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NCT07498491

Weighted Blanket Use for Adults With Chronic Pain

Recruiting
NAAges 18+InterventionalTreatment
National University of Natural Medicine
~44 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Weighted Blanket

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in self-reported pain intensity
Measured over Baseline to end of intervention (approximately 5 weeks)

Conditions

Chronic Pain
Musculoskeletal Pain
Sleep Disturbance
Pain Disorders

Explore related trials

Chronic Pain

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Carina Staab, DC, MEd · PRINCIPAL_INVESTIGATOR · National University of Natural Medicine

Who to contact

Carina Staab, DC, MEd
[email protected]
503-552-1862
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in self-reported pain intensityBaseline 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.