completed NCT01645436 - Physical Activity in Pediatric Cancer (PAPEC) N/A
Recruiting NCT04409301 - Distress in the Pediatric Oncology Setting: Intervention Versus Natural Adaptation N/A
Not yet recruiting NCT04508400 - Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients Phase 2
Not yet recruiting NCT04855487 - Nurse-Adolescent/Young Adult With Cancer Dyadic Storytelling Intervention N/A
Recruiting NCT03241251 - Screening for Psychosocial Risk in Flemish Families of a Child With Cancer
Completed NCT04586491 - The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients N/A
Completed NCT02665819 - Long Term Support for Pediatric Cancer Adult Survivors in Rhône-Alpes : Evaluation of Women Fertility. N/A
Completed NCT02675166 - Getting Long-term Management of Adult Children Cured of Childhood Cancer in Rhône-Alpes
Recruiting NCT02536183 - A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors Phase 1
Withdrawn NCT01828502 - Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer Phase 2
Completed NCT02032121 - Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors N/A
Recruiting NCT03964259 - Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia Phase 1
Enrolling by invitation NCT04150120 - eHealth as an Aid for Facilitating and Supporting Self-management in Families With Long-term Childhood Illness N/A
Recruiting NCT04547829 - Safety and Efficacy of PEG-rhG-CSF in Preventing Neutropenia in Children With Tumor After Chemotherapy Phase 2
Not yet recruiting NCT05024929 - Targeted Therapy to Increase RAI Uptake in Metastatic PTC
Recruiting NCT04479514 - Preventative Skin Care for Children Undergoing Targeted CNS Tumor Therapy Phase 2