A Single-Arm Pilot Study Investigating Weighted Blanket Use for Chronic Pain

National University of Natural Medicine

Summary

Chronic pain is a common condition that can affect sleep, daily functioning, and overall quality of life. Many individuals living with chronic pain seek non-medication approaches to help manage their symptoms. Weighted blankets are commonly used to promote relaxation and comfort during sleep, but there is limited research examining their potential role in supporting people with chronic pain. This pilot study will explore the experiences of adults with chronic pain who use a weighted blanket during sleep. The study aims to better understand whether nightly use of a weighted blanket may be associated with changes in pain, sleep, and daily functioning. Findings from this study will help inform future research on non-medication approaches to managing chronic pain. Approximately 44 adults with chronic pain will participate in the study. Participation will last about five weeks. After completing a virtual enrollment visit and baseline questionnaires, participants will receive a weighted blanket sized to approximately 10 percent of their body weight. Participants will first complete a 7-day adjustment period using the blanket while sleeping. If they tolerate the blanket and use it nightly during this period, they will continue into a 4-week study phase in which they will use the weighted blanket each night. During the study, participants will complete brief online surveys about their experiences and adherence to using the blanket. Pain and quality-of-life questionnaires will be completed at multiple time points, including at the start and end of the study. Participants will also provide feedback about their experience using the weighted blanket. Results from this pilot study will help researchers better understand how weighted blankets may be used by adults with chronic pain and may help guide the design of future studies evaluating non-pharmacologic approaches to pain management.

Description

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 pa…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Age: Male and non-pregnant female adult participants must 18 years of age or older * Duration of pain: at least 3 months * Average Pain Intensity over the past week: ≥3/10 NRS * Safely able to lift a weighted blanket that is 10% of the participant's self-reported body weight (10-25 lbs.) without assistance. * Willing to sleep with a weighted blanket (10-25 lbs.) for a total of 35 (7 days for Run-In/Adjustment + 28 days of trial). * Willing to maintain current dietary patterns, activity level, and stable body weight for the duration of the study. * Willing to undergo stud…

Interventions

Device
Weighted Blanket
Participants will receive a weighted blanket sized to approximately 10 percent of their body weight for nightly use during sleep. Blanket weight will be assigned by body weight: 10 lb (100-149.9 lbs), 15 lb (150-199.9 lbs), 20 lb (200-249.9 lbs), and 25 lb (250-299.9 lbs). The blanket provides evenly distributed deep pressure across the body through weighted filling materials sewn into the fabric. Participants will begin with a 7-day run-in adjustment period to become accustomed to sleeping with the blanket and to assess tolerability. Those who tolerate the blanket will continue nightly use during a 4-week intervention period. The weighted blanket is intended to provide gentle pressure stimulation during sleep and is being evaluated as a non-pharmacologic approach that may support relaxation, sleep quality, and overall comfort in adults living with chronic pain.

Location

National University of Natural Medicine
Portland, Oregon
cstaab@nunm.edu 503-552-1862

Summary

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

Detailed criteria

Interventions

Device

Weighted Blanket

Participants will receive a weighted blanket sized to approximately 10 percent of their body weight for nightly use during sleep. Blanket weight will be assigned by body weight: 10 lb (100-149.9 lbs), 15 lb (150-199.9 lbs), 20 lb (200-249.9 lbs), and 25 lb (250-299.9 lbs). The blanket provides evenly distributed deep pressure across the body through weighted filling materials sewn into the fabric. Participants will begin with a 7-day run-in adjustment period to become accustomed to sleeping with the blanket and to assess tolerability. Those who tolerate the blanket will continue nightly use during a 4-week intervention period. The weighted blanket is intended to provide gentle pressure stimulation during sleep and is being evaluated as a non-pharmacologic approach that may support relaxation, sleep quality, and overall comfort in adults living with chronic pain.