Weighted Blanket Use to Reduce Anxiety in Oncology Patients

Weighted Blanket Use in Oncology Patients to Reduce Anxiety

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: Supportive Care; Other: Best Practice

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.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Allison De Villiers, MSN, RN, ONC; Phone Number: 614-293-7135; Email: allison.devilliers@osumc.edu
      • Principal Investigator: Allison De Villiers, MSN, RN, ONC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (weighted blanket); Patients use a weighted blanket for 30 minutes during the infusion appointment.	Other: Survey Administration; Ancillary studies; Other: Supportive Care; Use a weighted blanket; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive
Active Comparator: Arm II (regular blanket); Patients use a regular blanket for 30 minutes per standard of care during the infusion appointment.	Other: Survey Administration; Ancillary studies; Other: Best Practice; Use a regular blanket; Other Names: standard of care; standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of distress using NCCN Distress Thermometer	To test for the effect of the weighted blanket, will fit a mixed model with the post-level of distress 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
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	Will be binned to create ordinal variables. If they lead to an adequate sample size in each group, clinically relevant cut points will be used for binning. Otherwise, we will bin using outcome medians or terciles, with the choice depending on the distribution of the data collected after blanket use. The categorical representation will be modeled using generalized linear mixed modeling. We will fit ordinal logistic regression models with repeated measures. As with the linear mixed models, baseline values and treatment (standard or weighted blanket) will be predictors, with patient gender and age as control variables.	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	Will be binned to create ordinal variables. If they lead to an adequate sample size in each group, clinically relevant cut points will be used for binning. Otherwise, we will bin using outcome medians or terciles, with the choice depending on the distribution of the data collected after blanket use. The categorical representation will be modeled using generalized linear mixed modeling. We will fit ordinal logistic regression models with repeated measures. As with the linear mixed models, baseline values and treatment (standard or weighted blanket) will be predictors, with patient gender and age as control variables.	At baseline and 30 minutes after use of either a standard or weighted blanket

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Allison De Villiers, MSN, RN, ONC, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: OSU-22313; NCI-2023-06974 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No