[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07498491":3,"trial-entities:NCT07498491":170,"trial-summary:NCT07498491":173},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":43,"secondary_outcomes":48,"sex":76,"minimum_age":77,"maximum_age":78,"healthy_volunteers":15,"eligibility_criteria":79,"std_ages":108,"locations":111,"central_contacts":126,"overall_officials":131,"references":134,"see_also_links":169},"NCT07498491","CS123025","Weighted Blanket Use for Adults With Chronic Pain","A Single-Arm Pilot Study Investigating Weighted Blanket Use for Chronic Pain","RECRUITING","2026-09-15","2026-06","2026-06-17","2026-05-27","National University of Natural Medicine","OTHER",false,"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.\n\nThis 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.\n\nApproximately 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.\n\nParticipants 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.\n\nDuring 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.\n\nResults 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.\n\nThis 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.\n\nAdults 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.\n\nParticipants 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.\n\nThe 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.\n\nAt 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.\n\nThis 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.",[19,20,21,22],"Chronic Pain","Musculoskeletal Pain","Sleep Disturbance","Pain Disorders",[24,25,26,27,28],"chronic pain","weighted blanket","pain management","non-pharmacologic pain management","sleep intervention","INTERVENTIONAL","TREATMENT",[32],"NA",{"count":34,"type":35},44,"ESTIMATED",[37],{"type":38,"name":39,"description":40,"armGroupLabels":41},"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.",[42],"Weighted Blanket Nightly Use for Chronic Pain",[44],{"measure":45,"description":46,"timeFrame":47},"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.","Baseline to end of intervention (approximately 5 weeks)",[49,52,55,58,61,64,67,70,73],{"measure":50,"description":51,"timeFrame":47},"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 (\\\u003C30) 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.",{"measure":53,"description":54,"timeFrame":47},"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 (\\\u003C55), 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.",{"measure":56,"description":57,"timeFrame":47},"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 (\\\u003C55), 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.",{"measure":59,"description":60,"timeFrame":47},"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 (\\\u003C55), 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.",{"measure":62,"description":63,"timeFrame":47},"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 (\\\u003C55), 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.",{"measure":65,"description":66,"timeFrame":47},"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 (\\\u003C30) 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.",{"measure":68,"description":69,"timeFrame":47},"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 (\\\u003C55), 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.",{"measure":71,"description":72,"timeFrame":47},"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 (\\\u003C30) 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.",{"measure":74,"description":75,"timeFrame":47},"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.","ALL","18 Years",null,{"inclusion":80,"exclusion":91,"raw_text":107},[81,82,83,84,85,86,87,88,89,90],"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\u002F10 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\u002FAdjustment + 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 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.",[92,93,94,95,96,97,98,99,100,101,102,103,104,105,106],"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\u002FRespiratory Issue: Obstructive sleep apnea (OSA), Chronic obstructive Pulmonary Disease (COPD- includes emphysema and chronic bronchitis), Tuberculosis (TB), severe asthma","Cancer: Lung cancer","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\u002For 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.","Inclusion Criteria:\n\n* Age: Male and non-pregnant female adult participants must 18 years of age or older\n* Duration of pain: at least 3 months\n* Average Pain Intensity over the past week: ≥3\u002F10 NRS\n* Safely able to lift a weighted blanket that is 10% of the participant's self-reported body weight (10-25 lbs.) without assistance.\n* Willing to sleep with a weighted blanket (10-25 lbs.) for a total of 35 (7 days for Run-In\u002FAdjustment + 28 days of trial).\n* Willing to maintain current dietary patterns, activity level, and stable body weight for the duration of the study.\n* Willing to undergo study procedures, including completion of online questionnaires and surveys, and attend virtual study visits.\n* Informed Consent: Participants must be able to provide informed consent and comply with the study procedure.\n* Able to speak, read, and understand English.\n* Able to access WIFI to attend virtual visits and complete study surveys.\n\nExclusion Criteria:\n\n* Age: Participants younger than 18 years old.\n* Currently using a weighted blanket (will have opportunity for washout period)\n* Inability to lift a 10-25 lbs. (10% of body weight) weighted blanket without assistance.\n* Inability or unwillingness to sleep with the weighted blanket nightly\n* Breathing\u002FRespiratory Issue: Obstructive sleep apnea (OSA), Chronic obstructive Pulmonary Disease (COPD- includes emphysema and chronic bronchitis), Tuberculosis (TB), severe asthma\n* Cancer: Lung cancer\n* Cardiovascular Disease: Congestive heart failure (CHF), severe cardiomyopathy\n* Circulatory Issues: Severe peripheral artery disease (PAD), severe or uncontrolled Type 2 Diabetes\n* Recent surgery: Participants who recently had surgery and\u002For have an open wound.\n* Pregnancy or Lactation: Individuals who are pregnant, lactating, or planning a pregnancy within the next 35 days.\n* Co-sleeping: Individuals who co-sleep with their infant or young child.\n* Allergies: Known allergy or hypersensitivity to any component of the study products (including cotton material, natural and plant-based dyes).\n* Claustrophobia\n* Participation in Other Pain Trials: Currently participating in another pain research study.\n* 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.",[109,110],"ADULT","OLDER_ADULT",[112],{"facility":13,"status":8,"city":113,"state":114,"zip":115,"country":116,"contacts":117,"geoPoint":123},"Portland","Oregon","97201","United States",[118],{"name":119,"role":120,"phone":121,"email":122},"Carina Staab, DC, MEd","CONTACT","503-552-1862","cstaab@nunm.edu",{"lat":124,"lon":125},45.52345,-122.67621,[127,128],{"name":119,"role":120,"phone":121,"email":122},{"name":129,"role":120,"email":130},"Tara Hansen, BA, BS","EMBRACEStudy@nunm.edu",[132],{"name":119,"affiliation":13,"role":133},"PRINCIPAL_INVESTIGATOR",[135,139,142,145,148,151,154,157,160,163,166],{"pmid":136,"type":137,"citation":138},"20685078","BACKGROUND","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\u002Fj.jclinepi.2010.04.011. Epub 2010 Aug 4.",{"pmid":140,"type":137,"citation":141},"19418100","Krebs 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\u002Fs11606-009-0981-1. Epub 2009 May 6.",{"pmid":143,"type":137,"citation":144},"39772300","Benbir 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\u002Fpcp.2024.23795.",{"pmid":146,"type":137,"citation":147},"38189184","Suri 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\u002Fj.pain.0000000000003150. Epub 2024 Jan 2.",{"pmid":149,"type":137,"citation":150},"34425251","Baumgartner 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\u002Fj.jpain.2021.07.009. Epub 2021 Aug 20.",{"pmid":152,"type":137,"citation":153},"36996174","Baumgartner 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\u002Femo0001228. Epub 2023 Mar 30.",{"pmid":155,"type":137,"citation":156},"38686123","Yu 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\u002Ffpsyt.2024.1333015. eCollection 2024.",{"pmid":158,"type":137,"citation":159},"32536366","Ekholm 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\u002Fjcsm.8636.",{"pmid":161,"type":137,"citation":162},"25871605","Reynolds 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\u002Fajot.2015.015560.",{"pmid":164,"type":137,"citation":165},"39727797","Jain 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\u002Fclinpract14060209.",{"pmid":167,"type":137,"citation":168},"40730349","Guy 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\u002FMLR.0000000000002181. Epub 2025 Jul 3.",[],{"nct_id":4,"conditions":171,"biomarkers":172},[19],[],{"nct_id":4,"found":15,"summary":78,"prompt_version":78}]