Recruiting

Weighted Blanket

Sponsor:

National University of Natural Medicine

Code:

NCT07498491

Conditions

Chronic Pain

Musculoskeletal Pain

Sleep Disturbance

Pain Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Weighted Blanket

Study Details

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

Study ID

NCT07498491

Start date

May 27, 2026

Status verified date

Jun, 2026

Completion date

Sep 15, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 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.

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.

Study Design

Enrollment

44 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Weighted Blanket Nightly Use for Chronic Pain

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.

Interventions

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.

Primary outcome measure

  • Change in self-reported pain intensity [ Time Frame: Baseline to end of intervention (approximately 5 weeks) ]

Central Contacts and Locations

Central contacts

Carina Staab, DC, MEd

503-552-1862cstaab@nunm.edu

Tara Hansen, BA, BS

EMBRACEStudy@nunm.edu

Locations

National University of Natural Medicine

Recruiting

Portland, Oregon, United States, 97201

Contacts

Carina Staab, DC, MEd

503-552-1862cstaab@nunm.edu

More Information

Sponsor

National University of Natural Medicine

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National University of Natural Medicine on 2026-06-17.