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Trial Title:
Weighted Blanket Use to Reduce Anxiety in Oncology Patients
NCT ID:
NCT06089408
Condition:
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Use a regular blanket
Arm group label:
Arm II (regular blanket)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Supportive Care
Description:
Use a weighted blanket
Arm group label:
Arm I (weighted blanket)
Other name:
Supportive Therapy
Other name:
Symptom Management
Other name:
Therapy, Supportive
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm I (weighted blanket)
Arm group label:
Arm II (regular blanket)
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.
Detailed description:
PRIMARY OBJECTIVE:
I. To assess the efficacy of weighted blankets on anxiety in patients receiving infusion
therapy.
SECONDARY OBJECTIVE:
I. To assess the efficacy of weighted blankets on distress in patients receiving infusion
therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients use a weighted blanket for 30 minutes during the infusion appointment.
ARM II: Patients use a regular blanket for 30 minutes per standard of care during the
infusion appointment.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Allison De Villiers, MSN, RN, ONC
Phone:
614-293-7135
Email:
allison.devilliers@osumc.edu
Contact backup:
Last name:
Allison De Villiers, MSN, RN, ONC
Start date:
August 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06089408
http://cancer.osu.edu
