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Recruiting NCT06089408

Weighted Blanket Use to Reduce Anxiety in Oncology Patients

No phase Interventional Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Best Practice, Supportive Care, Survey Administration.
Who it may be relevant to
Registry conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Weighted Blanket Use in Oncology Patients to Reduce Anxiety

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Levels of distress using NCCN Distress Thermometer [Time frame: At baseline and 30 minutes after use of either a standard or weighted blanket]
  • Qualitative change in levels of anxiety based on the baseline and 30 min post blanket use scores 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]
  • Qualitative change in levels of distress based on the baseline and 30 min post blanket use scores using NCCN Distress Thermometer [Time frame: At baseline and 30 minutes after use of either a standard or weighted blanket]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT06089408 · OSU-22313 · NCI-2023-06974

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗