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RECRUITING
NCT05963607
NA

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

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-08-01

Completion Date

2029-09-30

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

OTHER

Weighted blanket

A blanket sewn with extra weight in it.

Locations (3)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States