Chronic PainEMBRACENCT07498491
Weighted Blanket Use for Adults With Chronic Pain
A study testing Weighted Blanket in people with Chronic Pain and Musculoskeletal Pain, run by National University of Natural Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain, Sleep Disturbance
- What is being tested?
- Weighted Blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2026to 6 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Willing to undergo study procedures, including completion of online questionnaires and surveys, and attend virtual study visits.
- Informed Consent: Participants must be able to provide informed consent and comply with the study procedure.
- Able to speak, read, and understand English.
- Able to access WIFI to attend virtual visits and complete study surveys.
Who cannot join
- Age: Participants younger than 18 years old.
- Currently using a weighted blanket (will have opportunity for washout period)
- Inability to lift a 10-25 lbs. (10% of body weight) weighted blanket without assistance.
- Inability or unwillingness to sleep with the weighted blanket nightly
- Breathing/Respiratory Issue: Obstructive sleep apnea (OSA), Chronic obstructive Pulmonary Disease (COPD- includes emphysema and chronic bronchitis), Tuberculosis (TB), severe asthma
- Cancer: Lung cancer
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- Cardiovascular Disease: Congestive heart failure (CHF), severe cardiomyopathy
- Circulatory Issues: Severe peripheral artery disease (PAD), severe or uncontrolled Type 2 Diabetes
- Recent surgery: Participants who recently had surgery and/or have an open wound.
- Pregnancy or Lactation: Individuals who are pregnant, lactating, or planning a pregnancy within the next 35 days.
- Co-sleeping: Individuals who co-sleep with their infant or young child.
- Allergies: Known allergy or hypersensitivity to any component of the study products (including cotton material, natural and plant-based dyes).
- Claustrophobia
- Participation in Other Pain Trials: Currently participating in another pain research study.
- Any condition that, in the opinion of the Investigator, does not justify the individuals' participation in the study that may impact their safety or confound trial results. This includes an increase in the participants' pain intensity during the baseline week or the active part of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
National University of Natural Medicine
Portland, Oregon, 97201
About this study
Official title: A Single-Arm Pilot Study Investigating Weighted Blanket Use for Chronic Pain
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.
Read more
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.
Read the detailed 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 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.
- Conditions
- Chronic Pain, Musculoskeletal Pain, Sleep Disturbance, Pain Disorders
- Being tested
- Weighted Blanket
- Keywords
- chronic pain, weighted blanket, pain management, non-pharmacologic pain management, sleep intervention
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain, Parasomnias, Somatoform Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted BlanketDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Weighted Blanket Nightly Use for Chronic Pain | Experimental | 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. Receives: Device: Weighted Blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to end of intervention (approximately 5 weeks)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to end of intervention (approximately 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start27 May 2026
- Primary completion6 Nov 2026 (estimated)
- Study completion6 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a single-arm pilot design in which all enrolled participants receive the same intervention. Adults with chronic pain will receive a weighted blanket sized to approximately 10 percent of their body weight and will be asked 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 enables assessment of tolerability and adherence before continuing in the study. Participants who tolerate the blanket and use it nightly will proceed to the 4-week study phase. Data will be collected using online questionnaires completed at baseline, after the adjustment period, and at the end of the study, along with brief weekly surveys to assess adherence and participant experience. The study will evaluate feasibility, adherence, and participant-reported outcomes related to pain, sleep, and quality of life.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carina Staab, National University of Natural Medicine
- Investigators
- Carina Staab, DC, MEd, Principal investigator, National University of Natural Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498491
- Sponsor's protocol ID
- CS123025
- Acronym
- EMBRACE
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
PubMed 20685078Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, Asch SM, Kroenke K. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009 Jun;24(6):733-8. doi: 10.1007/s11606-009-0981-1. Epub 2009 May 6.
PubMed 19418100Benbir Senel G, Karadeniz D. Interim Analysis of a Prospective Polysomnographic Study of Weighted Blankets in Patients with Psychophysiological Insomnia. Psychiatry Clin Psychopharmacol. 2024 Dec 17;34(4):365-370. doi: 10.5152/pcp.2024.23795.
PubMed 39772300Suri P, Heagerty PJ, Timmons A, Jensen MP. Description and initial validation of a novel measure of pain intensity: the Numeric Rating Scale of Underlying Pain without concurrent Analgesic use. Pain. 2024 Jul 1;165(7):1482-1492. doi: 10.1097/j.pain.0000000000003150. Epub 2024 Jan 2.
PubMed 38189184Baumgartner JN, Quintana D, Leija L, Schuster NM, Bruno KA, Castellanos JP, Case LK. Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial. J Pain. 2022 Jan;23(1):156-174. doi: 10.1016/j.jpain.2021.07.009. Epub 2021 Aug 20.
PubMed 34425251Baumgartner JN, Haupt MR, Case LK. Chronic pain patients low in social connectedness report higher pain and need deeper pressure for pain relief. Emotion. 2023 Dec;23(8):2156-2168. doi: 10.1037/emo0001228. Epub 2023 Mar 30.
PubMed 36996174Yu J, Yang Z, Sun S, Sun K, Chen W, Zhang L, Xu J, Xu Q, Liu Z, Ke J, Zhang L, Zhu Y. The effect of weighted blankets on sleep and related disorders: a brief review. Front Psychiatry. 2024 Apr 15;15:1333015. doi: 10.3389/fpsyt.2024.1333015. eCollection 2024.
PubMed 38686123Ekholm B, Spulber S, Adler M. A randomized controlled study of weighted chain blankets for insomnia in psychiatric disorders. J Clin Sleep Med. 2020 Sep 15;16(9):1567-1577. doi: 10.5664/jcsm.8636.
PubMed 32536366Reynolds S, Lane SJ, Mullen B. Effects of deep pressure stimulation on physiological arousal. Am J Occup Ther. 2015 May-Jun;69(3):6903350010p1-5. doi: 10.5014/ajot.2015.015560.
PubMed 25871605Jain SV, Panjeton GD, Martins YC. Relationship Between Sleep Disturbances and Chronic Pain: A Narrative Review. Clin Pract. 2024 Dec 9;14(6):2650-2660. doi: 10.3390/clinpract14060209.
PubMed 39727797Guy GP Jr, Miller GF, Legha JK, Rikard SM, Strahan AE, Mikosz C, Florence CS. Economic Costs of Chronic Pain-United States, 2021. Med Care. 2025 Sep 1;63(9):679-685. doi: 10.1097/MLR.0000000000002181. Epub 2025 Jul 3.
PubMed 40730349
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Pilot Study Investigating Weighted Blanket Use for Chronic Pain
- ClinicalTrials.gov ID
- NCT07498491
- Acronym / sponsor ID
- EMBRACE / CS123025
- Conditions
- Chronic Pain, Musculoskeletal Pain, Sleep Disturbance, Pain Disorders
- Keywords
- chronic pain, weighted blanket, pain management, non-pharmacologic pain management, sleep intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- 6 Nov 2026 (estimated)
- Study completion
- 6 Nov 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a single-arm pilot design in which all enrolled participants receive the same intervention. Adults with chronic pain will receive a weighted blanket sized to approximately 10 percent of their body weight and will be asked 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 enables assessment of tolerability and adherence before continuing in the study. Participants who tolerate the blanket and use it nightly will proceed to the 4-week study phase. Data will be collected using online questionnaires completed at baseline, after the adjustment period, and at the end of the study, along with brief weekly surveys to assess adherence and participant experience. The study will evaluate feasibility, adherence, and participant-reported outcomes related to pain, sleep, and quality of life.
| Arm | Type | Receives |
|---|---|---|
| Weighted Blanket Nightly Use for Chronic Pain | Experimental | Device: Weighted BlanketParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (15 listed)
- Age: Participants younger than 18 years old.
- Currently using a weighted blanket (will have opportunity for washout period)
- Inability to lift a 10-25 lbs. (10% of body weight) weighted blanket without assistance.
- Inability or unwillingness to sleep with the weighted blanket nightly
- Breathing/Respiratory Issue: Obstructive sleep apnea (OSA), Chronic obstructive Pulmonary Disease (COPD- includes emphysema and chronic bronchitis), Tuberculosis (TB), severe asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted BlanketParticipants 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. | Device | Weighted Blanket Nightly Use for Chronic Pain |
Primary outcome
Change in self-reported pain intensity
Time frame: Baseline to end of intervention (approximately 5 weeks)
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.
9 secondary outcomes
Change in physical function
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in anxiety
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in depression
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in fatigue
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in sleep disturbance
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in ability to participate in social roles and activities
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in pain interference
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in cognitive function
Time frame: Baseline to end of intervention (approximately 5 weeks)
Change in pain intensity
Time frame: Baseline to end of intervention (approximately 5 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 20685078Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
- Background: PubMed 19418100Krebs EE, Lorenz KA, Bair MJ, Damush TM, Wu J, Sutherland JM, Asch SM, Kroenke K. Development and initial validation of the PEG, a three-item scale assessing pain intensity and interference. J Gen Intern Med. 2009 Jun;24(6):733-8. doi: 10.1007/s11606-009-0981-1. Epub 2009 May 6.
- Background: PubMed 39772300Benbir Senel G, Karadeniz D. Interim Analysis of a Prospective Polysomnographic Study of Weighted Blankets in Patients with Psychophysiological Insomnia. Psychiatry Clin Psychopharmacol. 2024 Dec 17;34(4):365-370. doi: 10.5152/pcp.2024.23795.
- Background: PubMed 38189184Suri P, Heagerty PJ, Timmons A, Jensen MP. Description and initial validation of a novel measure of pain intensity: the Numeric Rating Scale of Underlying Pain without concurrent Analgesic use. Pain. 2024 Jul 1;165(7):1482-1492. doi: 10.1097/j.pain.0000000000003150. Epub 2024 Jan 2.
- Background: PubMed 34425251Baumgartner JN, Quintana D, Leija L, Schuster NM, Bruno KA, Castellanos JP, Case LK. Widespread Pressure Delivered by a Weighted Blanket Reduces Chronic Pain: A Randomized Controlled Trial. J Pain. 2022 Jan;23(1):156-174. doi: 10.1016/j.jpain.2021.07.009. Epub 2021 Aug 20.
- Background: PubMed 36996174Baumgartner JN, Haupt MR, Case LK. Chronic pain patients low in social connectedness report higher pain and need deeper pressure for pain relief. Emotion. 2023 Dec;23(8):2156-2168. doi: 10.1037/emo0001228. Epub 2023 Mar 30.
- Background: PubMed 38686123Yu J, Yang Z, Sun S, Sun K, Chen W, Zhang L, Xu J, Xu Q, Liu Z, Ke J, Zhang L, Zhu Y. The effect of weighted blankets on sleep and related disorders: a brief review. Front Psychiatry. 2024 Apr 15;15:1333015. doi: 10.3389/fpsyt.2024.1333015. eCollection 2024.
- Background: PubMed 32536366Ekholm B, Spulber S, Adler M. A randomized controlled study of weighted chain blankets for insomnia in psychiatric disorders. J Clin Sleep Med. 2020 Sep 15;16(9):1567-1577. doi: 10.5664/jcsm.8636.
- Background: PubMed 25871605Reynolds S, Lane SJ, Mullen B. Effects of deep pressure stimulation on physiological arousal. Am J Occup Ther. 2015 May-Jun;69(3):6903350010p1-5. doi: 10.5014/ajot.2015.015560.
- Background: PubMed 39727797Jain SV, Panjeton GD, Martins YC. Relationship Between Sleep Disturbances and Chronic Pain: A Narrative Review. Clin Pract. 2024 Dec 9;14(6):2650-2660. doi: 10.3390/clinpract14060209.
- Background: PubMed 40730349Guy GP Jr, Miller GF, Legha JK, Rikard SM, Strahan AE, Mikosz C, Florence CS. Economic Costs of Chronic Pain-United States, 2021. Med Care. 2025 Sep 1;63(9):679-685. doi: 10.1097/MLR.0000000000002181. Epub 2025 Jul 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carina Staab, DC, MEd principal investigator
National University of Natural Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted Blanket in people with Chronic Pain and Musculoskeletal Pain, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported pain intensity (time frame: Baseline to end of intervention (approximately 5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07498491, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.