Effect of Weighted Blankets on Anxiety for Pediatric Oncology Patients

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05041075
• Other study ID #: 21-3150.cc
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: May 2025

Study information

• Verified date: August 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: May 2025
• Est. primary completion date: August 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Pediatric Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	12 months
Primary	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	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.	12 months