Actively Recruiting
RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
Led by VA Office of Research and Development · Updated on 2026-04-24
160
Participants Needed
2
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic pain is a major health concern for returning Veterans and is associated with decreases in quality of life. In addition, chronic pain is often accompanied by significant disturbance in sleep. Sensory interventions may offer effective, low-cost complementary tools for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn with weighted material inside to provide widespread pressure to the body- are a low-cost wellness product used for anxiety and sleep. WBs have demonstrated large reductions in insomnia, and the investigators have also shown that they can reduce the severity of chronic pain. However, effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance. The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators will remotely collect measures of pain (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 home use of the assigned blanket. The investigators will also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence.
CONDITIONS
Official Title
RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrolled in the VA system
- Any gender, aged 18 years or older
- Diagnosed with chronic non-cancer musculoskeletal pain for at least 6 months with pain score of 3 or higher in the past week
- Experiencing sleep disturbance with an Insomnia Severity Index score of 11 or higher
You will not qualify if you...
- Serious or untreated mental illness such as psychosis (PTSD allowed)
- Psychosocial instability like homelessness
- Suicidal or homicidal thoughts or attempts in past 3 years
- Evidence of opioid use disorder or high opioid misuse score
- Major medical conditions or contraindications to using a 15-lb weighted blanket, including pregnancy, claustrophobia, spinal cord injury, or inability to safely lift 15 lb
- Untreated obstructive sleep apnea or high risk on STOP-BANG screening
- Currently sleeping with a special blanket like a weighted or cooling blanket
- Recent or expected changes in mental health or pain treatment within 3 months before or during the trial
AI-Screening
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Trial Site Locations
Total: 2 locations
1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
Actively Recruiting
2
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563
Actively Recruiting
Research Team
I
Irina Strigo, PhD
CONTACT
M
Matthew R Herbert, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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