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Weighted Blankets for Cancer Anxiety
N/A
Recruiting
Led By Allison De Villiers, MSN, RN, ONC
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years of age and older
About to begin either targeted or cytotoxic chemotherapy
Must not have
Non-English speaking
Peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 30 minutes after use of either a standard or weighted blanket
Awards & highlights
No Placebo-Only Group
Summary
This trial studies if weighted blankets can reduce anxiety and distress during 1st time cancer treatments. Benefits include feeling safe, comforted, and grounded. Deep touch pressure can reduce stress and increase well-being.
Who is the study for?
This trial is for adult cancer patients starting chemotherapy or immunotherapy who can understand and sign a consent form. It's not for those already using weighted blankets, under 45 kg, with certain conditions like fibromyalgia or claustrophobia, non-English speakers, or those with open wounds from recent surgery.
What is being tested?
The study tests if using weighted blankets during first-time infusions can reduce anxiety compared to regular blankets. Patients' feelings of safety and comfort are measured through surveys to see if the deep touch pressure from the blanket provides a calming effect.
What are the potential side effects?
There may be no direct side effects from using a weighted blanket; however, individuals might experience discomfort due to personal preferences or specific health conditions like claustrophobia or peripheral neuropathy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am starting chemotherapy soon.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not speak English.
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I have nerve damage in my hands or feet.
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I have been diagnosed with fibromyalgia.
Select...
My weight is 45 kg or less.
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I recently had surgery involving a flap of tissue.
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I have an open sore due to prolonged pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and 30 minutes after use of either a standard or weighted blanket
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and 30 minutes after use of either a standard or weighted blanket
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Levels of anxiety using State Trait Anxiety Inventory (STAI) for Adults, short form
Secondary study objectives
Levels of distress using NCCN Distress Thermometer
Qualitative change in levels of anxiety based on the baseline and 30 min post blanket use scores using State Trait Anxiety Inventory (STAI) for Adults, short form
Qualitative change in levels of distress based on the baseline and 30 min post blanket use scores using NCCN Distress Thermometer
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (weighted blanket)Experimental Treatment2 Interventions
Patients use a weighted blanket for 30 minutes during the infusion appointment.
Group II: Arm II (regular blanket)Active Control2 Interventions
Patients use a regular blanket for 30 minutes per standard of care during the infusion appointment.
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
342 Previous Clinical Trials
293,093 Total Patients Enrolled
Allison De Villiers, MSN, RN, ONCPrincipal InvestigatorOhio State University Comprehensive Cancer Center