Weighted Blanket for Chronic Pain

(EMBRACE Trial)

CS
TH
Overseen ByTara Hansen, BA, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: National University of Natural Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether using a weighted blanket each night can help adults with chronic pain improve sleep, reduce pain, and enhance daily life. While weighted blankets are known to promote relaxation, their impact on chronic pain remains unclear. Participants will use a weighted blanket nightly for several weeks and report their experiences and any changes in pain or quality of life. Adults who have experienced chronic pain for at least three months and can comfortably lift a weighted blanket may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding how weighted blankets might improve life for those with chronic pain.

What prior data suggests that using a weighted blanket is safe for adults with chronic pain?

Research has shown that weighted blankets are generally safe and easy to use. Studies have found that these blankets can improve sleep and reduce anxiety or depression. Serious side effects rarely occur. Both adults and children have safely used weighted blankets, making them a promising non-drug option for managing long-term conditions like pain.12345

Why are researchers excited about this trial?

Unlike many chronic pain treatments that rely on medications or invasive procedures, the weighted blanket offers a simple, non-pharmacological approach. Researchers are excited about this treatment because it uses deep pressure stimulation, which may help reduce pain perception and improve sleep quality without the side effects associated with drugs. This method is particularly appealing for individuals seeking a more natural and gentle option to manage their pain.

What evidence suggests that a weighted blanket is effective for chronic pain?

Research has shown that weighted blankets might help with chronic pain. One study found that these blankets can ease pain by applying gentle, even pressure, which many people find calming. This pressure might also improve sleep and mood. Participants in this trial will use a weighted blanket nightly. Some users have reported needing less pain medication and feeling less angry. Overall, early findings suggest that weighted blankets could benefit those with chronic pain.14678

Who Is on the Research Team?

CS

Carina Staab, DC, MEd

Principal Investigator

National University of Natural Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who have had chronic pain for at least 3 months. Participants must be able to safely lift and use a weighted blanket (10-25 lbs), sleep with it nightly for about five weeks, keep their habits stable, complete online surveys, and understand English.

Inclusion Criteria

* Participants must have access to the internet, email, and be able to speak, read, and understand English.
I am willing to sleep with a weighted blanket for 35 days.
* Willing to maintain current dietary patterns, activity level, and stable body weight for the duration of the study.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (virtual)

Adjustment Period

Participants undergo a 7-day adjustment period to become accustomed to the weighted blanket

1 week
1 visit (virtual)

Intervention

Participants use the weighted blanket nightly during sleep and complete weekly surveys

4 weeks
Weekly surveys (online)

Follow-up

Participants complete follow-up questionnaires to evaluate changes in pain, sleep, and quality of life

1 week
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Weighted Blanket

Trial Overview

The study tests whether using a weighted blanket each night helps adults with chronic pain improve their sleep, pain levels, and daily life. All participants will use the blanket during sleep over a five-week period while reporting on their experiences through online questionnaires.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Weighted Blanket Nightly Use for Chronic PainExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

National University of Natural Medicine

Lead Sponsor

Trials
34
Recruited
1,400+

Citations

Chronic pain patients low in social connectedness report ...

Furthermore, our findings demonstrate that sensory-affective interventions such as a weighted blanket may be a beneficial tool for chronic pain ...

Chronic Pain Patients Low in Social Connectedness ...

Furthermore, our findings demonstrate that sensory-affective interventions such as a weighted blanket may be a beneficial tool for chronic pain sufferers who ...

Weighted Hug Futon. This weighted blanket has a ...

Positive outcomes were reported for adults, including improved sleep, reduction in medication use, and improved mood. Sleep outcomes

Weighted Blankets for Agitation in Hospitalized Patients ...

Weighted blankets have also been associated with improved chronic pain and reduced anger scores [16,17]. reduces chronic pain:

Weighted Blankets For Autism

Individuals with chronic pain conditions, including fibromyalgia, may find relief through weighted blankets due to the consistent, soothing pressure they ...

"The Effectiveness of Weighted Blankets as a Sleep Promoting ...

Results indicated significant improvements in subjective sleep quality and reductions in insomnia, anxiety, and depressive symptoms, Reduces Chronic Pain:

Feasibility trial of weighted blankets as an intervention for ...

The purpose of this study was to evaluate the safety and feasibility of weighted blankets as a non- pharmacological intervention for ED in pediatric patients ...

Weighted Blankets for Special Children: A Randomized ...

Results. Use of weighted blankets significantly reduced anxiety and physiological markers across both groups. Group 1 showed reductions in ...