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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ The inclusion/exclusion criteria are designed to be as inclusive as possible and to reflect the heterogeneity of real-world Veterans referred to usual care, to maximize generalizability:

• VA-enrolled

• All genders, ages 18 and older

• chronic non-cancer musculoskeletal pain diagnosis on 2 clinical visits for at least 6 months (ICD codes for chronic pain), and a score of 3 on the numerical pain rating scale from 0-10 over the past week

• sleep disturbance measured by a score \>= 11 on the ISI.

Locations
United States
California
VA San Diego Healthcare System, San Diego, CA
RECRUITING
San Diego
VA San Diego Healthcare System, San Diego, CA
RECRUITING
San Diego
San Francisco VA Medical Center, San Francisco, CA
RECRUITING
San Francisco
Contact Information
Primary
Irina Strigo, PhD
irina.strigo@va.gov
(415) 221-4810
Backup
Matthew R Herbert, PhD
matthew.herbert2@va.gov
(858) 642-3944
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 160
Treatments
Experimental: Heavy blanket
Wear heavy blanket overnight for 6 weeks
Active_comparator: Light blanket
Wear light blanket overnight for 6 weeks
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov