Clinical trial NCT06089408: Weighted Blanket Use to Reduce Anxiety in Oncology Patients
Official title: Weighted Blanket Use in Oncology Patients to Reduce Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: Levels of anxiety using State Trait Anxiety Inventory (STAI) for Adults, short form
timeFrame: At baseline and 30 minutes after use of either a standard or weighted blanket
Secondary outcomes:
measure: Levels of distress using NCCN Distress Thermometer
timeFrame: At baseline and 30 minutes after use of either a standard or weighted blanket
measure: 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
timeFrame: At baseline and 30 minutes after use of either a standard or weighted blanket
measure: Qualitative change in levels of distress based on the baseline and 30 min post blanket use scores using NCCN Distress Thermometer
timeFrame: At baseline and 30 minutes after use of either a standard or weighted blanket
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Allison De Villiers, MSN, RN, ONC
role: PRINCIPAL_INVESTIGATOR
References: