Weighted Blanket Use to Reduce Anxiety in Oncology Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I (weighted blanket)

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

Group Type EXPERIMENTAL

Supportive Care

Intervention Type OTHER

Use a weighted blanket

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm II (regular blanket)

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

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Use a regular blanket

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Use a regular blanket

Intervention Type OTHER

Supportive Care

Use a weighted blanket

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Supportive Therapy Symptom Management Therapy, Supportive

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No