Weighted Blanket Use for Adults With Chronic Pain: A Pilot Study

NCT07498491 | Not Yet Recruiting

• 1 other identifier: CS123025
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Pain; Musculoskeletal Pain; Sleep Disturbance; Pain Disorders

Keywords

chronic pain; weighted blanket; pain management; non-pharmacologic pain management; sleep intervention

Outcome Measures

Primary Outcomes (1)

• Change in self-reported pain intensity

  Change in participant-reported pain intensity measured using a validated pain questionnaire (PEG Scale) administered through online surveys. Scores collected at baseline and at the final study visit will be compared to assess changes in pain levels following nightly use of a weighted blanket.

  Baseline to end of intervention (approximately 5 weeks)

Secondary Outcomes (2)

• Change in sleep quality

  Baseline to end of intervention (approximately 5 weeks)

• Change in health-related quality of life

  Baseline to end of intervention (approximately 5 weeks)

Other Outcomes (2)

• Participant adherence to weighted blanket use

  Weekly during the 4-week intervention period

• Participant experience with weighted blanket use

  End of study (approximately 5 weeks)

Study Arms (1)

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.

Device: Weighted Blanket

Interventions

Weighted Blanket DEVICE

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.

Weighted Blanket Nightly Use for Chronic Pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Male and non-pregnant female adult participants must 18 years of age or older
• Duration of pain: at least 3 months
• 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 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.
• Participants must have access to the internet, email, and be able to speak, read, and understand English.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• National University of Natural Medicine: lead

Related Publications (11)

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  PMID: 20685078 BACKGROUND

• 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/s11606-009-0981-1. Epub 2009 May 6.

  PMID: 19418100 BACKGROUND

• 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/pcp.2024.23795.

  PMID: 39772300 BACKGROUND

• 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/j.pain.0000000000003150. Epub 2024 Jan 2.

  PMID: 38189184 BACKGROUND

• 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/j.jpain.2021.07.009. Epub 2021 Aug 20.

  PMID: 34425251 BACKGROUND

• 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/emo0001228. Epub 2023 Mar 30.

  PMID: 36996174 BACKGROUND

• 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/fpsyt.2024.1333015. eCollection 2024.

  PMID: 38686123 BACKGROUND

• 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/jcsm.8636.

  PMID: 32536366 BACKGROUND

• 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/ajot.2015.015560.

  PMID: 25871605 BACKGROUND

• 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/clinpract14060209.

  PMID: 39727797 BACKGROUND

• 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/MLR.0000000000002181. Epub 2025 Jul 3.

  PMID: 40730349 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Parasomnias; Somatoform Disorders; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Carina Staab, DC, MEd

  National University of Natural Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina Staab, DC, MEd

CONTACT

503-552-1862; cstaab@nunm.edu

Tara Hansen, BA, BS

CONTACT

EMBRACEStudy@nunm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share