# RCT of a Weighted Blanket to Reduce Pain in Veterans with Chronic Pain

> **NIH VA I01** · VA SAN DIEGO HEALTHCARE SYSTEM · 2024 · —

## Abstract

Chronic pain is a major health concern for returning Veterans and is associated with decreases in quality of
life. The management of pain, including non-drug approaches, is a high priority for the Veterans Administration
(VA) and VA primary care providers. The long-term goal is to determine the efficacy and mechanism of
clinically useful interventions for chronic pain. Sensory interventions such as widespread pressure may be one
effective approach. In addition to published studies documenting significant effects on anxiety and sleep, our
preliminary data suggest that a Weighted Blanket (WB) is a feasible, low-cost complementary intervention for
chronic pain. In direct response to the CSR&D priority research area “Pain mechanisms and treatments
including alternatives to opioids,” the overall objectives in this application are to determine whether in Veterans
with chronic pain and sleep disturbance, a heavy WB versus light control blanket will reduce (i)
musculoskeletal chronic pain and (ii) sleep disturbance, and (iii) whether improvements in sleep mediate
reductions in pain. Our central hypothesis is that although both study arms will be associated with positive
clinical outcomes, deeper pressure will be associated with greater reductions in pain impact and sleep
disturbance, with changes in sleep mediating changes in pain. The rationale for this project is that determining
the impact of WBs on chronic pain and sleep disturbance is expected to offer novel insights into the efficacy
and mechanism of WBs, informing both mechanistic studies and clinical treatment. Guided by published and
strong preliminary data, our central hypothesis will be tested by pursuing three specific aims: 1) Compare the
efficacy of a WB and control blanket on chronic pain in Veterans with musculoskeletal chronic pain and sleep
disturbance; 2) Compare the efficacy of a WB and control blanket on sleep disturbance in Veterans with
musculoskeletal chronic pain and sleep disturbance; and 3) Examine the mediation effects of sleep on chronic
pain. This will be accomplished by recruiting Veterans with musculoskeletal chronic pain and sleep disturbance
and randomizing 160 Veterans to receive either a heavy (15-lb) or light (3-lb; control) blanket. We will collect
measures of pain impact (primary), pain catastrophizing, and pain medication use, as well as sleep disturbance
(primary) and sleep efficiency and total sleep time over 6 weeks of overnight use of either blanket. Ecological
momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence. The
research proposed here is innovative, because it: 1) leverages recent research on the affective and sensory
effects of deep pressure; 2) tests novel effects of an established intervention for sleep and anxiety; and 3)
utilizes a remote intervention implemented passively during sleep, reducing participant time and effort. The
research proposed in this project is significant since it will identify effects of ...

## Key facts

- **NIH application ID:** 10692309
- **Project number:** 1I01CX002591-01A1
- **Recipient organization:** VA SAN DIEGO HEALTHCARE SYSTEM
- **Principal Investigator:** Laura K Case
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2024
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2023-10-01 → 2028-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10692309

## Citation

> US National Institutes of Health, RePORTER application 10692309, RCT of a Weighted Blanket to Reduce Pain in Veterans with Chronic Pain (1I01CX002591-01A1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10692309. Licensed CC0.

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