Recruiting

Weighted Blanket

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06089408

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Supportive Care

Survey Administration

Study Details

Brief 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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Solid Neoplasm

Study ID

NCT06089408

Start date

Aug 1, 2023

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

114 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Best Practice

Use a regular blanket

Supportive Care

Use a weighted blanket

Survey Administration

Ancillary studies

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 and Locations

Central contacts

The Ohio State Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Allison De Villiers, MSN, RN, ONC

614-293-7135allison.devilliers@osumc.edu

Principal Investigator:

Allison De Villiers, MSN, RN, ONC

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-08-05.