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NCT Number: NCT06089408

Weighted Blanket Use to Reduce Anxiety in Oncology Patients

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.

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Key information

Conditions

Hematopoietic and Lymphoid Cell Neoplasm Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Malignant Solid Neoplasm Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Allison De Villiers, MSN, RN, ONC

CONTACT

[email protected]

614-293-7135

Allison De Villiers, MSN, RN, ONC

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Use a regular blanket

Other names: standard of care, standard therapy

Supportive Care

Other

Use a weighted blanket

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. Levels of distress using NCCN Distress Thermometer

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

    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.

  2. 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

    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.

  3. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Weighted Blanket Use in Oncology Patients to Reduce Anxiety

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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