RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain (NCT05963607)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: VA San Diego Healthcare System, San Diego, CA — San Diego, California
Age range: 18 Years
🧪 Interventions in This Study
- Weighted blanket (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- VA San Diego Healthcare System, San Diego, CA — San Diego, California
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California
📞 Contact the Study Coordinator
Phone: (415) 221-4810
Email: irina.strigo@va.gov
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Chronic Pain
- Chronic Pain Management In Primary Care Using Behavioral Health Consultants — Bethesda, Maryland
- Virtual Reality Treatment for Adults With Chronic Back Pain (VRNT) — Boulder, Colorado
- The Effect of Light Therapy on Chronic Pain — Tucson, Arizona
- Jazz Music and Mindfulness for Chronic Pain — Irvine, California
- Improving Pain Management Via Spinal Cord Stimulation and Blood Pressure Reduction — Kansas City, Kansas
- Retrospective PNS Study — Denver, Colorado
Explore by condition: All Chronic Pain clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.