Weighted Blankets and Chronic Pain

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

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-04

Study Completion Date

2020-11-25

Brief Summary

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The purpose of the study is to test whether the use of weighted blankets can change the experience of chronic pain and to examine if social, psychological, or health factors influence the perception of the blanket. Multiple blanket weights will be tested.

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Detailed Description

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Conditions

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Chronic Pain Chronic Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental blanket

This blanket is the weight being tested which cannot be disclosed without unblinding participants.

Group Type EXPERIMENTAL

weighted blanket

Intervention Type DEVICE

A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.

Control blanket

This blanket is the control weight which cannot be disclosed without unblinding participants.

Group Type ACTIVE_COMPARATOR

weighted blanket

Intervention Type DEVICE

A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.

Interventions

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weighted blanket

A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 18 years or older
2. Fluent in English
3. Diagnosis of chronic pain (self-report; those already indicating this diagnosis on researchmatch.org)
4. Willing to sleep with a weighted blanket and fitness watch for 1 week
5. Able to safely lift up to 15lb
6. Willing and able to use their personal smartphone for fitness tracker app and EMA app to submit ratings using personal data plan

Exclusion Criteria

1. Pregnancy
2. Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder)
3. Current or previous use of a weighted blanket
4. Claustrophobia

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No