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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
114
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
RECRUITINGLevels 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.
Time frame: At baseline and 30 minutes after use of either a standard or weighted blanket
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.
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
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.
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
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.
Time frame: At baseline and 30 minutes after use of either a standard or weighted blanket
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