Weighted Blanket Use to Reduce Anxiety in Oncology Patients

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06089408
Status
Recruiting
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Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Best Practice — OTHER
    Use a regular blanket
  • Supportive Care — OTHER
    Use a weighted blanket
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
114 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm I (weighted blanket)
    Patients use a weighted blanket for 30 minutes during the infusion appointment.
  • Active Comparator: Arm II (regular blanket)
    Patients use a regular blanket for 30 minutes per standard of care during the infusion appointment.

Primary Outcome Measure

Levels of anxiety using State Trait Anxiety Inventory (STAI) for Adults, short form [ Time Frame: At baseline and 30 minutes after use of either a standard or weighted blanket ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Allison De Villiers, MSN, RN, ONC
[email protected]
614-293-7135
Allison De Villiers, MSN, RN, ONC (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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