Weighted Blanket Use to Reduce Anxiety in Oncology Patients (NCT06089408) | Clinical Trial Compass
RecruitingNot Applicable
Weighted Blanket Use to Reduce Anxiety in Oncology Patients
United States114 participantsStarted 2023-08-01
Plain-language summary
This clinical trial compares the effect of using weighted blankets versus regular blankets during first time infusions (e.g. chemotherapy, targeted therapy etc.) to decrease adverse side effects such as anxiety and distress in cancer (oncology) patients. Feeling safe, comforted, and grounded in the world are some of the benefits noted by individuals who use weighted blankets. Deep touch pressure (DTP) has been found to reduce symptoms of stress and anxiety and is defined as a sensation one feels when being hugged, squeezed, or held. DTP affects the nervous system by creating a calming effect which may lower stress and increase feelings of well-being. The use of weighted blankets may help to manage anxiety and distress during chemotherapy or immunotherapy infusions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years of age and older
* About to begin either targeted or cytotoxic chemotherapy
* Able to comprehend and sign a consent form
* Able to read and complete surveys
* Alert and oriented
Exclusion Criteria:
* Currently using a weighted blanket at home
* Non-English speaking
* Peripheral neuropathy
* Fibromyalgia
* Open pressure ulcer
* Recent surgical flap
* Claustrophobic
* Weight 45 kg or less
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Given that this study is looking at whether weighted blankets can reduce anxiety during cancer treatment, and my own anxiety levels are a real concern for me, do you think participating in this kind of comfort-focused trial makes sense alongside my main treatment plan?
2This trial measures anxiety using something called the State Trait Anxiety Inventory — can you explain what that assessment involves and how my results would actually be used during the study?
3Since this is a Phase NA or non-drug study involving a weighted blanket rather than a medication or procedure, are there any risks specific to my diagnosis — like my blood cancer or solid tumor — that might make using a weighted blanket during treatment unsafe or uncomfortable for me?
4Would joining this trial affect my regular oncology care in any way, or would it run completely alongside whatever treatment you're already recommending for me?
5Are there other anxiety management options — like counseling, medication, or mindfulness programs — already available through your practice that I should compare this trial against before deciding whether to pursue it?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Levels of anxiety using State Trait Anxiety Inventory (STAI) for Adults, short form
Timeframe: At baseline and 30 minutes after use of either a standard or weighted blanket
Trial details
NCT IDNCT06089408
SponsorOhio State University Comprehensive Cancer Center