An interventional study of Weighted Blanket in Chronic Pain, Musculoskeletal Pain and Sleep Disturbance, sponsored by National University of Natural Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by National University of Natural Medicine · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Participants will receive a weighted blanket sized to approximately 10 percent of their body weight and will be instructed to use the blanket nightly during sleep. The study includes a 7-day run-in adjustment period followed by a 4-week intervention period. The run-in period allows participants to become accustomed to the blanket and assess tolerability. Participants who tolerate the blanket will continue using it nightly for the 4-week study phase. Participants will complete questionnaires at baseline, after the run-in period, and at the end of the study, along with brief weekly surveys to report adherence and experiences using the weighted blanket.
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.
Change in self-reported pain intensity
Change in participant-reported pain intensity and interference as measured by the Pain, Enjoyment of Life, and General Activity (PEG) scale. The PEG is a validated 3-item measure assessing average pain intensity, pain interference with enjoyment of life, and pain interference with general activity over the past week, each rated on a 0-10 numeric scale. A composite score is calculated as the mean of the three items, with higher scores indicating greater pain and interference. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes following nightly use of a weighted blanket.
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in physical function
Change in physical function as measured by the PROMIS-29 Physical Function subdomain. This subdomain includes four self-reported items assessing the ability to perform daily activities. Each item is rated on a 5-point scale from 5 (without any difficulty) to 1 (unable to do), with higher scores indicating better physical function. Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating better physical function. T-scores may be interpreted as within normal limits (\>45), mild (40-44), moderate (30-39), or severe (\<30) impairment. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in physical function following nightly use of a weighted blanket.
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in anxiety
Change in anxiety as measured by the PROMIS-29 Anxiety subdomain. This subdomain includes four self-reported items assessing feelings of fear, difficulty focusing due to anxiety, feeling overwhelmed by worry, and general unease over the past 7 days. Each item is rated on a 5-point scale from 1 (never) to 5 (always), with higher scores indicating greater anxiety severity. Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating greater anxiety. T-scores may be interpreted as within normal limits (\<55), mild (55-59), moderate (60-69), or severe (≥70) anxiety. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in anxiety following nightly use of a weighted blanket.
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in depression
Change in depression as measured by the PROMIS-29 Depression subdomain. This subdomain includes four self-reported items assessing feelings of worthlessness, helplessness, depression, and hopelessness over the past 7 days. Each item is rated on a 5-point scale from 1 (never) to 5 (always), with higher scores indicating greater depressive symptoms. Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating greater depression severity. T-scores may be interpreted as within normal limits (\<55), mild (55-59), moderate (60-69), or severe (≥70) depression. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in depressive symptoms following nightly use of a weighted blanket.
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in fatigue
Change in fatigue as measured by the PROMIS-29 Fatigue subdomain. This subdomain includes four self-reported items assessing feelings of fatigue, difficulty initiating activities due to tiredness, feelings of being run-down, and average fatigue over the past 7 days. Each item is rated on a 5-point scale from 1 (not at all) to 5 (very much), with higher scores indicating greater fatigue severity. Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating greater fatigue. T-scores may be interpreted as within normal limits (\<55), mild (55-59), moderate (60-69), or severe (≥70) fatigue. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in fatigue following nightly use of a weighted blanket.
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in sleep disturbance
Change in sleep disturbance as measured by the PROMIS-29 Sleep Disturbance subdomain. This subdomain includes four self-reported items assessing sleep quality, sleep refreshment, overall sleep problems, and difficulty falling asleep over the past 7 days. Sleep quality is rated on a 5-point scale from 1 (very good) to 5 (very poor). Sleep refreshment is rated from 1 (very much) to 5 (not at all). Sleep problems and difficulty falling asleep are rated on a 5-point scale from 1 (not at all) to 5 (very much). Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher scores indicating greater sleep disturbance. T-scores may be interpreted as within normal limits (\<55), mild (55-59), moderate (60-69), or severe (≥70) disturbance. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in sleep disturbance following nightly use of a weighted blanket.
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in ability to participate in social roles and activities
Change in ability to participate in social roles and activities as measured by the PROMIS-29 Ability to Participate in Social Roles and Activities subdomain. This subdomain includes four self-reported items assessing difficulty participating in leisure activities, family activities, work, and activities with friends over the past 7 days. Each item is rated on a 5-point scale from 1 (always) to 5 (never), with higher scores indicating better ability to participate and less difficulty. Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating better functioning. T-scores may be interpreted as within normal limits (\>45), mild (40-44), moderate (30-39), or severe (\<30) impairment. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in social participation following nightly use of a weighted blanket.
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in pain interference
Change in pain interference as measured by the PROMIS-29 Pain Interference subdomain. This subdomain includes four self-reported items assessing the extent to which pain interfered with day-to-day activities, work around the home, participation in social activities, and household chores over the past 7 days. Each item is rated on a 5-point scale from 1 (not at all) to 5 (very much), with higher scores indicating greater pain interference. Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating greater interference from pain. T-scores may be interpreted as within normal limits (\<55), mild (55-59), moderate (60-69), or severe (≥70) pain interference. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in pain interference following nightly use of a weighted blanket.
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in cognitive function
Change in cognitive function as measured by the PROMIS Cognitive Function - Abilities subdomain. This subdomain includes self-reported items assessing the ability to concentrate and the ability to remember to complete tasks over the past 7 days. Each item is rated on a 5-point scale from 1 (not at all) to 5 (very much), with higher scores indicating better cognitive functioning. Raw scores are summed and converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating better cognitive abilities. T-scores may be interpreted as within normal limits (\>45), mild (40-44), moderate (30-39), or severe (\<30) impairment. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in cognitive function following nightly use of a weighted blanket.
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in pain intensity
Change in pain intensity as measured by the PROMIS Pain Intensity subdomain. This measure includes a single self-reported item assessing average pain over the past 7 days. Pain intensity is rated on an 11-point numeric rating scale from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating greater pain intensity. Scores may be reported as raw values or converted to standardized T-scores (mean = 50, standard deviation = 10), with higher T-scores indicating greater pain severity. Assessments will be administered via online surveys at baseline and at the end of the study, and scores will be compared to evaluate changes in pain intensity following nightly use of a weighted blanket.
Time frame: Baseline to end of intervention (approximately 5 weeks)
Participant adherence to weighted blanket use
Participants will complete brief weekly surveys reporting how consistently they used the weighted blanket during sleep. Responses will be used to assess adherence to the nightly intervention.
Time frame: Weekly during the 4-week intervention period
Participant experience with weighted blanket use
Participants will complete open-ended survey questions describing their experiences using the weighted blanket, including perceived benefits, challenges, and overall acceptability of the intervention.
Time frame: End of study (approximately 5 weeks)
Plan to share: No
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