RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain

Part of paid clinical trials in San Diego, California.

Sponsor
VA Office of Research and Development
Study ID
NCT05963607
Status
Recruiting
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Conditions

  • Chronic Pain
  • Sleep Disturbance

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Weighted blanket — OTHER
    A blanket sewn with extra weight in it.

Study Details

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.

Key Dates

Start date
Aug 1, 2024
Status verified
Apr 2026
Primary completion
Apr 1, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Heavy blanket
    Wear heavy blanket overnight for 6 weeks
  • Active Comparator: Light blanket
    Wear light blanket overnight for 6 weeks

Primary Outcome Measure

Pain impact change [ Time Frame: Weeks 0, 2, 4, and 6 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161-0002
Jennifer Mitchell, PhD
[email protected]
415-221-4810
Rebecca Yu, BA
[email protected]
4152214810
San Francisco VA Medical Center, San Francisco, CASan FranciscoCalifornia94121-1563
Irina Strigo, PhD
[email protected]
415-221-4810
Rebecca Yu
[email protected]
(415) 221-4810
Irina Strigo, PhD (PRINCIPAL_INVESTIGATOR)

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