Weighted Blanket Use to Reduce Anxiety in Oncology Patients

The Ohio State University

Status: Enrolling

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Treatments: Other: Survey Administration; Other: Supportive Care; Other: Best Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT06089408

OSU-22313

NCI-2023-06974 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Arm I (weighted blanket)

Experimental group

Description:

Patients use a weighted blanket for 30 minutes during the infusion appointment.

Treatment:

Other: Supportive Care

Other: Survey Administration

Arm II (regular blanket)

Active Comparator group

Description:

Patients use a regular blanket for 30 minutes per standard of care during the infusion appointment.

Treatment:

Other: Best Practice

Other: Survey Administration