Pediatric CancerNCT05041075
Effect of Weighted Blankets on Anxiety for Pediatric Oncology Patients
A study testing Weighted Blanket in people with Pediatric Cancer, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Weighted Blanket
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Effects of Weighted Blankets on Anxiety for Pediatric Oncology Patients During Outpatient Chemotherapy Infusion
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.
Read the 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
- Being tested
- Weighted Blanket
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted BlanketDevice
Weighted blankets provide Deep Pressure Stimulation (DPS) or Deep Touch Pressure (DTP) which has advantages in both physical and psychological domains.
| Study group | Role | What they receive |
|---|---|---|
| WB:UC | Active comparator | Weighted Blanket 2nd infusion Usual Care 3rd infusion Receives: Device: Weighted Blanket |
| UC:WB | Active comparator | Usual Care 2nd infusion Weighted Blanket 3rd infusion Receives: Device: Weighted Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start10 Jan 2022
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Jennifer Olson, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041075
- Sponsor's protocol ID
- 21-3150.cc
- Status last verified
- Jun 2025
- First submitted
- 7 Sep 2021
- Last updated
- 15 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Weighted Blankets on Anxiety for Pediatric Oncology Patients During Outpatient Chemotherapy Infusion
- ClinicalTrials.gov ID
- NCT05041075
- Acronym / sponsor ID
- 21-3150.cc
- Conditions
- Pediatric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WB:UC | Active comparator | Device: Weighted BlanketWeighted Blanket 2nd infusion Usual Care 3rd infusion |
| UC:WB | Active comparator | Device: Weighted BlanketUsual Care 2nd infusion Weighted Blanket 3rd infusion |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted BlanketWeighted blankets provide Deep Pressure Stimulation (DPS) or Deep Touch Pressure (DTP) which has advantages in both physical and psychological domains. | Device | UC:WB, WB:UC |
Primary outcome
Children's Anxiety Meter-State (CAM-S) assessment
Time frame: 12 months
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).
1 secondary outcome
Pediatric Quality of Life Inventory Generic Core Scales (Peds QL 4.0)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Olson principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted Blanket in people with Pediatric Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Anxiety Meter-State (CAM-S) assessment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.