Weighted Blankets for Post-Surgical Pain

Overseen By Laura K Case, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Opioids

Disqualifiers: Pregnancy, Claustrophobia, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 months

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if blanket weight can affect anxiety before surgery and pain afterward in individuals undergoing breast surgery. Participants will sleep with either a heavier or lighter blanket for three months, or continue using their own bedding, to assess the impact of blanket weight. The study will also examine how changes in anxiety might influence post-surgery pain levels. It is suitable for those undergoing breast surgery who are willing to try a weighted blanket and can safely lift up to 15 pounds. As an unphased trial, this study offers a unique opportunity to explore innovative methods for managing anxiety and pain.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using high-dose opioids, you may not be eligible to participate.

What prior data suggests that weighted blankets are safe for managing anxiety and pain?

Research has shown that most people find weighted blankets comfortable. In past studies, over 60% of participants used a weighted blanket for at least an hour without any problems. Another study found that 70% of people used the blanket for more than an hour, indicating comfort.

There are no major safety concerns with using weighted blankets. They may help with sleep problems and chronic pain. Specifically, one study found that a 15-pound weighted blanket reduced pain for individuals with chronic pain.

Overall, weighted blankets appear safe for general use. They can help with anxiety and pain without causing significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using weighted blankets for post-surgical pain because they offer a non-drug alternative to traditional pain management methods like opioids or NSAIDs, which often come with side effects. Unlike medications, weighted blankets provide a physical method of pain relief, potentially promoting relaxation and reducing discomfort through deep pressure stimulation. This approach could offer a safer, more comfortable option for patients seeking to manage pain without relying on pharmaceuticals.

What evidence suggests that weighted blankets could be effective for reducing anxiety and pain after breast surgery?

Research shows that weighted blankets can help reduce anxiety in people undergoing surgery. In this trial, participants will join different groups to test the effects of weighted blankets. Studies have found that heavier blankets can significantly lessen ongoing pain, likely because the pressure helps calm the nervous system. While lighter blankets are also being tested in this trial, previous studies provide stronger evidence that heavier blankets are better at reducing anxiety and pain. Weighted blankets offer a simple way to potentially ease discomfort at home after surgery. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals scheduled for breast surgery, with a BMI of at least 18.5 and the strength to lift up to 15 pounds. They must be willing to sleep with a weighted blanket for up to three months and use their smartphone to submit data. Pregnant individuals, chronic high-dose opioid users, current/previous weighted blanket users, those with claustrophobia or who are incarcerated cannot participate.

Inclusion Criteria

I can use my smartphone and data plan for the study's app.

I am scheduled for breast surgery.

My BMI is over 18.5 and I can safely lift 15 pounds.

Exclusion Criteria

You are afraid of small, enclosed spaces.

You are currently in jail.

You regularly take a lot of strong painkillers.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either a heavier or lighter blanket overnight for 3 months to assess changes in anxiety and postsurgical pain

3 months

Initial visit for blanket assignment, follow-up assessments at 1 week, 1 month, and 3 months

Follow-up

Participants are monitored for changes in anxiety and pain levels after the treatment period

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Weighted Blanket

Trial Overview

The study is testing if using heavier or lighter blankets before surgery can reduce anxiety and post-surgical pain in patients undergoing breast surgery. It will also explore how these potential changes in pain relate to pre-surgery anxiety levels and identify factors that influence patient responses.

How Is the Trial Designed?

Group I: Lighter blanket Experimental Treatment 1 Intervention

A lighter blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.

Group II: Heavier blanket Experimental Treatment 1 Intervention

A heavier blanket will be worn overnight for 3 months. Blanket weight cannot be disclosed without unblinding participants.

Group III: Waitlist control Active Control 1 Intervention

No blanket will be provided until the end of the study; participants will sleep with their normal bedding.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

Epidural analgesia is more effective than systemic analgesia in managing postoperative pain, leading to benefits like earlier ambulation and hospital discharge.

Spinal opioids and various neural blockade techniques, such as intercostal nerve block, can significantly reduce postoperative pain and narcotic use, improving recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of postoperative pain: review of current techniques and methods. Lutz, LJ., Lamer, TJ.[2019]

Continuous intravenous analgesia with morphine using elastomeric infusors provided effective pain relief for burn patients post-surgery, achieving a visual analog scale (VAS) score of less than 3 within 2 hours of starting treatment.

The method demonstrated a low incidence of side effects compared to traditional morphine delivery methods, with high patient satisfaction, suggesting it is a safe and efficient option for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of postoperative pain for burn patients with intravenous analgesia in continuous perfusion using elastomeric infusors. García Barreiro, J., Rodriguez, A., Cal, M., et al.[2013]

Adequate postoperative pain relief is crucial for improving surgical outcomes, particularly in lower body surgeries, but the effectiveness of opioids administered via patient-controlled analgesia (PCA) or epidural techniques has not shown significant benefits in outcomes.

The best pain relief is achieved through balanced analgesia techniques that combine epidural opioids with local anesthetics and systemic non-steroidal anti-inflammatory drugs, suggesting a multi-faceted approach to pain management is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain relief and clinical outcome: from opioids to balanced analgesia. Kehlet, H.[2005]

Relaxation techniques and music have been found to effectively reduce emotional and observed pain in postoperative patients, although they are less effective in decreasing sensory pain or the need for opioids.

The review highlights significant variability in study designs and methodologies, suggesting that more rigorous randomized controlled trials are needed to determine the most effective types of relaxation and music interventions for pain management in postoperative settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of relaxation and music on postoperative pain: a review. Good, M.[2019]

In a study involving 60 patients undergoing abdominal surgeries, both neostigmine + buprenorphine and ketamine + buprenorphine provided effective postoperative pain relief, with significant reductions in pain scores over 22 hours.

There was no significant difference in pain relief, vital parameters, or side effects between the two treatment groups, indicating that both combinations are safe and effective options for preemptive epidural analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preemptive Epidural Analgesia for Postoperative Pain Relief Revisited: Comparison of Combination of Buprenorphine and Neostigmine with Combination of Buprenorphine and Ketamine in Lower Abdominal Surgeries, A Double-blind Randomized Trial. Choubey, S., Singh, RB.[2022]

Postoperative pain relief methods like nonsteroidal anti-inflammatory drugs and patient-controlled analgesia do not significantly improve surgical outcomes after major procedures, according to several controlled trials.

In lower body surgeries, using epidural or spinal anesthesia for pain relief can reduce blood loss and complications, suggesting that effective pain management may be more beneficial when part of a comprehensive rehabilitation program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does effective postoperative pain management influence surgical morbidity? Rosenberg, J., Kehlet, H.[2017]

In a study of 500 patients undergoing major abdominal surgery, the use of relaxation techniques and music significantly reduced postoperative pain compared to a control group, indicating these methods can be effective adjuncts to opioid medication.

The combination of relaxation and music provided the greatest pain relief, suggesting that these non-pharmacological interventions can enhance patient comfort during recovery, especially when opioid pain relief is insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relief of postoperative pain with jaw relaxation, music and their combination. Good, M., Stanton-Hicks, M., Grass, JA., et al.[2019]

Acute postoperative pain is often not managed effectively worldwide, highlighting a significant gap in patient care that can impact recovery and overall health.

The article discusses new analgesics and advanced delivery methods that could enhance pain management strategies for patients experiencing moderate-to-severe postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain management: new, convenient analgesic therapies. Power, I., McCormack, J.[2019]

Effective pain assessment and management in the recovery room is crucial for postoperative patients, as it significantly impacts their recovery experience and overall satisfaction.

Providing patients with information about their recovery process empowers them and can improve their pain management outcomes, highlighting the importance of communication in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain management in recovery. McMain, L.[2018]

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NCT05324254 | Weighted Blankets for Postsurgical Pain

The weight of blanket a person uses overnight may alter both anxiety and pain levels. The proposed study will determine whether a heavier or lighter blanket ...

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Weighted blankets reduce anxiety in adult surgical patients with moderate to high levels of preoperative anxiety.

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Weighted Blankets for Post-Surgical Pain

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Widespread Pressure Delivered by a Weighted Blanket ...

This randomized-controlled trial showed that a 15-lb weighted blanket produced significantly greater reductions in broad perceptions of chronic pain.

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jpain.org/article/S1526-5900(21)00313-8/fulltext

Widespread Pressure Delivered by a Weighted Blanket ...

Overall, we demonstrate that widespread pressure from a weighted blanket can reduce the severity of chronic pain, offering an accessible, home- ...

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Patient acceptance was measured in this study by ≥ 60% of participants tolerating the blanket for 60 min or more. The intervention group showed ...

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The effect of weighted blankets on sleep and related disorders

Weighted blankets might be a promising tool for sleep interventions among individuals with sleep disorders in clinical settings. More high- ...