Chronic pain is a widespread condition that can significantly affect physical functioning, sleep, emotional well-being, and overall quality of life. Many individuals living with chronic pain seek non-pharmacologic strategies to support symptom management, particularly approaches that may improve sleep and relaxation. Weighted blankets are commercially available products designed to apply gentle, evenly distributed pressure across the body. Although these blankets are widely used to promote comfort and relaxation during sleep, limited research has examined their use among adults with chronic pain.
This study is a single-arm pilot trial designed to explore the feasibility and participant experiences associated with nightly use of a weighted blanket among adults with chronic pain. The study will examine whether regular use of a weighted blanket during sleep is associated with changes in self-reported pain, sleep, and quality of life over a short intervention period. In addition to quantitative survey measures, participant feedback will provide insight into acceptability, adherence, and perceived benefits or challenges related to using a weighted blanket for pain management.
Adults with chronic pain will be recruited to participate in the study. Following eligibility screening and informed consent, participants will complete baseline questionnaires during a virtual enrollment visit. These assessments will include the PEG scale to measure pain intensity and interference, and the PROMIS-29 profile to assess domains of physical function, sleep disturbance, fatigue, anxiety, depression, and pain interference, along with demographic and health-related information.
Participants will receive a weighted blanket sized to approximately 10 percent of their body weight and will be instructed to use the blanket nightly while sleeping. Blanket weight will be assigned based on participant body weight using the following categories: participants weighing 100-149.9 pounds will receive a 10-pound blanket; participants weighing 150-199.9 pounds will receive a 15-pound blanket; participants weighing 200-249.9 pounds will receive a 20-pound blanket; and participants weighing 250-299.9 pounds will receive a 25-pound blanket. Participants will begin with a 7-day adjustment period to become accustomed to the blanket, followed by a 4-week intervention period during which the weighted blanket will be used nightly during sleep.
The active study phase will last four weeks. During this time, participants will be asked to use the weighted blanket nightly while sleeping. Participants will complete brief weekly surveys to report their adherence to using the blanket and share information about their experiences during the study period.
At the conclusion of the study, participants will complete follow-up questionnaires consistent with baseline measures, including the PEG scale and PROMIS-29 profile. These assessments will be used to evaluate changes in pain, sleep, physical function, and quality-of-life domains over the study period. Participants will also complete open-ended survey questions to describe their experiences using the weighted blanket, including any perceived benefits, challenges, or changes in symptoms.
This pilot study is designed to provide preliminary data regarding the acceptability, adherence, and potential effects of weighted blanket use among adults with chronic pain. The findings will help inform the design of future research examining non-medication approaches for chronic pain management and may guide the development of larger controlled studies in this area.
