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NCT07498491

Weighted Blanket Use for Adults With Chronic Pain

Sponsor: National University of Natural Medicine

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-01

Completion Date

2026-09-15

Last Updated

2026-04-06

Healthy Volunteers

Conditions

Chronic Pain Musculoskeletal Pain Sleep Disturbance Pain Disorders

Interventions

DEVICE

Weighted Blanket

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

Inclusion Criteria: * 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. Exclusion Criteria: * 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.