Weighted Blanket Use to Reduce Anxiety in Oncology Patients

NCT06089408 | Recruiting DMC

• 2 other identifiers: OSU-22313NCI-2023-06974
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Levels of anxiety using State Trait Anxiety Inventory (STAI) for Adults, short form

  To test for the effect of the weighted blanket, will fit a mixed model with the post-level of anxiety as the dependent variable and baseline values and treatment (standard or weighted blanket) as predictors. A random effect for patient will be fit to account for the possible correlation of within-patient repeated outcome measures. The models will control for patient gender and age.

  At baseline and 30 minutes after use of either a standard or weighted blanket

Secondary Outcomes (3)

• Levels of distress using NCCN Distress Thermometer

  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

  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

  At baseline and 30 minutes after use of either a standard or weighted blanket

Study Arms (2)

Arm I (weighted blanket)

EXPERIMENTAL

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

Other: Supportive Care; Other: Survey Administration

Arm II (regular blanket)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Survey Administration

Interventions

Best Practice OTHER

Use a regular blanket

Also known as: standard of care, standard therapy

Arm II (regular blanket)

Supportive Care OTHER

Use a weighted blanket

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Arm I (weighted blanket)

Survey Administration OTHER

Ancillary studies

Arm I (weighted blanket); Arm II (regular blanket)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Allison De Villiers, MSN, RN, ONC

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 18, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)